Fill - Free fillable INVITATIONTO BID (South Africa Department of Health) PDF form

INVITATIONTO

BID



HP10-2021BIO



SUPPLY AND DELIVERY OF SMALL

BIOLOGICAL PREPARATIONS TO THE

DEPARTMENT OF HEALTH FOR THE

PERIOD 1 JANUARY 2021 TO

31 DECEMBER 2022



BID VALIDITY PERIOD: 120 DAYS

No Briefing Session will be held

All tender related enquiries can be mailed to

tenders@health.gov.za

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Bidder Signature:____________________________

HP10-2021BIO Page 1

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Bidder Signature:____________________________

HP10-2021BIO Page 2

CONTACT PERSONS AT THE NATIONAL DEPARTMENT OF HEALTH

Please direct any queries relating to the bidding process to tenders@health.gov.za



BID DOCUMENTS FOR COMPLETION AND SUBMISSION

All bid documents listed below must be sorted, filed and submitted in the exact compilation

sequence as indicated below and in Annexure A attached.

Submission of bid documents is mandatory, unless it's not applicable and indicated as such

in the "N/A" column in the Bid Document Check List.

All bid documents must be signed.

Bidders not complying to any of the requirements will be deemed to be non-responsive and

will not be considered for evaluation.

 Covering Letter i.e. limited stock availability of any item offered, non-compliance;

 Status relating to TAX, B-BBEE, License to Manufacture, Certificates etc. Bid Signature;

 Resolution/Authority to sign bid;

 Bid/File Index;

 PBD 4.1: Contact Details of Bidder;

 SBD 1: Invitation to bid;

 Tax Clearance Pin Issued;

 CSD Registration report - A certified copy of latest and complete report. Note: CSD

summary report will not be accepted;

 SBD 4: Declaration of interest;

 PBD9: Directors: Categorisation by race, gender and disability;

 SBD5: The National Industrial Participation Programme;

 SBD 6(1): Preference Points Claimed (B-BBEE);

 Valid B-BBEE certificate (certified copy) or Sworn Affidavit to claim preference points;

 SBD 8: Declaration of Past SCM Practices;

 SBD 9: Certificate of Independent Bid Determination;

 PBD1: Authorisation Declaration Note: Non-compliance to submission of a valid

authorisation declaration, where applicable, may invalidate the bid;

 PBD 1.1: List of products offered sourced from third party;

 PBD 1.2: Unconditional written undertaking from the third party;

 PBD5: Good Manufacturing Practice (GMP). Declaration of compliance;

 PBD 8: Special Requirements and Conditions of Contact. Declaration of compliance;

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Bidder Signature:____________________________

HP10-2021BIO Page 3

 CIPC/CIPRO or proof of ownership/shareholding. Certified copies of registration

certificates;

 Proof of company cedings, mergers and name changes;

 Certified copy of Licence to manufacture or import (in the name of the bidder),

including all annexures;

 Certified copy of Licence to manufacture medicines, including all annexures for local

manufacturing sites as listed on the MRC of the bidder (applicant);

 Certified copies of Medicine Registration Certificates (MRC) with all the associated

conditions of registration (Annexure). Note: All MRC's must be marked by the

bidder with the relevant item number and be sorted and filed in numerical order;

 Original Package Insert (PI) or document detailing professional information approved by

the Medicines Control Council (MCC) or the South African Health Products Regulatory

Authority (SAHPRA) for each product offered. Note: All PI`s must be marked with the

relevant item number and be sorted and filed/submitted in numerical

 order;

 Proof of sample submission;

 Bidder`s item list (List of products offered); and

 Signed Excel Bid Response Pricing Schedule (All prices must be submitted in 2 (two)

decimals). If the Excel Bid response Pricing Schedule is not signed in the space

provided, the bid will not be considered for evaluation.

COMPLETION OF DOCUMENTS AND BID SUBMISSION

Bidders are required to submit three sets of bid documents according to the instructions

below. All three sets must be submitted not later than the closing date and time. Set 2 and

Set 3 must be included on a CD with Set 1 submitted in a sealed package. The full name

and address of the bidder, including the return address, the bid number and the closing

date must be clearly indicated on the package. All fields must be completed. Where

information requested is not relevant this should be indicated with N/A.

Set 1: Hard copy (legally binding bid documents)

Bidders must complete all SBD, PBD and Bid Response forms in black ink, typed. Where

no electronic entry field is provided bidders must complete the forms in black ink,

handwritten in capital letters. The signed hard copy of the bid document will serve as the

legal bid document.

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 4

Bidders must submit their complete bid in hard copy format (paper document). The Chief

Executive Officer, Chief Financial Officer, or authorised designee of the entity submitting the

bid must sign the official signature pages. All pages in the complete bid document must be

initialed by same with black ink. The use of correction fluid is not acceptable. Any change/s

must be clearly indicated and initialed.

As the National Department of Health complies with the regulations made under the

Disaster Management Act, 2002, published in the Gazette 18 March 2020 no briefing

session of public bid opening will be held. However, Bidders must still ensure that bids are

delivered on time to the correct address and deposited in the Tender Box. Late bids will not

be accepted for consideration.

Bidders must refrain from using binding methods like coil, comb, wire velobind,

screw binding etc. It is requested that bidders pre-punch two holes on the left hand

side of bid documents suitable for filing in a two hole lever arch file. Bid documents

should be tied in parcels using string or rope that can be easily untied for filing

purposes.

Set 2: PDF of Hard Copy, signed legal documents. (i.e. pdf of Set 1)

Bidders must submit a PDF version of the entire signed hardcopy bid, including all

certificates and documents requested.

Set 3: Electronic version of bid documents

Bidders must submit the electronic versions (editable pdf) of all SBD and PBD documents,

Bid Response Document and other relevant spreadsheets in Excel (not pdf).

All three sets of information must be submitted in order for the bid to be evaluated.

Bidders must ensure that the price quoted for a product (line item) on the Excel Bid

Response Document is for the unit pack specified. No conversion factors will be applied.

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 5

INVITATION TO BID

SBD 1

YOU ARE HEREBY INVITED TO BID FOR REQUIREMENTS OF THE NATIONAL

DEPARTMENT OF HEALTH

BID NUMBER: HP10-2021BIO

CLOSING DATE: 8 JUNE 2020 CLOSING TIME:11:00

DESCRIPTION Supply and Delivery of Small Biological Preparations to the Department of

Health for the period 1 January 2021 to 31 December 2022

Bid documents must be addressed as follows and delivered before the closing date and time:

Addressed to:

The Director-General: Health

Civitas Building

C/o Struben and Thabo Sehume Streets,

Pretoria

Delivered to:

Pharmaceutical Tender Box

Reception Area

National Department of Health

Civitas Building,

C/o Struben and Thabo Sehume Streets,

Pretoria

Bidders should ensure that bids are delivered on time to the correct address and deposited

in the Pharmaceutical Tender Box. Late bids will not be accepted for consideration

The Pharmaceutical Tender Box is generally accessible during extended working hours.

See below for map locating Civitas Building within Pretoria Central Business District.

ALL BIDS MUST BE SUBMITTED ON THE OFFICIAL FORMS

This competitive bidding process is subject to the Preferential Procurement Policy Framework Act

and the Preferential Procurement Regulations, 2011, the General Conditions of Contract (GCC)

and, if applicable, any other Special Requirements and Conditions of Contract.



2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 6

SBD1

PART A

INVITATION TO BID

YOU ARE HEREBY INVITED TO BID FOR REQUIREMENTS OF THE NATIONAL DEPARTMENT OF HEALTH

BID NUMBER: HP10-2021BIO CLOSING DATE: 8 JUNE 2020 CLOSING TIME: 11:00

DESCRIPTION SUPPLY AND DELIVERY OF SMALL BIOLOGICAL PREPARATIONS TO THE DEPARTMENT OF HEALTH FOR THE PERIOD

1 JANUARY 2021 TO 31 DECEMBER 2022

BID RESPONSE DOCUMENTS MAY BE DEPOSITED IN THE BID BOX SITUATED AT C/O STRUBEN AND THABO SEHUME STREETS

PHARMACEUTICAL TENDER BOX

RECEPTION AREA

NATIONAL DEPARTMENT OF HEALTH

CIVITAS BUILDING

BIDDING PROCEDURE ENQUIRIES MAY BE DIRECTED TO TECHNICAL ENQUIRIES MAY BE DIRECTED TO:

CONTACT PERSON CONTACT PERSON

TELEPHONE NUMBER TELEPHONE NUMBER

FACSIMILE NUMBER FACSIMILE NUMBER

E-MAIL ADDRESS TENDERS@HEALTH.GOV.ZA E-MAIL ADDRESS TENDERS@HEALTH.GOV.ZA

SUPPLIER INFORMATION

NAME OF BIDDER

POSTAL ADDRESS

STREET ADDRESS

TELEPHONE NUMBER CODE NUMBER

CELLPHONE NUMBER

FACSIMILE NUMBER CODE NUMBER

E-MAIL ADDRESS

VAT REGISTRATION

NUMBER

SUPPLIER

COMPLIANCE

STATUS

TAX

COMPLIANCE

SYSTEM PIN:

CENTRAL

SUPPLIER

DATABASE

No: MAAA

B-BBEE STATUS

LEVEL VERIFICATION

CERTIFICATE

TICK APPLICABLE BOX]

Yes No

B-BBEE STATUS LEVEL SWORN

AFFIDAVIT

[TICK APPLICABLE BOX]

Yes No

[A B-BBEE STATUS LEVEL VERIFICATION CERTIFICATE/ SWORN AFFIDAVIT (FOR EMES & QSEs) MUST BE SUBMITTED IN

ORDER TO QUALIFY FOR PREFERENCE POINTS FOR B-BBEE]

ARE YOU THE

ACCREDITED

REPRESENTATIVE IN

SOUTH AFRICA FOR

THE GOODS

/SERVICES /WORKS

OFFERED?

Yes No

[IF YES ENCLOSE PROOF]

ARE YOU A FOREIGN BASED

SUPPLIER FOR THE GOODS

/SERVICES /WORKS OFFERED?

Yes No

[IF YES, ANSWER THE

QUESTIONNAIRE BELOW ]

QUESTIONNAIRE TO BIDDING FOREIGN SUPPLIERS

IS THE ENTITY A RESIDENT OF THE REPUBLIC OF SOUTH AFRICA (RSA)? YES NO

DOES THE ENTITY HAVE A BRANCH IN THE RSA?

YES NO

DOES THE ENTITY HAVE A PERMANENT ESTABLISHMENT IN THE RSA?

YES NO

DOES THE ENTITY HAVE ANY SOURCE OF INCOME IN THE RSA?

YES NO

IS THE ENTITY LIABLE IN THE RSA FOR ANY FORM OF TAXATION?

YES NO

IF THE ANSWER IS “NO” TO ALL OF THE ABOVE, THEN IT IS NOT A REQUIREMENT TO REGISTER FOR A TAX COMPLIANCE STATUS

SYSTEM PIN CODE FROM THE SOUTH AFRICAN REVENUE SERVICE (SARS) AND IF NOT REGISTER AS PER 2.3 BELOW.

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 7

SBD1

PART B

TERMS AND CONDITIONS FOR BIDDING

1. BID SUBMISSION:

1.1. BIDS MUST BE DELIVERED BY THE STIPULATED TIME TO THE CORRECT ADDRESS. LATE BIDS WILL NOT BE ACCEPTED FOR

CONSIDERATION.

1.2. ALL BIDS MUST BE SUBMITTED ON THE OFFICIAL FORMS PROVIDED–(NOT TO BE RE-TYPED) OR IN THE MANNER PRESCRIBED IN

THE BID DOCUMENT.

1.3. THIS BID IS SUBJECT TO THE PREFERENTIAL PROCUREMENT POLICY FRAMEWORK ACT, 2000 AND THE PREFERENTIAL

PROCUREMENT REGULATIONS, 2017, THE GENERAL CONDITIONS OF CONTRACT (GCC) AND, IF APPLICABLE, ANY OTHER

SPECIAL CONDITIONS OF CONTRACT.

1.4. THE SUCCESSFUL BIDDER WILL BE REQUIRED TO FILL IN AND SIGN A WRITTEN CONTRACT FORM (SBD7).

2. TAX COMPLIANCE REQUIREMENTS

2.1 BIDDERS MUST ENSURE COMPLIANCE WITH THEIR TAX OBLIGATIONS.

2.2 BIDDERS ARE REQUIRED TO SUBMIT THEIR UNIQUE PERSONAL IDENTIFICATION NUMBER (PIN) ISSUED BY SARS TO ENABLE THE

ORGAN OF STATE TO VERIFY THE TAXPAYER’S PROFILE AND TAX STATUS.

2.3 APPLICATION FOR TAX COMPLIANCE STATUS (TCS) PIN MAY BE MADE VIA E-FILING THROUGH THE SARS WEBSITE

WWW.SARS.GOV.ZA.

2.4 BIDDERS MAY ALSO SUBMIT A PRINTED TCS CERTIFICATE TOGETHER WITH THE BID.

2.5 IN BIDS WHERE CONSORTIA / JOINT VENTURES / SUB-CONTRACTORS ARE INVOLVED, EACH PARTY MUST SUBMIT A SEPARATE

TCS CERTIFICATE / PIN / CSD NUMBER.

2.6 WHERE NO TCS PIN IS AVAILABLE BUT THE BIDDER IS REGISTERED ON THE CENTRAL SUPPLIER DATABASE (CSD), A CSD

NUMBER MUST BE PROVIDED.

2.7 NO BIDS WILL BE CONSIDERED FROM PERSONS IN THE SERVICE OF THE STATE, COMPANIES WITH DIRECTORS WHO ARE

PERSONS IN THE SERVICE OF THE STATE, OR CLOSE CORPORATIONS WITH MEMBERS PERSONS IN THE SERVICE OF THE

STATE.”

NB: FAILURE TO PROVIDE / OR COMPLY WITH ANY OF THE ABOVE PARTICULARS MAY RENDER THE BID INVALID.

SIGNATURE OF BIDDER: ……………………………………………

CAPACITY UNDER WHICH THIS BID IS SIGNED: ……………………………………………

(Proof of authority must be submitted e.g. company resolution)

DATE: …………………………………………...

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 8

PBD4.1

Private Bag X828, PRETORIA, 0001. Civitas Building Cnr Thabo Sehume & Struben Streets, PRETORIA 0001

Directorate: Access to Affordable Medicines Tel: (012) 395 8130 Fax: (012) 395 8823/4

NTRA

SUPPLIER DETAILS:

Note that Provincial Departments of Health will require separate registration of suppliers on their Databases

& could request completion of Province-specific documents.

If a contract is awarded, full detail for supplier registration or verification will be requested.

Should any of the detail provided below change, please advise the National Department of Health

immediately in writing with detail of such change(s).

CONTACT DETAIL

1. Supplier Registered Name

Legal entity / corresponding

with banking detail

2. Contact person regarding contract enquiries (to be printed on contract cover)

Name &

Surname

e-mail

Telephone

Fax

Cell

Other

3. Contact regarding orders

Address for posting of orders

Fax

Tel

(confirmation)

EDI

Order

enquiries

Name & surname:

Tel

e-mail

National

key

Account

Manager (or Tender Manager)

Name

e-mail

Telephone

Cell

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 9

HP10-2021BIO

SIGNATURE FOR PBD4.1

I / we, the undersigned, herewith certify that all of the above information is correct at the time of

completion. I/ we furthermore certify that I / we have the appropriate authority to furnish the above-

mentioned information on behalf of our employer.

Name:

Signature

Designation:

Date

Name:

Signature

Designation:

Date

PBD 4.1

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 10

SBD 6.1

PREFERENCE POINTS CLAIM FORM IN TERMS OF THE PREFERENTIAL

PROCUREMENT REGULATIONS 2017

This preference form must form part of all bids invited. It contains general information and

serves as a claim form for preference points for Broad-Based Black Economic Empowerment

(B-BBEE) Status Level of Contribution

NB: BEFORE COMPLETING THIS FORM, BIDDERS MUST STUDY THE GENERAL

CONDITIONS, DEFINITIONS AND DIRECTIVES APPLICABLE IN RESPECT OF B-

BBEE, AS PRESCRIBED IN THE PREFERENTIAL PROCUREMENT

REGULATIONS, 2017.

1. GENERAL CONDITIONS

1.1 The following preference point systems are applicable to all bids:

- the 80/20 system for requirements with a Rand value of up to R50 000 000 (all

applicable taxes included); and

- the 90/10 system for requirements with a Rand value above R50 000 000 (all

applicable taxes included).

1.2

a) The value of this bid is estimated to exceed R50 000 000 (all applicable taxes included)

and therefore the 90/10 preference point system shall be applicable; or

b) Either the 80/20 or 90/10 preference point system will be applicable to this tender

(delete whichever is not applicable for this tender).

1.3 Points for this bid shall be awarded for:

(a) Price; and

(b) B-BBEE Status Level of Contributor.

1.4 The maximum points for this bid are allocated as follows:

POINTS

PRICE

B-BBEE STATUS LEVEL OF CONTRIBUTOR

Total points for Price and B-BBEE must not

exceed

100

1.5 Failure on the part of a bidder to submit proof of B-BBEE Status level of contributor

together with the bid, will be interpreted to mean that preference points for B-BBEE status

level of contribution are not claimed.

1.6 The purchaser reserves the right to require of a bidder, either before a bid is adjudicated

or at any time subsequently, to substantiate any claim in regard to preferences, in any

manner required by the purchaser.

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 11

Page 2 of 5

2. DEFINITIONS

(a) “B-BBEE” means broad-based black economic empowerment as defined in section

1 of the Broad-Based Black Economic Empowerment Act;

(b) “B-BBEE status level of contributor” means the B-BBEE status of an entity in terms

of a code of good practice on black economic empowerment, issued in terms of

section 9(1) of the Broad-Based Black Economic Empowerment Act;

invitation by an organ of state for the provision of goods or services, through price

quotations, advertised competitive bidding processes or proposals;

(d) “Broad-Based Black Economic Empowerment Act” means the Broad-Based

Black Economic Empowerment Act, 2003 (Act No. 53 of 2003);

(e) “EME” means an Exempted Micro Enterprise in terms of a code of good practice on

black economic empowerment issued in terms of section 9 (1) of the Broad-Based

Black Economic Empowerment Act;

(f) “functionality” means the ability of a tenderer to provide goods or services in

accordance with specifications as set out in the tender documents.

(g) “prices” includes all applicable taxes less all unconditional discounts;

(h) “proof of B-BBEE status level of contributor” means:

1) B-BBEE Status level certificate issued by an authorized body or person;

2) A sworn affidavit as prescribed by the B-BBEE Codes of Good Practice;

3) Any other requirement prescribed in terms of the B-BBEE Act;

(i) “QSE” means a qualifying small business enterprise in terms of a code of good

practice on black economic empowerment issued in terms of section 9 (1) of the

Broad-Based Black Economic Empowerment Act;

(j) “rand value” means the total estimated value of a contract in Rand, calculated at the

time of bid invitation, and includes all applicable taxes;

3. POINTS AWARDED FOR PRICE

3.1 THE 80/20 OR 90/10 PREFERENCE POINT SYSTEMS

A maximum of 80 or 90 points is allocated for price on the following basis:

80/20 or 90/10

















min

180

PPt

















min

190

PPt

Where

Ps = Points scored for price of bid under consideration

Pt = Price of bid under consideration

Pmin = Price of lowest acceptable bid

4. POINTS AWARDED FOR B-BBEE STATUS LEVEL OF CONTRIBUTOR

4.1 In terms of Regulation 6 (2) and 7 (2) of the Preferential Procurement Regulations,

preference points must be awarded to a bidder for attaining the B-BBEE status level of

contribution in accordance with the table below:

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 12

Page 3 of 5

B-BBEE Status Level of

Contributor

Number of points

(90/10 system)

Number of points

(80/20 system)

1 10 20

2 9 18

3 6 14

4 5 12

5 4 8

6 3 6

7 2 4

8 1 2

Non-compliant

contributor

0 0

5. BID DECLARATION

5.1 Bidders who claim points in respect of B-BBEE Status Level of Contribution must

complete the following:

6. B-BBEE STATUS LEVEL OF CONTRIBUTOR CLAIMED IN TERMS OF

PARAGRAPHS 1.4 AND 4.1

6.1 B-BBEE Status Level of Contributor: . = ………(maximum of 10 or 20 points)

(Points claimed in respect of paragraph 7.1 must be in accordance with the table

reflected in paragraph 4.1 and must be substantiated by relevant proof of B-BBEE

status level of contributor.

7. SUB-CONTRACTING

7.1 Will any portion of the contract be sub-contracted?

(Tick applicable box)

YES

7.1.1 If yes, indicate:

i) What percentage of the contract will be

subcontracted............…………….…………%

ii) The name of the sub-contractor…………………………………………………………..

iii) The B-BBEE status level of the sub-contractor......................................……………..

iv) Whether the sub-contractor is an EME or QSE

(Tick applicable box)

YES

v) Specify, by ticking the appropriate box, if subcontracting with an enterprise in terms

of Preferential Procurement Regulations,2017:

Designated Group: An EME or QSE which is at last 51% owned

by:

EME

√

QSE

√

Black people

Black people who are youth

Black people who are women

Black people with disabilities

Black people living in rural or underdeveloped areas or townships

Cooperative owned by black people

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 13

Page 4 of 5

Black people who are military veterans

Any EME

Any QSE

8. DECLARATION WITH REGARD TO COMPANY/FIRM

8.1 Name of

company/firm:…………………………………………………………………………….

8.2 VAT registration

number:……………………………………….…………………………………

8.3 Company registration

number:…………….……………………….…………………………….

8.4 TYPE OF COMPANY/ FIRM

 Partnership/Joint Venture / Consortium

 One person business/sole propriety

 Close corporation

 Company

 (Pty) Limited

ICK APPLICABLE BOX]

8.5 DESCRIBE PRINCIPAL BUSINESS ACTIVITIES

……………………………………………………………………………………………………

……..

8.6 COMPANY CLASSIFICATION

 Manufacturer

 Supplier

 Professional service provider

 Other service providers, e.g. transporter, etc.

ICK APPLICABLE BOX]

8.7 Total number of years the company/firm has been in business:……………………………

8.8 I/we, the undersigned, who is / are duly authorised to do so on behalf of the

company/firm, certify that the points claimed, based on the B-BBE status level of

contributor indicated in paragraphs 1.4 and 6.1 of the foregoing certificate, qualifies the

company/ firm for the preference(s) shown and I / we acknowledge that:

i) The information furnished is true and correct;

ii) The preference points claimed are in accordance with the General Conditions as

indicated in paragraph 1 of this form;

iii) In the event of a contract being awarded as a result of points claimed as shown in

paragraphs 1.4 and 6.1, the contractor may be required to furnish documentary

proof to the satisfaction of the purchaser that the claims are correct;

iv) If the B-BBEE status level of contributor has been claimed or obtained on a

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 14

Page 5 of 5

fraudulent basis or any of the conditions of contract have not been fulfilled, the

purchaser may, in addition to any other remedy it may have –

(a) disqualify the person from the bidding process;

(b) recover costs, losses or damages it has incurred or suffered as a

result of that person’s conduct;

a result of having to make less favourable arrangements due to such

cancellation;

(d) recommend that the bidder or contractor, its shareholders and

directors, or only the shareholders and directors who acted on a

fraudulent basis, be restricted by the National Treasury from

obtaining business from any organ of state for a period not

exceeding 10 years, after the audi alteram partem (hear the other

side) rule has been applied; and

(e) forward the matter for criminal prosecution.

……………………………………….

SIGNATURE(S) OF BIDDERS(S)

DATE: …………………………………..

ADDRESS …………………………………..

…………………………………..

WITNESSES

1. ……………………………………..

2. …………………………………….

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 15

HP10-2021BIO

DIRECTORS: CATEGORISATION OF RACE, GENDER AND DISABILITY

COMPLETE ALL FIELDS ELECTRONICALLY AND SIGN

PBD9

Full Names Surname

Identity Number or

foreigner Passport

Number

Age

(Number)

Race

Gender

(Male/Female)

Disability

(Yes/No)

8 May 2020 Page 1 of 3 SIGNED: ____________________________

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 16





DECLARATION OF

INTEREST

1. Any legal person, including persons employed by the state¹, or persons having a

kinship

with

persons employed by the state, including a blood relationship, may make an offer

offers in

terms of this invitation to bid (includes an advertised competitive bid, a limited bid,

proposal or

written price quotation). In view of possible allegations of favouritism, should

the

resulting bid, or

part thereof, be awarded to persons employed by the state, or

persons connected

with or related to them, it is required that the bidder or

his/her

authorized representative

declare his/her position in relation to the

evaluating/adjudicating

authority

where-

- the bidder is employed by the state;

and/or

- the legal person on whose behalf the bidding document is signed, has

relationship with persons/a person who are/is involved in the evaluation and

adjudication of

the bid(s), or where it is known that such a relationship

exists

between the person or

persons for or on whose behalf the declarant acts

and

persons who are involved with the

evaluation and or adjudication of the

bid.

2. In order to give effect to the above, the following questionnaire must be completed

and

submitted with the

bid.

2.1 Full name of bidder :

2.1.1 Represented by (Full Name):

2.2 Identity Number:

2.3 Position occupied in the company (director,

trustee, shareholder, member)

2.4 Registration number of company, enterprise,

close corporation, partnership agreement or trust

2.5 Tax Reference Number:

2.6 VAT Registration Number:

The names of all directors / trustees / shareholders / members, their individual identity

numbers,

tax reference

numbers and, if applicable, employee/PERSAL numbers must be indicated

paragraph 3

below

2.7 Are you or any person connected with the bidder

presently employed by the state?

If so, furnish the following particulars

Yes

2.7.1 Name of person / director / trustee / shareholder /

member:

Name of state institution at which you or the person

connected to the bidder is employed:

Position occupied in the state institution:

Any other particulars

2.7.2 If you are presently employed by the state, did you

obtain the appropriate authority to undertake

remunerative work outside employment in the public

sector?

Yes

If yes, did you attach proof of such aut hority to th e

bid document?

Yes

2.7.3 If no, furnish reasons for non-submission of such

proof:

Note: Failure to submit proof of such authority, where

applicable, may result in

disqualification of the

bid.)

SBD

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 17

2.8 Did you or your spouse, or any of the

company’s directors /trustees / shareholders

/members or their spouses conduct

business with the state in the previous

twelve months?

Yes

2.8.1 If so, furnish particulars:

2.9 Do you, or any person with the bidder, have

any relationship (family, friend, other) with a

person employed by the state and who may

be involved with the evaluation and or

adjudication of this bid?

Yes

2.9.1 If so, furnish particulars:

2.10 Are you, or any person connected with the

bidder, aware of any relationship (family,

friend, other) between any other bidder

and any person employed by the state

who may be involved with the evaluation

and or adjudication of this bid?

Yes

2.10.1 If so, furnish particulars:

2.11 Do you or any of the directors / trustees /

shareholders / members of the company

have any interest in any other related

companies whether or not they are bidding

for this contract?

Yes

2.11.1 If so, furnish particulars:

¹“State” means

–

(a)

any national or provincial department, national or provincial public entity or constitutional institution within the meaning of

the

Public Finance Management Act, 1999 (Act No.

of 1999);

(b)

any municipality or municipal

entity;

(c)

provincial

legislature;

(d)

national Assembly or the national Council

provinces;

(e) Parliament.

²”Shareholder” means

person who owns shares in the company and

actively involved in the management of the enterprise

business and exercises control over the

enterprise

3 Full details of directors/trustees/members/shareholders. (Attach schedule if space insufficient)

Full Name

Identity Number

Personal Income Tax

Reference Number

State Employee Number

/ Persal Number

SBD 4

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 18



4. DECLARATION

I, the undersigned (full name)

Certify that the information furnished in paragraphs 2 and 3 above is correct.

I accept that the state may reject the bid or act against me should this declaration prove to

be false

Name of bidder

Position

Signature

Date

SBD

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 19



This document must be signed and submitted together with your bid

THE NATIONAL INDUSTRIAL PARTICIPATION P

ROGRAMME

INTRODUCTION

The National Industrial Participation (NIP) Programme, which is applicable to all government

procurement contracts that have an imported content, became effective on the 1 September 1996.

The NIP policy and guidelines were fully endorsed by Cabinet on 30 April 1997. In terms of the

Cabinet decision, all state and parastatal purchases / lease contracts (for goods, works and

services) entered into after this date, are subject to the NIP requirements. NIP is obligatory and

therefore must be complied with. The Industrial Participation Secretariat (IPS) of the Department of

Trade and Industry (DTI) is charged with the responsibility of administering the programme.

1. PILLARS OF THE PROGRAMME

1.1 The NIP obligation is benchmarked on the i m p o r t e d content of the c o n t r a c t . Any

contract having an imported content equal t o or exceeding US$ 10 million or other

currency equivalent to US$ 10 million will have a NIP obligation. This threshold of US$ 10

million can be reached as follows:

a) Any single contract with imported content exceeding US$10 million.

b) Multiple contracts for the same goods, works or services each with imported content

exceeding US$3 million awarded to one seller over a 2 year period which in total exceeds

US$10 million.

c) A contract with a renewable option clause, where should the option be exercised the total

value of the imported content will exceed US$10 million.

d) Multiple suppliers of the same goods, works or services under the same contract, where the

value of the imported content of each allocation is equal to or exceeds US$ 3 million worth

of goods, works or services to the same government institution, which in total over a two (2)

year period exceeds US$10 million.

1.2 The NIP obligation applicable to suppliers in respect of sub-paragraphs 1.1 (a) to 1.1 (c)

above will amount to 30% of the imported content whilst suppliers in respect of paragraph 1.1

(d) shall incur 30% of the total NIP obligation on a pro-rata basis.

1.3 To satisfy the NIP obligation, the DTI would negotiate and conclude agreements such as

investments, joint ventures, sub-contracting, licensee production, export promotion, sourcing

arrangements and

research

and development (R&D)

with

partners

or suppliers.

1.4 A period of seven years has been identified as the time frame within which to

discharge

the

obligation.

2 REQUIREMENTS OF THE DEPARTMENT OF TRADE AND

INDUSTRY

2.1 In order to ensure effective implementation of the programme, successful bidders

(contractors) are required to, immediately after the award of a contract that is in excess of

R10 million (ten million Rands), submit details of such a contract to the DTI for reporting

purposes.

2.2 The purpose for reporting details of contracts in excess of the amount of R10 million (ten

million Rands) is to cater for multiple contracts for the same goods, works or services;

renewable contracts and multiple suppliers for the same goods, works or services under the

same contract as provided for in paragraphs 1.1.(b) to 1.1. (d) above.

SBD5

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 20



3 BID SUBMISSION AND CONTRACT REPORTING

REQ

UIRE

S O F BIDDERS AND

SUCCESSFUL BIDDERS (CONTRACTORS)

3.1 Bidders are required to

sign

and submit this

Standard

Bidding

Document (SBD

5) together with the

bid on the closing date and time.

3.2 In order to accommodate multiple contracts for the same goods, works or services;

renewable contracts and multiple suppliers for the same goods, works or services under the

same contract as indicated in sub-paragraphs 1.1 (b) to 1.1 (d) above and to enable the DTI

in determining the NIP obligation, successful bidders (contractors) are required, immediately

after being officially notified about any successful bid with a value in excess of R10 million (ten

million Rands), to contact and furnish the DTI with the following information:

• Bid/contract number.

• Description of the goods works or services.

• Date on which the contract was accepted.

• Name, address and contact details of the government institution.

• Value of the contract.

• Imported content of the contract, if possible.

3.3 The information required in paragraph 3.2 above must be sent to the Department of Trade and

Industry, Private Bag X84, Pretoria, 0001 for the attention of Mr Elias Malapane within

five (5) working days after award of the contract. for further details about the programme,

contact Mr Malapane on telephone (012) 394 1401, facsimile (012) 394 2401 or e-mail at

Elias@thedti.gov.za .

4 PROCESS TO SATISFY THE NIP OBLIGATION

4.1 Once the successful bidder (contractor) has made contact with and furnished the DTI with the

information required, the following steps will be followed:

a) the contractor and the DTI will determine the NIP obligation;

b) the contractor and the DTI will sign the NIP obligation agreement;

c) the contractor will submit a performance guarantee to the DTI;

d) the contractor will submit a business concept for consideration and approval by the DTI;

e) upon approval of the business concept by the DTI, the contractor will submit detailed

business plans outlining the business concepts;

f) the contractor will implement the business plans; and

g) the contractor will submit bi-annual progress reports on approved plans to the DTI.

4.2 The NIP obligation agreement is between the DTI and the successful bidder (contractor) and,

therefore, does not involve the purchasing institution.

Bid number

Closing

date:

Name of bidder

Postal Address

Postal Code

Name in print

Position

Signature:

Date:

SBD5

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 21

HP10-2021BIO

08/06/2020



DECLARATION OF BIDDER’S PAST SUPPLY CHAIN MANAGEMENT

PRACTICES

1 This Standard Bidding Document must form part of all bids invited.

2 It serves as a declaration to be used by institutions in ensuring that when goods and

services are being procured, all reasonable steps are taken to combat the abuse of

the supply chain management system.

3 The bid of any bidder may be disregarded if that bidder or any of its directors have- a)

abused the institution’s supply chain management system;

b) committed fraud or any other improper conduct in relation to such system; or

c) failed to perform on any previous contract.

4 In order to give effect to the above, the following questionnaire must be

completed and submitted with the bid.

Item Question Yes No

4.1 Is the

bidder

or any of its

directors listed

on the

National

Treasury’s

Database

Restricted

Suppliers as

companies

or persons

prohibited

from

doing

business

with the

public

sector?

(Companies or persons who are listed on this Database were informed in

writing of this restriction by the Accounting Officer/Authority of the institution that

imposed the restriction after the audi alteram partem rule was applied).

The Database of Restricted Suppliers now resides on the National

Treasury’s website (www.treasury.gov.za) and can be accessed by

clicking on its link at the bottom of the home page.

4.1.1 If so, furnish particulars:

4.2

Is the bidder or any of its directors listed on the Register for Tender

Defaulters

in terms of section 29 of the

Prevention

and

Combating

Corrupt Activities Act (No 12 of 2004)?

Treasury’s website

(www.treasury.gov.za)

by clicking on its link at the

bottom of the home page.

4.2.1 If so, furnish particulars:

SBD8

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 22



4.3

Was the bidder or any of its directors

convicted

by a court of law

(including

a court outside of the Republic of South Africa) for fraud or

corruption

during the past five years?

4.3.1 If so, furnish particulars:

4.4 Was any contract between the bidder and any organ of state terminated

during the past five years on account of failure to perform on or comply with

the contract?

4.4.1 If so, furnish particulars:

Certification

I, the undersigned

certify that the information furnished on this declaration form is true and correct. I accept that, in

addition to cancellation of a contract, action may be taken against me should this declaration prove

to be false.

I accept that the state may reject the bid or act against me should t h i s declaration prove to be

false.

Name of bidder:

Position:

Signature:

Date

SBD8

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 23



CERTIFICATE OF INDEPENDENT BID

DETERMINATION

1. This Standard Bidding Document (SBD) must form part of all bids¹

invited.

Section 4 (1) (b) (iii) of the Competition Act No. 89 of 1998, as amended, prohibits

agreement between, or concerted practice by, firms, or a decision by an association

firms, if

it is between parties in a horizontal relationship and if it involves

collusive

bidding (or bid

rigging).² Collusive bidding is a pe se prohibition meaning that it

cannot

be justified under any

grounds.

¹ Includes price quotations, advertised competitive bids, limited bids and

proposals.

² Bid rigging (or collusive bidding) occurs when businesses, that would otherwise be expected to

compete, secretly conspire to

raise

prices or lower the quality of goods and / or services for

purchasers who wish to acquire goods and / or services through

bidding process. Bid rigging is,

therefore, an agreement between competitors not to

compete

Treasury Regulation 16A9 prescribes that accounting officers and accounting

authorities

must

take all reasonable steps to prevent abuse of the supply chain management

system

and authorizes

accounting officers and accounting authorities

to:

a. disregard the bid of any bidder if that bidder, or any of its directors

have

abused the institution’s supply chain management system and or committed

fraud

or any

other improper conduct in relation to such

system.

b. cancel a contract awarded to a supplier of goods and services if the

supplier

committed any corrupt or fraudulent act during the bidding process or the

execution

of that

contract.

4. This SBD serves as a certificate of declaration th at would be used by institutions to en sure

that, when bids are considered, reasonable steps are taken to prevent any form of bid rigging.

5. In order to give effect to the above, the attached Certificate of Bid Determination (SBD9) must be

completed and submitted with the bid:

CERTIFICATE OF INDEPENDENT BID

DETERMINATION

I, the undersigned, in submitting the accompanying

bid…………………………………………………………,

in response to the invitation for the bid made by the Department Of Health, do hereby make the following

statements that I certify to be true and complete in every respect:

certify, on behalf

that

1. I have read and I understand the contents of this

Certificate;

2. I understand that the accompanying bid will be disqualified if this Certificate is found not

true and complete in every

respect;

3. I am authorised by the bidder to sign this Certificate, and to submit the accompanying bid,

behalf of the

bidder;

4. Each person whose signature appears on the accompanying bid has been authorised

the

bidder to determine the terms of, and to sign the bid, on behalf of the

bidder;

SBD9

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 24

HP10-2021BIO

SUPPLY AND DELIVERY

OF SMALL BIOLOGICAL

PREPARATIONS



5. For the purposes of this Certificate and the accompanying bid, I understand that the

word

“competitor” shall include any individual or organization, other than the bidder, whether or

not

affiliated with the bidder,

who:

a. has been requested to submit a bid in response to this bid

invitation;

b. could potentially submit a bid in response to this bid invitation, based on

their

qualifications, abilities or experience;

and

c. provides the same goods and services as the bidder and/or is in the same line of

business

as the

bidder.

The bidder has arrived at the accompanying bid independently from, and without

consultation,

communication, agreement or arrangement with any competitor. However

communication

between partners in a joint venture or consortium³ will not be construed as collusive

bidding.

7. In particular, without limiting the generality of paragraphs 6 above, there has been no consultation,

communication, agreement or arrangement with any competitor regarding:

a. prices;

b. geographical area where product or service will be rendered (market allocation)

c. methods, factors or formulas used to calculate prices;

d. the intention or decision to submit or not to submit, a bid;

e. the submission of a bid which does not meet the specifications and conditions of the bid; or

f. bidding with the intention not to win the bid.

8. In addition, there have been no consultations, communications, agreements or arrangements with

any competitor regarding the quality, quantity, specifications and conditions or delivery particulars

of the products or services to which this bid invitation relates.

9. The terms of the accom panying bid have not been, and will n ot be, disclo sed by the bidder,

directly or indirectly, to any competito r, prior to the date and time of the official bid openi ng or of

the awarding of the contract.

10. I am aware that, in addition and without prejudice to any other remedy provided to combat any

restrictive practices related to bids and contracts, bids that are suspicious will be reported to the

Competition Commission for investigation and po ssible imposition of administ rative penalties in

terms of section 59 of the Competition Act No 89 of 1998 and or may be reported to the National

Prosecuting Authority (NPA) for criminal investigation and or may be restri cted from conducting

business with the public sector for a period not exceeding ten (10) years in terms of the Prevention

and Combating of Corrupt Activities Act No 12 of 2004 or any other applicable legislation.

Name of Bidder

Full Name

Postion

Signature

Date

³ Joint venture or Consortium means an association of persons for the purpose of

combining their expertise, property, capital, efforts, skill and knowledge in an activity

for the execution of a contract.

SBD9

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 25



AUTHORISATION DECLARATION (PBD1)

NAME OF THE BIDDER

Are you sourcing the products from a third party? Yes No

* If you have answered YES to the above question, please provide full details in the table below of

the third party (ies) from whom you are sourcing the products.

1. Declaration by the bidder where the bidder is sourcing the products from a third party.

The bidder hereby declares the following:-

1.1 The bidder is sourcing the products listed in the PBD1.1 attached, from a third party in

order to comply with the terms and conditions of the bid.

1.2 The bidder has informed the third party of the terms and conditions of the bid and the third party

is acquainted with the said terms and the description of the products listed in the PBD1.1.

1.3 The bidder has received the attached, unconditional written undertaking from the third party

to supply the products listed in the PBD1.1 in accordance with the terms and conditions of the

bid document for the duration of the contract. A template has been attached (PBD1.2) that is to

be used for

e purpose of the third party undertaking.

1.4 The bidder confirms that all f inancial and supply arrangements for the products have been

mutually agreed upon between the bidder and the third party.

2. The bidder declares that the information contained herein is true and correct.

3. The bidder acknowledges that the Department of Health reserves the right to verify the

information contained therein and if found to be false or incorrect may invoke any remedies available

to it in the bid documents.

Signed at

on the

day of

Full Names

Designation

Signature

PBD1

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 26



List of the products offered sourced from third party

Bid Item

Brand

Name

Name of the company

from

where the

products will

be sourced

Address and contact details of the

company

from

where the products will be

sourced

PBD1.1

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 27



List of the products offered sourced from third

party -

continued

Bid Item

Brand

Name

Name of the company

from

where the

products will

be sourced

Address and contact details of the

company

from

where the products will be

sourced

(Should the table provided not be sufficient for all the items offered, please provide additional information as an attachment and it must be properly

referenced to

this document)

PBD1.1

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 28



Template for unconditional written undertaking from the third party

Note:

The authorisation letter must be on the official letterhead of the third party

A separate letter must be included for each third party

The authorisation letter must be addressed to the Bidding Company

Name of Bidding Company: ________________________________________

Address of Bidding Company: ______________________________________

_______________________________________________________________

Attention: _______________________________________________________

Dear Sir/Madam

AUTHORISATION

LETTER:

CONTRACT

NO _______________

We, (Name of Third Party)

hereby authorise you, (Name of Company) to include the

products listed below in your bid submission for the abovementioned contract.

We confirm that we have firm supply arrangements in place, and have familiarised

ourselves with the

item

descriptions, specifications and bid conditions relating to item/s listed below.

Item no. Description of product Brand name

(Should the table provided not be sufficient for all the items offered, please provide additional

information as an attachment and it must be properly referenced to this document)

Yours faithfully,

Signature of the Third Party: Date:

PBD1.2

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 29

PBD5 DECLARATION OF COMPLIANCE WITH GOOD MANUFACTURING

PRACTICE (GMP)

To be signed by the Chief Executive Officer of the Company in terms of this bid.

I,………………………………………………………………………………………………………

(Full name) being the Chief Executive Officer

Of……………………………………………………………………………………………………

(Organisation name) hereby certify that to the best of my knowledge all reasonable steps have

been taken to ensure that:

a) There are no outstanding or impending GMP or legal matters that may have a material

impact on the Company’s ability to perform in terms of this contract.

b) In terms of this declaration, I undertake to inform the Department of Health at first knowledge

of any circumstances that may result in interrupted supply.

c) (Organisation name).................................................................. has complied with all the

legal requirements as stipulated in terms of Medicines and Related Substances Act 101 of

1965, as amended,: for such products offered.

…………………………………………………………………………………………

Full Name of Chief Executive Officer

…………………………………………………………………………………………

Full Identity Number/or equivalent of the Chief Executive Officer

…………………………………………………………………………………………

Signature of Chief Executive Officer

…………………………………………………………………………………………

Signature of Witness

…………………………………………………………………………………………………….

Signed at Date

PBD5

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 30

 PBD 8

PBD 8: DECLARATION OF COMPLIANCE WITH THE SPECIAL REQUIREMENTS

AND CONDITIONS OF CONTRACT

To be signed by the Chief Executive Officer of the Company in terms of this bid.

I,…………………………………………………………………………………………… (Full name)

being the Chief Executive Officer

of…………………………………………………………………………………………(Organisation name)

hereby declare that to the best of my knowledge all reasonable steps have been taken to ensure

that:

a) (Organisation name)............................................................................................. has complied

with all the legal requirements as provided in the Medicines and Related Substances Act

101 of 1965, as amended, for such products offered;

b) There are no outstanding or impending matters (including GMP or legal) that may have a

material impact on the Company’s ability to perform in terms of this contract

In terms of this declaration, I undertake to inform the Department of Health at first knowledge of any

circumstances that may result in interrupted supply of product if the contract is awarded.

I further declare that

……………………………………………………………………………………(Organisation name)

will comply with the requirements and conditions as stipulated in the Special Requirements and

Conditions of Contract

…………………………………………………………………………………………

Full Name of Chief Executive Officer

…………………………………………………………………………………………

Full Identity Number/or equivalent of the Chief Executive Officer

…………………………………………………………………………………………

Signature of Chief Executive Officer

…………………………………………………………………………………………

Signature of Witness

Date Signed ....................................................... at ...........................................



2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 31



Definition of fields in Bid Response Document, to be read in conjunction with the Special

Requirements and

Conditions of Contract

Field Name Field Definition

FIELDS WHICH ARE PRE-FILLED AND MAY NOT BE ALTERED

Item Number The relevant item number which will be used throughout the contract period.

Each item number is linked to a specification

Item Specification The specification of the item for which a call for bids has been issued, as linked to

the item number.

Unit The unit of measure for the specification. This determines how the estimates are

expressed and how the price should be quoted. This may be one injection or one

pack of 100 tablets, etc.

Estimate The estimated quantities associated with the item number and specification,

for the full contract period. Estimates are expressed in unit packs.

FIELDS WHICH ARE TO BE COMPLETED BY THE BIDDER FOR ALL ITEMS ON WHICH BIDS ARE

OFFERED

Regis

ered legal

name of bidder

The full, regis

ered, legal name of

he bidder, as on VAT regis

ration certifica

eand

Medicine Re

ration Certifica

lican

Quantity for full period

The volume of the item (expressed in units) which the bidder can provide

durin

the com

lete

eriod of the tender

Delivered price in ZAR

Final price offered by a bidder for an item number as per specification, which

includes VAT and deliver

. Must be the

rice fo

a unit as advertised.

Registered Product Name Brand name. Must correspond with Medicine Registration Certificate (1) GW12/7

Conforms to specification? Confirm whether or not the product on offer conforms exactly to the Item

Specification.

If NO: De

ail devia

ion

from specification.

Detail exact deviation from Item Specification, as per registration of product on

offer.

Product Registration

Number

As per Medicine Registration Certificate Certificate(2) GW12/7

License to Manufac

ure

Medicines:

License Number , Expiry

date

As per License to Manufacture Medicines – this must correspond with the

document submitted

Pack Size Offered: Unit

pack

Single unit offered according to specification in numbers e.g. each (1) This must

correspond with the delivered price.

Pack Size Offered: Shelf

Pack

Number of Unit Packs within the smallest wrap (e.g. 10 ampoules)

Standard units in: Shipper

Pack

Number of unit packs in a shipper / bulk box

Lead-Time Interval between receipt of an order until delivery at facility which placed the order.

Must not exceed 14 calendar days.

Initial lead time Interval between award of the tender and ability to fill an order. This must not

exceed 75 calendar days.

Minimum Order Quantity The lowest acceptable quantity for a given purchase order.

Batch size for

he bid

item, in number of

acks

Batch size, expressed in number of units

Monthly batch capacity

Monthly batch capacity that will be assigned for the bid item for the duration of the

contract expressed in number of batches.

Technical amendment

required?

Do you require a technical amendment to perform according to the conditions of

your bid Y/N

If YES: Provide details Provide all relevant details (can be provided in a covering letter)

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 32



Definition of fields in Bid Response Document, to be read in conjunction with the Special

Requirements and

Conditions of Contract

Field Name Field Definition

EAN 13 Barcode for Unit

Pack

Provide Number

EAN 13 Barcode for Shelf

Pack

Provide Number

ITF14 Barcode for Shipper

Pack

Provide Number

2D Barcode or Similar Provide Number

NAPPI Code Provide Code

Manufacturer As per MCC Certificate (8) GW12/7 – List all sources

SEP Price

The most recently approved Single Exit Price expressed in corresponding unit to

bid

Are any of the listed

manufacturers

etc. 3rd parties to the

bidder?

Y/N

If YES - complete PBD1 and include letter(s) of authorisation as applicable

API Source Full Site Name

(x3)

Full name of API source, including company name and site – List all sources

API Source Full Address Full physical address of API source – List all sources

API Source Country Country of API source – List all sources

API Source Contact Listed contact information

PRICING COMPONENT BREAKDOWN

Note: VAT must be apportioned equally across all components. Please see pricing section in Special Conditions

Percentage of Delivered

Price attributable to API

The percentage of the Delivered Price associated with API, (the therapeutically

active component of the medicine). Should an item be imported as finished

product, the component may be reflected as part of formulation cost.

Imported (API) Portion of API component attributable to imported expenditure

Percentage of Delivered

Price attributable to

Formulation

The percentage of the delivered price associated with Formulation, (includes all

operations in the process of which different chemical substances, including the

API, are combined to produce a final medicinal product), includes material,

processing, production, quality assurance and related controls.

Local (Formulation) Portion of Formulation component attributable to local expenditure

Imported (Formulation) Portion of Formulation component attributable to imported expenditure

Packaging The percentage of the Delivered Price associated with Packaging, where

packaging includes all operations in the process of packaging medicine into

primary and/or secondary packaging, packaging material and labels.

Local (Packaging) Portion of Packaging component attributable to local expenditure

Imported (Packaging) Portion of Packaging component attributable to imported expenditure

Logistics Percentage of delivered price associated with logistics, where logistics includes

all operations, taking place within the Republic of South Africa, relating to the

storage, distribution and transportation of medicine to the healthcare facility or

pharmaceutical depot.

Gross Margin Percentage of delivered price not associated with API, Formulation, Packaging,

or Logistics.

Currency Primary currency in which manufacturer trades for imported components



2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 33

THE NATIONAL TREASURY

Republic of South Africa

_____________________________________________________________________

GOVERNMENT PROCUREMENT:

GENERAL CONDITIONS OF CONTRACT

July 2010

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 34

GOVERNMENT PROCUREMENT

GENERAL CONDITIONS OF CONTRACT

July 2010

NOTES

The purpose of this document is to:

(i) Draw special attention to certain general conditions

applicable to government bids, contracts and orders; and

(ii) To ensure that clients be familiar with regard to the rights

and obligations of all parties involved in doing business

with government.

In this document words in the singular also mean in the plural

and vice versa and words in the masculine also mean in the

feminine and neuter.

• The General Conditions of Contract will form part of

all bid documents and may not be amended.

• Special Conditions of Contract (SCC) relevant to a specific

bid, should be compiled separately for every bid (if

(applicable) and will supplement the General Conditions

of Contract. Whenever there is a conflict, the provisions

in the SCC shall prevail.

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 35

TABLE OF CLAUSES

1. Definitions

2. Application

3. General

4. Standards

5. Use of contract documents and information; inspection

6. Patent rights

7. Performance security

8. Inspections, tests and analysis

9. Packing

10. Delivery and documents

11. Insurance

12. Transportation

13. Incidental services

14. Spare parts

15. Warranty

16. Payment

17. Prices

18. Contract amendments

19. Assignment

20. Subcontracts

21. Delays in the supplier’s performance

22. Penalties

23. Termination for default

24. Dumping and countervailing duties

25. Force Majeure

26. Termination for insolvency

27. Settlement of disputes

28. Limitation of liability

29. Governing language

30. Applicable law

31. Notices

32. Taxes and duties

33. National Industrial Participation Programme (NIPP)

34. Prohibition of restrictive practices

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General Conditions of Contract

1. Definitions

1. The following terms shall be interpreted as indicated:

1.1 “Closing time” means the date and hour specified in the bidding

documents for the receipt of bids.

1.2 “Contract” means the written agreement entered into between the

purchaser and the supplier, as recorded in the contract form signed by

the parties, including all attachments and appendices thereto and all

documents incorporated by reference therein.

1.3 “Contract price” means the price payable to the supplier under the

contract for the full and proper performance of his contractual

obligations.

1.4 “Corrupt practice” means the offering, giving, receiving, or soliciting

of any thing of value to influence the action of a public official in the

procurement process or in contract execution.

1.5 "Countervailing duties" are imposed in cases where an enterprise

abroad is subsidized by its government and encouraged to market its

products internationally.

1.6 “Country of origin” means the place where the goods were mined,

grown or produced or from which the services are supplied. Goods are

produced when, through manufacturing, processing or substantial and

major assembly of components, a commercially recognized new

product results that is substantially different in basic characteristics or

in purpose or utility from its components.

1.7 “Day” means calendar day.

1.8 “Delivery” means delivery in compliance of the conditions of the

contract or order.

1.9 “Delivery ex stock” means immediate delivery directly from stock

actually on hand.

1.10 “Delivery into consignees store or to his site” means delivered and

unloaded in the specified store or depot or on the specified site in

compliance with the conditions of the contract or order, the supplier

bearing all risks and charges involved until the supplies are so

delivered and a valid receipt is obtained.

1.11 "Dumping" occurs when a private enterprise abroad market its goods

on own initiative in the RSA at lower prices than that of the country of

origin and which have the potential to harm the local industries in the

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RSA.

1.12 ”Force majeure” means an event beyond the control of the supplier and

not involving the supplier’s fault or negligence and not foreseeable.

Such events may include, but is not restricted to, acts of the purchaser

in its sovereign capacity, wars or revolutions, fires, floods, epidemics,

quarantine restrictions and freight embargoes.

1.13 “Fraudulent practice” means a misrepresentation of facts in order to

influence a procurement process or the execution of a contract to the

detriment of any bidder, and includes collusive practice among bidders

(prior to or after bid submission) designed to establish bid prices at

artificial non-competitive levels and to deprive the bidder of the

benefits of free and open competition.

1.14 “GCC” means the General Conditions of Contract.

1.15 “Goods” means all of the equipment, machinery, and/or other materials

that the supplier is required to supply to the purchaser under the

contract.

1.16 “Imported content” means that portion of the bidding price represented

by the cost of components, parts or materials which have been or are

still to be imported (whether by the supplier or his subcontractors) and

which costs are inclusive of the costs abroad, plus freight and other

direct importation costs such as landing costs, dock dues, import duty,

sales duty or other similar tax or duty at the South African place of

entry as well as transportation and handling charges to the factory in

the Republic where the supplies covered by the bid will be

manufactured.

1.17 “Local content” means that portion of the bidding price which is not

included in the imported content provided that local manufacture does

take place.

1.18 “Manufacture” means the production of products in a factory using

labour, materials, components and machinery and includes other

related value-adding activities.

1.19 “Order” means an official written order issued for the supply of goods

or works or the rendering of a service.

1.20 “Project site,” where applicable, means the place indicated in bidding

documents.

1.21 “Purchaser” means the organization purchasing the goods.

1.22 “Republic” means the Republic of South Africa.

1.23 “SCC” means the Special Conditions of Contract.

1.24 “Services” means those functional services ancillary to the supply of

the goods, such as transportation and any other incidental services,

such as installation, commissioning, provision of technical assistance,

training, cat

ering, gardening, security, maintenance and other such

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obligations of the supplier covered under the contract.

1.25 “Written” or “in writing” means handwritten in ink or any form of

electronic or mechanical writing.

2. Application

2.1 These general conditions are applicable to all bids, contracts and orders

including bids for functional and professional services, sales, hiring,

letting and the granting or acquiring of rights, but excluding

immovable property, unless otherwise indicated in the bidding

documents.

2.2 Where applicable, special conditions of contract are also laid down to

cover specific supplies, services or works.

2.3 Where such special conditions of contract are in conflict with these

general conditions, the special conditions shall apply.

3. General

3.1 Unless otherwise indicated in the bidding documents, the purchaser

shall not be liable for any expense incurred in the preparation and

submission of a bid. Where applicable a non-refundable fee for

documents may be charged.

3.2 With certain exceptions, invitations to bid are only published in the

Government Tender Bulletin. The Government Tender Bulletin may be

obtained directly from the Government Printer, Private Bag X85,

Pretoria 0001, or accessed electronically from www.treasury.gov.za

4. Standards

4.1 The goods supplied shall conform to the standards mentioned in the

bidding documents and specifications.

5. Use of

contract

documents

and

information;

inspection.

5.1 The supplier shall not, without the purchaser’s prior written consent,

disclose the contract, or any provision thereof, or any specification,

plan, drawing, pattern, sample, or information furnished by or on

behalf of the purchaser in connection therewith, to any person other

than a person employed by the supplier in the performance of the

contract. Disclosure to any such employed person shall be made in

confidence and shall extend only so far as may be necessary for

purposes of such performance.

5.2 The supplier shall not, without the purchaser’s prior written consent,

make use of any document or information mentioned in GCC clause

5.1 except for purposes of performing the contract.

5.3 Any document, other than the contract itself mentioned in GCC clause

5.1 shall remain the property of the purchaser and shall be returned (all

copies) to the purchaser on completion of the supplier’s performance

under the contract if so required by the purchaser.

5.4 The supplier shall permit the purchaser to inspect the supplier’s records

relating to the performance of the supplier and to have them audited by

auditors appointed by the purchaser, if so required by the purchaser.

6. Patent rights

6.1 The supplier shall indemnify the purchaser against all third-party

claims of infringement of patent, trademark, or industrial de

sign rights

arising from use of the goods or any part thereof by the purchaser.

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7. Performance

security

7.1 Within thirty (30) days of receipt of the notification of contract award,

the successful bidder shall furnish to the purchaser the performance

security of the amount specified in SCC.

7.2 The proceeds of the performance security shall be payable to the

purchaser as compensation for any loss resulting from the supplier’s

failure to complete his obligations under the contract.

7.3 The performance security shall be denominated in the currency of the

contract, or in a freely convertible currency acceptable to the purchaser

and shall be in one of the following forms:

(a) a bank guarantee or an irrevocable letter of credit issued by a

reputable bank located in the purchaser’s country or abroad,

acceptable to the purchaser, in the form provided in the

bidding documents or another form acceptable to the

purchaser; or

(b) a cashier’s or certified cheque

7.4 The performance security will be discharged by the purchaser and

returned to the supplier not later than thirty (30) days following the

date of completion of the supplier’s performance obligations under the

contract, including any warranty obligations, unless otherwise

specified in SCC.

8. Inspections,

tests and

analyses

8.1 All pre-bidding testing will be for th

e account of the bidder.

8.2 If it is a bid condition that supplies to be produced or services to be

rendered should at any stage during production or execution or on

completion be subject to inspection, the premises of the bidder or

contractor shall be open, at all reasonable hours, for inspection by a

representative of the Department or an organization acting on behalf of

the Department.

8.3 If there are no inspection requirements indicated in the bidding

documents and no mention is made in the contract, but during the

contract period it is decided that inspections shall be carried out, the

purchaser shall itself make the necessary arrangements, including

payment arrangements with the testing authority concerned.

8.4 If the inspections, tests and analyses referred to in clauses 8.2 and 8.3

show the supplies to be in accordance with the contract requirements,

the cost of the inspections, tests and analyses shall be defrayed by the

purchaser.

8.5 Where the supplies or services referred to in clauses 8.2 and 8.3 do not

comply with the contract requirements, irrespective of whether such

supplies or services are accepted or not, the cost in connection with

these inspections, tests or analyses shall be defrayed by the supplier.

8.6 Supplies and services which are referred to in clauses 8.2 and 8.3 and

which do not comply with the contract requirements may be rejected.

8.7

Any contract supplies may on or after

delivery be inspected, tested or

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analyzed and may be rejected if found not to comply with the

requirements of the contract. Such rejected supplies shall be held at the

cost and risk of the supplier who shall, when called upon, remove them

immediately at his own cost and forthwith substitute them with

supplies which do comply with the requirements of the contract.

Failing such removal the rejected supplies shall be returned at the

suppliers cost and risk. Should the supplier fail to provide the

substitute supplies forthwith, the purchaser may, without giving the

supplier further opportunity to substitute the rejected supplies,

purchase such supplies as may be necessary at the expense of the

supplier.

8.8 The provisions of clauses 8.4 to 8.7 shall not prejudice the right of the

purchaser to cancel the contract on account of a breach of the

conditions thereof, or to act in terms of Clause 23 of GCC.

9. Packing

9.1 The supplier shall provide such packing of the goods as is required to

prevent their damage or deterioration during transit to their final

destination, as indicated in the contract. The packing shall be

sufficient to withstand, without limitation, rough handling during

transit and exposure to extreme temperatures, salt and precipitation

during transit, and open storage. Packing, case size and weights shall

take into consideration, where appropriate, the remoteness of the

goods’ final destination and the absence of heavy handling facilities at

all points in transit.

9.2 The packing, marking, and documentation within and outside the

packages shall comply strictly with such special requirements as shall

be expressly provided for in the contract, including additional

requirements, if any, specified in SCC, and in any subsequent

instructions ordered by the purchaser.

10. Delivery

and documents

10.1 Delivery of the goods shall be made by th

e supplier in accordance with

the terms specified in the contract. The details of shipping and/or other

documents to be furnished by the supplier are specified in SCC.

10.2 Documents to be submitted by the supplier are specified in SCC.

11. Insurance

11.1 The goods supplied under the contract shall be fully insured in a freely

convertible currency against loss or damage incidental to manufacture

or acquisition, transportation, storage and delivery in the manner

specified in the SCC.

12. Transportation

12.1 Should a price other than an all-inclusive delivered price be required,

this shall be specified in the SCC.

13. Incidental

services

13.1 The supplier may be required to provide any or all of the following

services, including additional services, if any, specified in SCC:

(a) performance or supervision of on-

site assembly and/or

commissioning of the supplied goods;

(b) furnishing of tools required for assembly and/or maintenance

of the supplied goods;

for each appropriate unit of the supplied goods;

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(d) performance or supervision or maintenance and/or repair of

the supplied goods, for a period of time agreed by the parties,

provided that this service shall not relieve the supplier of any

warranty obligations under this contract; and

(e) training of the purchaser’s personnel, at the supplier’s plant

and/or on-site, in assembly, start-up, operation,

maintenance, and/or repair of the supplied goods.

13.2 Prices charged by the supplier for incidental services, if not included in

the contract price for the goods, shall be agreed upon in advance by the

parties and shall not exceed the prevailing rates charged to other

parties by the supplier for similar services.

14. Spare parts

14.1 As specified in SCC, the supplier may be required to provide any or all

of the following materials, notifications, and information pe

rtaining to

spare parts manufactured or distributed by the supplier:

(a) such spare parts as the purchaser may elect to purchase from the

supplier, provided that this election shall not relieve the supplier

of any warranty obligations under the contract; and

(b) in the event of termination of production of the spare parts:

(i) Advance notification to the purchaser of the pending

termination, in sufficient time to permit the purchaser to

procure needed requirements; and

(ii) following such termination, furnishing at no cost to the

purchaser, the blueprints, drawings, and specifications of the

spare parts, if requested.

15. Warranty

15.1 The supplier warrants that the goods supplied under the contract are

new, unused, of the most recent or current models, and that they

incorporate all recent improvements in design and materials unless

provided otherwise in the contract. The supplier further warrants that

all goods supplied under this contract shall have no defect, arising from

design, materials, or workmanship (except when the design and/or

material is required by the purchaser’s specifications) or from any act

or omission of the supplier, that may develop under normal use of the

supplied goods in the conditions prevailing in the country of final

destination.

15.2 This warranty shall remain valid for twelve (12) months after the

goods, or any portion thereof as the case may be, have been delivered

to and accepted at the final destination indicated in the contract, or for

eighteen (18) months after the date of shipment from the port or place

of loading in the source country, whichever period concludes earlier,

unless specified otherwise in SCC.

15.3 The purchaser shall promptly notify the supplier in writing of any

claims arising under this warranty.

15.4 Upon receipt of such notice, the supplier shall, within the period

specified in SCC and with all reasonable speed, repair or replace the

defective goods or parts thereof, without costs to the purchaser.

15.5 If the supplier, having been notified, fails to remedy the defect(s)

within the p

eriod specified in SCC, the purchaser may proceed to take

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such remedial action as may be necessary, at the supplier’s risk and

expense and without prejudice to any other rights which the purchaser

may have against the supplier under the contract.

16. Payment

16.1 The method and conditions of payment to be made to the supplier

under this contract shall be specified in SCC.

16.2 The supplier shall furnish the purchaser with an invoice accompanied

by a copy of the delivery note and upon fulfillment of other obligations

stipulated in the contract.

16.3 Payments shall be made promptly by the purchaser, but in no case later

than thirty (30) days after submission of an invoice or claim by the

supplier.

16.4 Payment will be made in Rand unless otherwise stipulated in SCC.

17. Prices

17.1 Prices charged by the supplier for goods delivered and services

performed under the contract shall not vary from the prices quoted by

the supplier in his bid, with the exception of any price adjustments

authorized in SCC or in the purchaser’s request for bid validity

extension, as the case may be.

18. Contract

amendments

18.1 No variation in or modification of the terms of the contract shall be

made except by written amendment signed by the parties concerned.

19. Assignment

19.1 The supplier shall not assign, in whole or in part, its obligations to

perform under the contract, except with the purchaser’s prior written

consent.

20. Subcontracts

20.1 The supplier shall notify the purchaser in writing of all subcontracts

awarded under this contracts if not already specified in the bid. Such

notification, in the original bid or later, shall not relieve the supplier

from any liability or obligation under the contract.

21. Delays in the

supplier’s

performance

21.1 Delivery of the goods and performance of services shall be made by

the supplier in accordance with the time schedule prescribed by the

purchaser in the contract.

21.2 If at any time during performance of the contract, the supplier or its

subcontractor(s) should encounter conditions impeding timely delivery

of the goods and performance of services, the supplier shall promptly

notify the purchaser in writing of the fact of the delay, its likely

duration and its cause(s). As soon as practicable after receipt of the

supplier’s notice, the purchaser shall evaluate the situation and may at

his discretion extend the supplier’s time for performance, with or

without the imposition of penalties, in which case the extension shall

be ratified by the parties by amendment of contract.

21.3 No provision in a contract shall be deemed to prohibit the obtaining of

supplies or services from a national department, provincial department,

or a local authority.

21.4 The right is reserved to procure outside of the contract small quantities

or to have minor essential services executed if an emergency arises, the

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supplier’s point of supply is not situated at or near the place where the

supplies are required, or the supplier’s services are not readily

available.

21.5 Except as provided under GCC Clause 25, a delay by the supplier in

the performance of its delivery obligations shall render the supplier

liable to the imposition of penalties, pursuant to GCC Clause 22,

unless an extension of time is agreed upon pursuant to GCC Clause

21.2 without the application of penalties.

21.6 Upon any delay beyond the delivery period in the case of a supplies

contract, the purchaser shall, without canceling the contract, be entitled

to purchase supplies of a similar quality and up to the same quantity in

substitution of the goods not supplied in conformity with the contract

and to return any goods delivered later at the supplier’s expense and

risk, or to cancel the contract and buy such goods as may be required

to complete the contract and without prejudice to his other rights, be

entitled to claim damages from the supplier.

22. Penalties

22.1 Subject to GCC Clause 25, if the supplier fails to deliver any or all of

the goods or to perform the services within the period(s) sp

ecified in

the contract, the purchaser shall, without prejudice to its other remedies

under the contract, deduct from the contract price, as a penalty, a sum

calculated on the delivered price of the delayed goods or unperformed

services using the current prime interest rate calculated for each day of

the delay until actual delivery or performance. The purchaser may also

consider termination of the contract pursuant to GCC Clause 23.

23. Termination

for default

23.1 The purchaser, without prejudice to any other remedy for breach of

contract, by written notice of default sent to the supplier, may

terminate this contract in whole or in part:

(a)

if the supplier fails to deliver any or all of the goods within

the period(s) specified in the contract, or within any

extension thereof granted by the purchaser pursuant to GCC

Clause 21.2;

(b) if the Supplier fails to perform any other obligation(s) under

the contract; or

engaged in corrupt or fraudulent practices in competing for

or in executing the contract.

23.2 In the event the purchaser terminates the contract in whole or in part,

the purchaser may procure, upon such terms and in such manner as it

deems appropriate, goods, works or services similar to those undelivered,

and the supplier shall be liable to the purchaser for any excess costs for

such similar goods, works or services. However, the supplier shall

continue performance of the contract to the extent not terminated.

23.3 Where the purchaser terminates the contract in whole or in part, the

purchaser may decide to impose a restriction penalty on the supplier by

prohibiting such supplier from doing business with the public sector for a

period not exceeding 10 years.

23.4

If a purchaser intends imposing a restriction on a s

upplier or any

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person associated with the supplier, the supplier will be allowed a time

period of not more than fourteen (14) days to provide reasons why the

envisaged restriction should not be imposed. Should the supplier fail to

respond within the stipulated fourteen (14) days the purchaser may regard

the intended penalty as not objected against and may impose it on the

supplier.

23.5 Any restriction imposed on any person by the Accounting Officer /

Authority will, at the discretion of the Accounting Officer / Authority,

also be applicable to any other enterprise or any partner, manager,

director or other person who wholly or partly exercises or exercised or

may exercise control over the enterprise of the first-mentioned person,

and with which enterprise or person the first-mentioned person, is or was

in the opinion of the Accounting Officer / Authority actively associated.

23.6 If a restriction is imposed, the purchaser must, within five (5) working

days of such imposition, furnish the National Treasury, with the

following information:

(i) the name and address of the supplier and / or person restricted by the

purchaser;

(ii) the date of commencement of the restriction

(iii) the period of restriction; and

(iv) the reasons for the restriction.

These details will be loaded in the National Treasury’s central database

of suppliers or persons prohibited from doing business with the public

sector.

23.7 If a court of law convicts a person of an offence as contemplated in

sections 12 or 13 of the Prevention and Combating of Corrupt Activities

Act, No. 12 of 2004, the court may also rule that such person’s name be

endorsed on the Register for Tender Defaulters. When a person’s name

has been endorsed on the Register, the person will be prohibited from

doing business with the public sector for a period not less than five years

and not more than 10 years. The National Treasury is empowered to

determine the period of restriction and each case will be dealt with on its

own merits. According to section 32 of the Act the Register must be

open to the public. The Register can be perused on the National Treasury

website.

24. Anti-dumping

and countervailing

duties and rights

24.1 When, after the da

te of bid, provisional payments are required, or anti-

dumping or countervailing duties are imposed, or the amount of a

provisional payment or anti-dumping or countervailing right is

increased in respect of any dumped or subsidized import, the State is

not liable for any amount so required or imposed, or for the amount of

any such increase. When, after the said date, such a provisional

payment is no longer required or any such anti-dumping or

countervailing right is abolished, or where the amount of such

provisional payment or any such right is reduced, any such favourable

difference shall on demand be paid forthwith by the contractor to the

State or the State may deduct such amounts from moneys (if any)

which may otherwise be due to the contractor in regard to supplies or

services which he delivered or rendered, or is to deliver or render in

terms of the con

tract or any other contract or any other amount which

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may be due to him

25. Force

Majeure

25.1 Notwithstanding the provisions of GCC Clauses 22 and 23, the

supplier shall not be liable for forfeiture of its performance security,

damages, or termination for default if and to the extent that his delay in

performance or other failure to perform his obligations under the

contract is the result of an event of force majeure.

25.2 If a force majeure situation arises, the supplier shall promptly notify

the pu

rchaser in writing of such condition and the cause thereof.

Unless otherwise directed by the purchaser in writing, the supplier

shall continue to perform its obligations under the contract as far as is

reasonably practical, and shall seek all reasonable alternative means for

performance not prevented by the force majeure event.

26. Termination

for insolvency

26.1 The purchaser may at any time terminate the contract by giving written

notice to the supplier if the supplier becomes bankrupt or otherwise

insolvent. In this event, termination will be without compensation to

the supplier, provided that such termination will not prejudice or affect

any right of action or remedy which has accrued or will accrue

thereafter to the purchaser.

27. Settlement of

Disputes

28. Limitation of

liability

27.1 If any dispute or difference of any kind whatsoever arises between the

purchaser and the supplier in connection with or arising out of the

contract, the parties shall make every effort to resolve amicably such

dispute or difference by mutual consultation.

27.2 If, after thirty (30) days, the parties have failed to resolve their dispute

or difference by such mutual consultation, then either the purchaser or

the supplier may give notice to the other party of his intention to

commence with mediation. No mediation in respect of this matter may

be commenced unless such notice is given to the other party.

27.3 Should it not be possible to settle a dispute by means of mediation, it

may be settled in a South African court of law.

27.4 Mediation proceedings shall be conducted in accordance with the rules

of procedure specified in the SCC.

27.5 Notwithstanding any reference to mediation and/or court proceedings

herein,

(a) the parties shall continue to perform their respective obligations

under the contract unless they otherwise agree; and

(b) the purchaser shall pay the supplier any monies due the supplier.

28.1 Except in cases of criminal negligence or willful misconduct, and in

the case of infringement pursuant to Clause 6;

(a) the supplier shall not be liable to the purchaser, whether in

contract, tort, or otherwise, for any indirect or consequential loss

or damage, loss of use, loss of production, or loss of profits or

interest costs, provided that this exclusion shall not apply to any

obligation of the supplier to pay penalties and/or damages to the

purchaser; and

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(b) the aggregate liability of the supplier to the purchaser, whether

under the contract, in tort or otherwise, shall not exceed the total

contract price, provided that this limitation shall not apply to the

cost of repairing or replacing defective equipment.

29. Governing

language

29.1 The contract shall be written in English. All correspondence and other

documents pertaining to the contract that is exchanged by the parties

shall also be written in English.

30. Applicable

law

30.1 The contract shall be interpreted in accordance with South African

laws, unless otherwise specified in SCC.

31. Notices

31.1 Every written acceptance of a bid shall be posted to the supplier

concerned by registered or certified mail and any other notice to him

shall be posted by ordinary mail to the address furnished in his bid or

to the address notified later by him in writing and such posting shall be

deemed to be proper service of such notice

31.2 The time mentioned in the contract documents for performing any act

after such aforesaid notice has been given, shall be reckoned from the

date of posting of such notice.

32. Taxes and

duties

32.1 A foreign supplier shall be entirely responsible for all taxes, stamp

duties, license fees, and other such levies imposed outside the

purchaser’s country.

32.2 A local supplier shall be entirely responsible for all taxes, duties,

license fees, etc., incurred until delivery of the contracted goods to

the purchaser.

32.3 No contract shall be concluded with any bidder whose tax matters are

not in order. Prior to the award of a bid the Department must be in

possession of a tax clearance certificate, submitte

d by the bidder.

This certificate must be an original issued by the South African

Revenue Services.

33. National

Industrial

Participation (NIP)

Programme

34 Prohibition of

Restrictive practices

33.1 The NIP Programme administered by the Department of Trade and

Industry shall be applicable to all contracts that are subject to the

NIP obligation.

In terms of section 4 (1) (b) (iii) of the Competition Act No. 89 of 1998, as

amended, an agreement between, or concerted practice by, firms, or a

decision by an association of firms, is prohibited if it is between parties in a

horizontal relationship and if a bidder (s) is / are or a contractor(s) was /

were involved in collusive bidding (or bid rigging).

34.2 If a bidder(s) or contractor(s), based on reasonable grounds or evidence

obtained by the purchaser, has / have engaged in the restrictive practice

referred to above, the purchaser may refer the matter to the Competition

Commission for investigation and possible imposition of administrative

penalties as contemplated in the Competition Act No. 89 of 1998.

34.3 If a bidder(s) or contractor(s), has / have been found guilty by the

Competition Commission of the restrictive practice referred to above, the

purchaser may, in addition and without prejudice to any other remedy

provided for, invalidate the bid(s) for such item(s) offered, and / or

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SPECIAL REQUIREMENTS AND CONDITIONS OF CONTRACT

HP10-2021BIO

SUPPLY AND DELIVERY OF

BIOLOGICAL PREPARATIONS TO THE DEPARTMENT

OF HEALTH FOR THE PERIOD 01 JANUARY 2021 TO 31 DECEMBER 2022

BID VALIDITY PERIOD: 120 DAYS

CLOSING DATE AND TIME OF BID:

8 JUNE 2020 AT 11:00

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Special Requirements and Conditions of Contract: HP10-2021BIO



Page 2 of 34

TABLE OF CONTENTS

ABBREVIATIONS ......................................................................................................................................................... 3

BID DOCUMENT CHECK LIST .................................................................................................................................... 4

SECTION A ................................................................................................................................................................... 7

1. LEGISLATIVE AND REGULATORY FRAMEWORK ............................................................................................... 7

2. BID INFORMATION SESSION ................................................................................................................................. 7

3. EVALUATION CRITERIA .......................................................................................................................................... 7

3.2 PHASE II: MANDATORY REQUIREMENTS .......................................................................................................... 8

3.2.1 LEGISLATIVE REQUIREMENTS TO THIS BID .................................................................................................. 8

3.2.2 RESPONSIVE BIDS ............................................................................................................................................. 9

3.2.3 BID RESPONSE DOCUMENT ............................................................................................................................. 9

3.2.4 AUTHORISATION DECLARATION ..................................................................................................................... 9

3.1.5 TAX COMPLIANCE STATUS ............................................................................................................................ 10

4. PHASE III: PRODUCT TECHNICAL COMPLIANCE .............................................................................................. 11

4.2 COMPLIANCE WITH SPECIFICATIONS .............................................................................................................. 12

5. PHASE IV: PREFERENCE POINT SYSTEM .......................................................................................................... 12

6. PREFERENCE FOR LOCALLY PRODUCED PRODUCTS.................................................................................... 13

SECTION B ................................................................................................................................................................. 19

7. VALUE ADDED TAX ............................................................................................................................................... 14

8. SUBMISSION OF BIDS .......................................................................................................................................... 14

9. COMPLETION OF DOCUMENTS AND BID SUBMISSION.................................................................................... 16

10. LATE BIDS ............................................................................................................................................................ 17

SECTION C ................................................................................................................................................................. 27

11. COUNTER CONDITIONS ..................................................................................................................................... 17

12. FRONTING ........................................................................................................................................................... 17

13. SUPPLIER DUE DILIGENCE ................................................................................................................................ 18

14. COMMUNICATION ............................................................................................................................................... 18

29. CEDING, MERGERS, TAKE OVERS AND CHANGES IN SUPPLIER DETAILS ................................................. 33

15. CONTACT DETAILS ............................................................................................................................................. 18

16. CONTRACT PERIOD ............................................................................................................................................ 19

17. PARTICIPATING AUTORITIES AND OTHER HEALTH ESTABLIHSMENT ........................................................ 19

18. REGISTRATION ON DATABASES OF PARTICIPATING AUTHORITIES ........................................................... 19

19. POST AWARD PARTICIPATION .......................................................................................................................... 20

20. AWARD CONDITIONS ......................................................................................................................................... 20

21 NEGOTIATIONS .................................................................................................................................................... 22

2. NON-COMMITMENT ............................................................................................................................................ 22

23. PRICE REVIEW .................................................................................................................................................... 22

24. QUALITY ............................................................................................................................................................... 26

25. DELIVERY AND QUANTITIES ............................................................................................................................. 26

26. SUPPLIER PERFORMANCE MANAGEMENT ..................................................................................................... 27

27. PACKAGING, LABELLING AND BARCODES ...................................................................................................... 30

28 SHELF LIFE ........................................................................................................................................................... 32

30. THIRD PARTIES ................................................................................................................................................... 33

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ABBREVIATIONS

API : Active Pharmaceutical Ingredient

BAC : Bid Adjudication Committee

B-BBEE : Broad-Based Black Economic Empowerment

CPA : Contract Price Adjustment

CSD : Central Supplier Database

EAN : European Article Numbering

EME : Exempted Micro Enterprise

GMP : Good Manufacturing Practice

MCC : Medicines Control Council

MHPL : Master Health Products List

MPC : Master Procurement Catalogue

NDoH : National Department of Health

PPPFA : Preferential Procurement Policy Framework Act

QSE : Qualifying Small Enterprise

RoE : Rate of Exchange

SAHPRA : South African Health Products Regulatory Authority

SARS : South African Revenue Service

SBD : Standard Bidding Document

VAT : Value- Added Tax

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BID DOCUMENT CHECK LIST

All bid documents listed below must be sorted, filed and submitted in the exact compilation sequence as indicated

below and the annexure attached.

Submission of bid documents is compulsory, unless it's not applicable and indicated as such in the "N/A" column.

All bid documents must be signed.

Bidders not complying to any of the requirements may deemed to be non-responsive and will not be considered for

evaluation

Compilation

Sequence

Admin

Code

Document Name N/A Yes No Remark

1 CL Covering Letter

2 BSRA Bid Signature. Resolution/Authority to sign bid

3 BFI Bid/File Index

4 PBD4.1 PBD 4.1: Contact Details of Bidder

5 SBD5.1 SBD 1: Invitation to bid

6 TCP Tax Clearance Pin Issued

7 CSD CSD Registration report - A certified copy of

latest and complete report. Note: CSD

summary report will not be accepted.

8 SBD4 SBD 4: Declaration of interest

9 PBD9 PBD9: Directors: Categorisation by race,

gender and disability

10 SBD5 SBD5: The National Industrial Participation

Programme

11 SBD6 SBD 6(1): Preference Points Claimed (B-

BBEE)

12 BBBEE Valid B-BBEE certificate (certified copy) or

Sworn Affidavit to claim preference points

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Compilation

Sequence

Admin

Code

Document Name N/A Yes No Remark

13 SBD8 SBD 8: Declaration of Past SCM Practices

14 SBD9 SBD 9: Certificate of Independent Bid

Determination

15 PBD1 PBD1: Authorisation Declaration

Note: Non-compliance to submission of a valid

authorisation declaration, where applicable,

may invalidate the bid.

16 PBD1.1 PBD 1.1: List of products offered sourced from

third party

17 PBD1.2 PBD 1.2: Unconditional written undertaking

from the third party.

18 PBD5 PBD5: Good Manufacturing Practice (GMP).

Declaration of compliance.

19 PBD8 PBD 8: Special Requirements and Conditions

of Contact. Declaration of compliance.

20 CIPC CIPC/CIPRO or proof of

ownership/shareholding. Certified copies of

istration certificates

21 NC Proof of company cedings, mergers and name

changes

22 LICMI Licence to manufacture or import (in the name

of the bidder), including all annexures.

Certified copies required.

23 LICM Licence to manufacture medicines, including

all annexures for local manufacturing sites

as listed on the MRC of the bidder (applicant).

Certified copies required.

24 MRC Medicine Registration Certificates (MRC) with

all the associated conditions of registration -

Certified copies

Note: All MRC's must be marked by the

bidder with the relevant item number and

be sorted and filed in numerical order.

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Compilation

Sequence

Admin

Code

Document Name N/A Yes No Remark

25 PI Original Package Insert (PI) or document

detailing professional information approved by

the Medicines Control Council (MCC) or the

South African Health Products Regulatory

Authority (SAHPRA) for each product offered.

Note: All PI`s must be marked with the relevant

item number and be sorted and filed/submitted

in numerical order.

26 PS Proof of sample submission

27 BL Bidder`s item list (List of products offered)

28 PRICE Signed Excel Bid Response Pricing Schedule

If the Excel Bid response Pricing Schedule is

not signed in the space provided, the bid will

not be considered for evaluation.

All bid documents listed above must be sorted, filed and submitted in the exact order as indicated above

Submission of supporting bid documents is compulsory, unless it's not applicable and indicated as such in the "N/A"

column

The bid document check

list

is available as Annexure A in an excel spreadsheet format and should

be completed by all bidders and be submitted in hard copy and as part of the electronic copies of

Set 3: Electronic version of bid documents".

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SECTION A

1. LEGISLATIVE AND REGULATORY FRAMEWORK

This bid and all contracts emanating there from will be subject to the Medicines and Related Substances Act,

(Act 101 of 1965), Pharmacy Act, (Act 53 of 1974); Patents Act, 1978 (Act 57 of 1978); Trade Marks Act, 1993

(Act 194 of 1993); General Conditions of Contract issued in accordance with Treasury Regulation 16A published

in terms of the Public Finance Management Act, 1999 (Act 1 of 1999). The Special Requirements and

Conditions of Contract (SRCC) are supplementary to General Conditions of Contract (GCC). Where, however,

the SRCC are in conflict with the GCC, the SRCC prevail.

2. BID INFORMATION SESSION

As the National Department of Health complies with the regulations made under the Disaster Management Act,

2002, published in the Gazette 18 March 2020 no briefing session or public bid opening will be held.

3. EVALUATION CRITERIA

The evaluation process will be conducted in phases as follows:

Phase I Phase II Phase III Phase IV

Mandatory and other bid

requirements

Product technical

compliance

Price and

B-BBEE

Recommendation

and Award

Compliance with

mandatory and other bid

requirements

Compliance with technical

specifications

Reports received from

sample evaluation

Bids evaluated in

terms of the 90/10

preference system

Recommendation

and award

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3.1

PHASE I: MANDATORY REQUIREMENTS

Bidders must submit all required documents indicated above with the bid documents at the closing date

and time of the bid. During this evaluation phase, bidder’s responses will be evaluated based on the

documents submitted under mandatory requirements. This phase is not scored and bidders who fail to

comply with all mandatory requirements will be disqualified.

3.1.1 LEGISLATIVE REQUIREMENTS TO THIS BID

Items offered must be registered in terms of section 15 of the Medicines and Related Substances Act,

1965 (Act 101 of 1965), and must comply with the conditions of registration for the duration of the

contract.

A certified copy of the Medicine Registration Certificate, issued in terms of section 15(3)(a) of the

Medicines and Related Substances Act, 1965 (Act 101 of 1965), must be included with the bid for all

items offered.

The bidder must be indicated as the applicant on the Medicines Registration Certificate.

The bidder offering a product must be the holder of a licence to manufacture or import medicines issued

in terms of section 22C (1)(b) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965)

including all annexures. A certified copy of such licence must be submitted by the bidder offering the

product.

The bidder offering a product must submit a certified copy of the licence to manufacture medicines,

including all annexures for local manufacturing sites listed on the MRC of the bidder who must also be the

applicant.

Bidders must comply with the requirements of the Patents Act, 1978 (Act 57 of 1978) and the Trade

Marks Act, 1993 (Act 194 of 1993). Where applicable, an explanation for any non-compliance must be

provided. In the case where a product is manufactured under a voluntary license issued by the patent

holder of such a product, a letter authorising the marketing of the product, provided to the bidder by the

patent holder must be submitted with the bid.

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3.1.2 RESPONSIVE BIDS

Bidders are required to submit responsive bids by completing all the prices in the Excel Bid Response

Document and response fields in the fillible PDF bid document. In this regard, bidder’s attention is drawn

to the document “Definition of fields in the Bid Response Document” explaining the different fields in the

bid document.

3.1.3 BID DOCUMENTS

Bidders are required to submit responsive bids by completing all the prices, mandatory response fields and

item questionnaires.

The excel bid response documents i.e pricing schedule and Directors: Categorisation of race, gender and

disability provided forms an integral part of the bid document and bidders must ensure that it is completed

without changing the structure thereof. All pages must be signed, if not your bid will not be considered for

evaluation.

The prices quoted must be furnished as all inclusive (incl. VAT) on the basis of supply and delivery.

The bid price offered for a product is deemed to be for the pack size as advertised in the item

specification and the unit specified.

Prices submitted must not exceed the ex-manufacturer component of the Single Exit Price inclusive of

VAT.

3.1.4 AUTHORISATION DECLARATION

Only the holder of a Medicines Registration Certificate issued in terms of the Medicines and Related

Substances Act, 1965 (Act 101 of 1965), may submit a bid.

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In the event that the Manufacturer, Packer or other entity, as listed on the certificate of registration are

external third parties, the bidder must ensure that all legal, financial and supply arrangements have been

mutually agreed upon between the bidder and these third parties.

Where a third party is involved in any capacity, the bidder must submit a duly completed and signed

Authorisation Declaration (PBD1) for each such third party.

The National Department of Health reserves the right to verify any information supplied by the bidder in

the Authorisation Declaration and, should the information be found to be false or incorrect, the National

Department of Health will exercise any of the remedies available to it in the bid documents.

Failure to submit a duly completed and signed Authorisation Declaration, with the required annexure(s), in

accordance with the above provisions, will invalidate the bid for such goods or services offered.

No agreement between the bidder and any third party will be binding on the National Department of

Health.

3.1.5 TAX COMPLIANCE STATUS

The Central Supplier Database and the tax compliance status PIN are the approved methods of verifying

the tax compliance status of a bidder. The South African Revenue Service does not issue Tax Clearance

Certificates anymore but has introduced an online provision via eFiling, for bidders to print their own

Tax Clearance Certificates which they can submit with their bids or price quotations.

It is a condition of this bid that the tax matters of the bidder be in order at any point in time, or that

satisfactory arrangements have been made with SARS to meet the bidder’s tax obligations.

It is a requirement that bidders grant a written confirmation when submitting this bid that SARS may, on

an on-going basis during the tenure of the contract, disclose the bidder’s tax compliance status and, by

submitting this bid, such confirmation is deemed to have been granted.

Bidders are required to be registered on the Government's Central Supplier Database and to include in

their bid their Master Registration Number (Supplier Number) in order to enable the institution to verify

the supplier's tax status on the Central Supplier Database;.

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Foreign suppliers with neither South African tax obligations nor history of doing business in South

Africa must complete the questionnaire on the SBD1. Where a recommendation for award of a bid has

been made to a foreign bidder, the NDOH will submit the bidder's completed SBD1 to the South African

Revenue Service to email address: Governmentlnstitute@sars.gov.za. The South African Revenue

Service will issue a confirmation of tax obligations letter to the NDOH, confirming whether or not the

foreign entity has tax obligations in South Africa

Should the recommended bidder fail to provide written proof of their tax compliance status, the NDOH

wull reject the bid submitted by the bidder.

The National Department of Health shall verify the bidder’s tax compliance status through the CSD.

Where consortia/joint ventures/sub-contractors are involved, each party must be registered on the Central

Supplier Database and their tax compliance status will be verified through the Central Supplier Database.

Bidders remain responsible to update their CSD information in line with the bid documents submitted for

this bid.

PHASE II: PRODUCT TECHNICAL COMPLIANCE

4.1 SAMPLES TO BE SUBMITTED TO HEALTH ESTABLISHMENTS

All bidders are required to submit samples, including bidders who are currently supplying the National

Department of Health with products to confirm the following:

 Compliance with specifications as set out in the bid document/item specification.

 Compliance of the product with the requirements of the Medicines and Related Substances Act, 1965 (Act

101 of 1965).

Failure to submit samples at both health establishments listed below will invalidate the bid for such items offered.

Samples are required to be submitted to each (both) of the addresses indicated below prior to closing date and

time of bid:

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Mr Dumisani Malele

Depot Manager

Tel: 011 628 9131

Gauteng: Medical Supplies Depot

Store 3

35 Plunkett Avenue

Hurst Hill

2092

Mr Nisaar Mia

Pharmaceutical Policy Specialist

Tel: 021 483 5800

Western Cape: Department of Health

4th Floor, Cape Medical Depot

16 Chiappini Street

Cape Town

8001

 No samples must be sent to the National Department of Health.

 Samples must be marked with the bid number, the item number as well as the bidder’s name and address.

 Bidders must submit at least one original pack of each offer for evaluation.

 It is the responsibility of the bidder to ensure that samples have been received at the addresses provided

above.

 All samples for awarded items will be retained for the period of the contract.

 All samples must be a true representation of the product which will be supplied.

 All samples submitted must include the package insert or document detailing professional information

approved by the MCC or SAHPRA.

 Proof of sample submission, including a signed copy of the item list as received by the sample evaluation

site, must be submitted with the bid documents at the closing date and time of the bid.

4.2 COMPLIANCE WITH SPECIFICATIONS

Items must comply with the specification as detailed in the bid document.

5. PHASE III: PREFERENCE POINT SYSTEM

5.1 A MAXIMUM OF 80 OR 90 POINTS IS ALLOCATED FOR PRICE ON THE FOLLOWING BASIS

80/20 or 90/10

















min

180

PPt

















min

190

PPt

Where

Ps = Points scored for price of bid under consideration

Pt = Price of bid under consideration

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Pmin = Price of lowest acceptable bid

5.2 POINTS AWARDED FOR B-BBEE STATUS LEVEL OF CONTRIBUTOR

In terms of Regulation 6(2) and 7(2) of the Preferential Procurement Regulations, preference points must be

awarded to a bidder for attaining the B-BBEE status level of contribution in accordance with the table below:

B-BBEE Status Level of

Contributor

Number of points

(90/10 system)

Number of points

(80/20 system)

1 10 20

2 9 18

3 6 14

4 5 12

5 4 8

6 3 6

7 2 4

8 1 2

Non-compliant contributor 0 0

For this tender, the 90/10 preference point system will be applied.

 Bidders are required to complete the preference claim form (SBD 6.1), and submit a valid certified copy of

B-BBEE status level verification certificate, at the closing date and time of the bid in order to claim the B-BBEE

status level point.

 The points scored by a bidder in respect of the level of B-BBEE contribution will be added to the points scored

for price.

 Only bidders who have completed and signed the declaration part of the preference claim form and who have

submitted a B-BBEE status level certificate issued by a registered auditor, accounting officer (as contemplated

in section 60(4) of the Close Corporation Act, 1984 (Act No. 69 of 1984)) or an accredited verification agency

will be considered for preference points.

 If the bidder fails to comply with the paragraphs above, the bidder will be deemed not to have claimed

preference points for B-BBEE status level of contribution and will therefore be allocated a zero (0). The National

Department of Health may, before a bid is adjudicated or at any time, require a bidder to substantiate claims it

has made with regard to preference claimed. The points scored will be rounded off to the nearest two (2)

decimals. In the event that two (2) or more bids have scored equal total points, the contract will be awarded to

the bidder scoring the highest number of preference points for B-BBEE.

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 A contract may, on reasonable and justifiable grounds, be awarded to a bid that did not score the highest

number of points.

6. PREFERENCE FOR LOCALLY PRODUCED PRODUCTS

The National Department of Health reserves the right to consider locally produced products offered. In order to

provide preference to locally produced products, the definition of a locally produced product will be limited to

product formulation and conversion processes that use materials and components to manufacture medicines

(including importation of raw material of active pharmaceutical ingredients (API) and of excipients for production

of finished products) in the Republic of South Africa.

Bidders are required to indicate on the Excel Bid Response Document where the products are manufactured.

Where the National Department of Health gives preference to locally produced products, the quantities for these

items will be allocated and awarded proportionately to locally produced products, provided this does not

negatively impact upon security of supply and affordability.

Bids for products that qualify for this preference must comply with all of the following criteria:

 The South African Health Product Authority (SAHPRA) certificate of registration for a product lists the primary

site of production as one that is located in the Republic of South Africa;

 The bidder offering a product must be the holder of a licence to manufacture or import medicines issued in

terms of section 22C (1)(b) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) including

all annexures. A certified copy of such licence must be submitted by the bidder offering the product.

 The bidder offering a product must submit a certified copy of the licence to manufacture medicines, including

all annexures for local manufacturing sites listed on the MRC of the bidder who must also be the applicant..

 The reference price as published by National Department of Health has not been exceeded (if applicable);

 The site/s of manufacture and/or packaging for the product offered is located in South Africa;

 Demonstrated capacity to service the required volumes as evaluated in terms of the data provided in the Excel

Bid Response Document;

 Previous supplier performance;



Compliance to all other aspects contained in these Special Conditions of Contract

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VALUE ADDED TAX

All bid prices must be inclusive of 15% Value-Added Tax. Failure to comply with this condition will invalidate the

bid.

SUBMISSION OF BIDS

All bid documents listed below must be sorted, filed and submitted in the exact compilation sequence as

indicated below and the annexure attached.

Submission of bid documents is compulsory, unless it's not applicable and indicated as such in the "N/A" column

in the Bid Document Check List.

All bid documents must be signed.

Bidders not complying to any of the requirements may deemed to be non-responsive and will not be considered

for evaluation

 Covering Letter i.e. limited stock availability of any item offered, non-compliance;

 Status relating to TAX, B-BBEE, License to Manufacture, Certificates etc. Bid Signature;

 Resolution/Authority to sign bid;

 Bid/File Index;

 PBD 4.1: Contact Details of Bidder;

 SBD 1: Invitation to bid;

 Tax Clearance Pin Issued;

 CSD Registration report - A certified copy of latest and complete report. Note: CSD summary report will not

be accepted;

 SBD 4: Declaration of interest;

 PBD9: Directors: Categorisation by race, gender and disability;

 SBD5: The National Industrial Participation Programme;

 SBD 6(1): Preference Points Claimed (B-BBEE);

 Valid B-BBEE certificate (certified copy) or Sworn Affidavit to claim preference points;

 SBD 8: Declaration of Past SCM Practices;

 SBD 9: Certificate of Independent Bid Determination;

 PBD1: Authorisation Declaration Note: Non-compliance to submission of a valid authorisation declaration,

where applicable, may invalidate the bid;

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 PBD 1.1: List of products offered sourced from third party;

 PBD 1.2: Unconditional written undertaking from the third party;

 PBD5: Good Manufacturing Practice (GMP). Declaration of compliance;

 PBD 8: Special Requirements and Conditions of Contact. Declaration of compliance;

 CIPC/CIPRO or proof of ownership/shareholding. Certified copies of registration certificates;

 Proof of company cedings, mergers and name changes;

 Certified copy of Licence to manufacture or import (in the name of the bidder), including all annexures;

 Certified copy of Licence to manufacture medicines, including all annexures for local manufacturing sites as

listed on the MRC of the bidder (applicant);

 Certified copies of Medicine Registration Certificates (MRC) with all the associated conditions of registration

(Annexure). Note: All MRC's must be marked by the bidder with the relevant item number and be sorted and

filed in numerical order;

 Original Package Insert (PI) or document detailing professional information approved by the Medicines Control

Council (MCC) or the South African Health Products Regulatory Authority (SAHPRA) for each product offered.

Note: All PI`s must be marked with the relevant item number and be sorted and filed/submitted in numerical

 order;

 Proof of sample submission;

 Bidder`s item list (List of products offered); and

 Signed Excel Bid Response Pricing Schedule (All prices must be submitted in 2 (two) decimals). If the Excel

Bid response Pricing Schedule is not signed in the space provided, the bid will not be considered for evaluation

COMPLETION OF DOCUMENTS AND BID SUBMISSION

Bidders are required to submit three sets of bid documents according to the instructions below. All three sets

must be submitted not later than the closing date and time. Set 2 and Set 3 must be included on a CD with Set 1

and submitted in a sealed package. The full name and address of the bidder, including the return address, the

bid number and the closing date must be clearly indicated on the package. All fields must be completed. Where

information requested is not relevant this should be indicated with N/A.

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Set 1: Hard copy legally binding bid documents

Bidders must complete all SBD, PBD and Bid Response forms in black ink, typed. Where no electronic entry

field is provided bidders must complete the forms in black ink, handwritten in capital letters. The signed hard

copy of the bid document will serve as the legal bid document.

Bidders must submit their complete bid in hard copy format (paper document). The Chief Executive Officer, Chief

Financial Officer, or authorised designee of the entity submitting the bid must sign the official signature pages.

All pages in the complete bid document must be initialed by same with black ink. The use of correction fluid is

not acceptable. Any change/s must be clearly indicated and initialed.

As the National Department of Health complies with the regulations made under the Disaster Management Act,

2002, published in the Gazette 18 March 2020 no briefing session of public bid opening will be held. However,

Bidders must still ensure that that bids are delivered on time to the correct address and deposited in the Tender

Box. Late bid will not be accepted for consideration.

Bidders must refrain from using binding methods like coil, comb, wire velobind, screw binding etc. It is

requested that bidders pre-punch two holes on the left hand side of bid documents suitable for filing in a

two hole lever arch file. Bid documents should be tied in parcels using string or rope that can be easily

untied for filing purposes.

Set 2: PDF of Hard Copy, signed legal documents. (i.e. pdf of Set 1)

Bidders must submit a PDF version of the entire signed hardcopy bid, including all certificates and documents

requested.

Set 3: Electronic version of bid documents

Bidders must submit the electronic versions (editable pdf) of all SBD and PBD documents, Bid Response

Document and other relevant spreadsheets in Excel (not pdf).

All three sets of information must be submitted in order for the bid to be evaluated.

Ensure that the bid price is offered for the product as specified.

Bidders must ensure that the price quoted for a product (line item) on the Bid Response Document is for the

unit pack as specified. No conversion factors will be applied

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10.

LATE BIDS

Bids received after the closing date and time, at the address indicated in the bid documents, will not be accepted

for consideration and, where practical, be returned unopened to the bidder.

11.

COUNTER CONDITIONS

Bidders’ attention is drawn to the fact that amendments to any of the bid conditions or setting of counter

conditions by bidders may result in the invalidation of such bids.

12.

FRONTING

The National Department of Health supports the spirit of broad based black economic empowerment and

recognises that real empowerment can only be achieved through individuals and businesses conducting

themselves in accordance with the Constitution and in an honest, fair, equitable, transparent and legally

compliant manner. Against this background, the National Department of Health condemns any form of fronting.

The National Department of Health, in ensuring that bidders conduct themselves in an honest manner will, as

part of the bid evaluation processes, conduct or initiate the necessary enquiries/investigations to determine the

accuracy of the representation made in bid documents. Should any of the fronting indicators as contained in the

Guidelines on Complex Structures and Transactions and Fronting, issued by the Department of Trade and

Industry, be established during such enquiry/investigation, the onus will be on the bidder/contractor to prove that

fronting does not exist. Failure to do so within a period of 14 days from date of notification, may invalidate the

bid/ contract and may also result in the restriction of the bidder/contractor to conduct business with the public

sector for a period not exceeding 10 years, in addition to any other remedies the National Treasury may have

against the bidder/contractor concerned.

13.

SUPPLIER DUE DILIGENCE

The National Department of Health reserves the right to conduct supplier due diligence prior to final award or at

any time during the contract period. This may include site visits to assess whether an item is manufactured at

the site specified in the bid and the site complies with quality criteria.

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14. COMMUNICATION

The National Department of Health, may communicate with bidders where clarity is sought after the closing date

and time of the bid and prior to the award of the contract, or to extend the validity period of the bid, if necessary.

Any communication to any government official or a person acting in an advisory capacity for the National

Department of Health in respect of this bid between the closing date and the award of the bid by the bidder is

discouraged.

All communication between the bidder and the National Department of Health, must be done in writing.

15. CONTACT DETAILS

Postal address

Directorate: Affordable Medicines

Private Bag X828

PRETORIA

0001

Physical address

Directorate: Affordable Medicines

Civitas Building

242 Struben Street

Cnr Thabo Sehume Street

Pretoria

0002

Please use the following e-mail address for any queries relating to bidding process:

 tenders@health.gov.za

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SECTION B

16.

CONTRACT PERIOD

The contract shall be for the period from 01 January 2021 to 31 December 2022.

17.

PARTICIPATING AUTHORITES AND OTHER HEALTH ESTABLISHMENTS

Participating Authorities and Health Establishments which will be participating authorities in this contract are

National Departments, Provincial Departments and orther institutions as approved by the accounting officer.

Provincial Departments:

 Eastern Cape;

 Free State;

 Gauteng;

 KwaZulu-Natal;

 Limpopo.

 Mpumalanga;

 Northern Cape;

 North West;

 Western Cape; and

Other Institutions:

 Nelson Mandela Childrens' Hospital

18.

REGISTRATION ON DATABASES OF PARTICIPATING AUTHORITIES

All contracted suppliers must register on the supplier databases of Participating Authorities within 30 days

after award of contract.

Failure to meet this requirement will result in inability to process payment for goods.

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19.

POST AWARD PARTICIPATION

Regulation 16A6.6 of the Treasury Regulations for Departments, Trading Entities, Constitutional Entities and

Public Entities, issued in terms of the Public Finance Management Act, 1999, (Act 1 of 1999), states that the

Accounting Officer/Accounting Authority may, on behalf of a department, constitutional institution or public

entity, request to participate in any contract arranged by means of a competitive bidding process by any organ

of state, subject to the written approval of such organ of state and the relevant contractors.

20.

AWARD CONDITIONS

The National Department of Health reserves the right to negotiate prices.

The National Department of Health reserves the right to award the same item as a multiple award to various

contractors (two or more) to address high volume requirements, security of supply and product availability.

The following are examples of considerations which may be taken into account when contemplating a multiple

award:

 Source of Active PharmaceuticaI Ingredient (API) and actual manufacturing site;

 Capacity to meet expected demand as per published estimates in the Excel Bid Response Document;

 Estimated volume to be supplied;

 Risk to public health if the item is not available;

 Past compliance of the bidder with contractual obligations.

In cases where the tender does not achieve the most economically advantageous price, the National

Department of Health reserves the right not to award that item.

In the case of medicines for chronic conditions, pack sizes suitable for a 28-day treatment cycle are required.

Should a 30-day or other pack size be offered, no conversion factor will be applied. Direct comparisons will be

made between the 28-day and other pack sizes during evaluation. Similarly, no conversion factors will be

applied in cases where a pack size other than that specified is offered.

The National Department of Health may change treatment protocols and/or product formulations where

required, due to emerging clinical evidence, disease profiles, safety or resistance patterns and availability of

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items registered in terms of the Medicines and Related Substances Act, 1965, (Act 101 of 1965) at the date

and time of bid closure. In these circumstances, the National Department of Health reserves the right to cancel

the contract for an item, or adjust the quantity awarded based on expected changes in projected demand.

The Department of Health will notify the contracted supplier within a reasonable time of the expected change.

However, in cases where patient safety is a concern, these changes may be implemented with immediate

effect.

20.1 SPLIT AND MULTIPLE AWARDS

The National Department of Health reserves the right to issue split or multiple awards, where necessary, to

ensure security of supply.

The following will be taken into consideration when contemplating a split award:

 Source of API and manufacturing site.

 Capacity to meet expected demand as per published estimates in the Bid Response Document.

 Estimated volume to be supplied.

 Risk to public health if the item is not available.

 Past compliance of the bidder with contractual obligations.

Two-way split awards will be made in accordance with the following schedule based on the points scored:

Category Difference between points

scored

Recommended percentage split

A Equal points 50/50

B < 5 points 60/40

C >5-10 points 70/30

D >10-20 points 80/20

E >20 points 90/10

Where a split for more than 2 suppliers is contemplated, the following formula may be used to allocate

volumes for award:

 For a three way split: Supplier share = 33.3% + (supplier score - mean score) x 2.3%

 For a four way split: Supplier share = 25% + (supplier score - mean score) x 2%

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NEGOTIATIONS

The National Department of Health reserves the right to negotiate with the bidders prior to award and with the

successful bidder(s) post award.

22.

NON-COMMITMENT

The National Department of Health reserves the right not to award, to award in part, or in full.

The right is also reserved to withdraw or amend any of the bid conditions, by notice, in writing to all bidders

prior to closing of the bid and post award.

In the event that an incorrect award has been made, the National Department of Health reserves the right to

remedy the matter in any manner it may deem fit.

23.

PRICE REVIEW

The National Department of Health envisages three types of price review processes for the duration of this

contract:

 A routine adjustment to mitigate foreign exchange fluctuations;

 An exceptional adjustment to mitigate significant short-term foreign exchange fluctuations; and

 A systematic review of prices for comparable products available in the international market place.

23.1 ELIGIBILITY RELATING TO RATE OF EXCHANGE ADJUSTMENTS

Eligibility for price adjustments relating to foreign exchange risk depends on:

The submission of a complete price breakdown per instructions below for all relevant products; and

Assessment of the rationality of this price breakdown by the National Department of Health.

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23.1.1 INSTRUCTIONS FOR PRICE BREAKDOWN

The price breakdown must be completed on the signed bid response document as well as the electronic

version. The delivered price must be divided across five components:

 Active Pharmaceutical Ingredients (API);

 Formulation;

 Packaging;

 Logistics (this includes transportation, warehousing and distribution);

 Gross margin (remaining portion).

 The sum of these categories must be equal to 100% of the delivered price for the line item.

 The local + imported portions of the first three components must add up to 100% within each component

(e.g. Portion of API attributable to local + Portion of API attributable to import = 100% of specific API

component).

 VAT must be apportioned equally across all components and not regarded as a separate component.

 Labour must be apportioned appropriately across the relevant components.

 Breakdown must be in percentage format to the closest whole percentage (e.g. 20%).

 The National Department of Health reserves the right to engage with bidders to verify any of the components

of the bid price, which may include audit of invoices and related documentation.

23.2 PRICE ADJUSTMENTS RELATING TO FOREIGN EXCHANGE RISK

Only the portion of the bid price facing foreign exchange risk will be adjusted. This portion is determined by the

price breakdown on the signed bid submission.

Adjustments are always calculated using the original awarded contracted price as the base.

Price adjustments relating to foreign exchange will be based on the percentage change between the relevant

base average rate of exchange (RoE) and an adjustment average RoE.

Rates are sourced from the Reserve Bank (www.resbank.co.za).

Eligibility for favourable Contractual Price Adjustments may be withdrawn in light of evidence of poor

compliance with contractual obligations.

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Base average RoE for this tender will be as follows, per currency:

Currency

Base Average Rates of Exchange

Average for the period 1 November 2019 to 30

April 2020

Rand per US Dollar 15.63

Rand per Br Pound 19.96

Rand per Euro 17.21

Rand per Yuan Renminbi 2.22

Rand per Indian Rupee 0.21

Should the bidder make use of any currency not mentioned above, the bidder must stipulate this clearly and

submit the calculated average RoE for the period 1 November 2019 to 30 April 2020 using the South African

Reserve Bank published rates for the specific currency.

23.3 APPLICATION FOR CONTRACTUAL PRICE ADJUSTMENTS

Scanned copies of signed applications for price adjustments must be received by the National Department of

Health prior to the submission dates detailed in the tables below.

Where no application for an adjustment relating to foreign exchange has been received and such an

adjustment would be favourable to the Department, this will be implemented automatically.

Foreign exchange adjustments may never result in a price exceeding the current Single Exit Price, ex

Logistics.

23.4 ROUTINE PRICE ADJUSTMENTS

Schedules for routine price reviews, and periods for calculating adjustment average RoE are detailed in the

table below:

Review Period for calculating adjustment

average RoE

Submission of request

for price review to reach

the office by

Date from which adjusted

prices will become

effective

1 01 January 2021 - 30 June 2021 02 July 2021 02 August 2021

2 01 July 2021 - 31 December 2021 03 January 2022 01 February 2022

3 01 January 2022 - 30 June 2022 04 July 2022 01 August 2022

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23.5 EXCEPTIONAL PRICE ADJUSTMENTS

Suppliers may request exceptional price adjustments according to the schedule in the table below. These will

be activated if the absolute change between the base RoE and the three month retrospective average RoE

indicated in the table below fluctuates by more than 10%.

Review

Period for calculating adjustment

average RoE

Submission of request

for price review to reach

the office by

Date from which adjusted

prices will become

effective

0.1 01 January 2021 - 31 March 2021 02 April 2021 03 May 2021

1.1 01 July 2021 - 30 September 2021 04 October 2021 01 November 2021

2.1 01 January 2022 - 31 March 2022 04 April 2022 02 May 2022

3.1 01 July 2022 - 30 September 2022 03 October 2022 01 November 2022

Suppliers who received exceptional adjustments will receive routine adjustments based on the preceding three

months, rather than the usual six month historical average exchange rate. The periods for calculating

adjustment average RoE in these instances are detailed in the table below:

Review Period for calculating adjustment

average RoE post exceptional

adjustment

Submission of request

for price review to reach

the office by

Date from which adjusted

prices will become effective

1 01 April 2021 - 30 June 2021 02 July 2021 02 August 2021

2 01 October 2021 - 31 December 2021 03 January 2022 01 February 2022

3 01 April 2022 - 30 June 2022 04 July 2022 01 August 2022

23.6

PRICE ADJUSTMENTS BASED ON A SYSTEMATIC REVIEW

The National Department of Health reserves the right to review international prices to identify lowest

comparable global prices.

Where this review identifies any prices that are lower than contract prices the National Department of Health

will enter into price negotiations with the contracted supplier.

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Where the outcome of this negotiation is deemed unfavourable, the National Department of Health reserves the

right to terminate the award for the item in question.

24. QUALITY

Products must conform to the conditions of registration of the product in terms of the Medicines and Related

Substances Act, 1965 (Act 101 of 1965) for the full duration of this contract.

25. DELIVERY AND QUANTITIES

25.1 DELIVERY BASIS

Firm lead times for delivery must be quoted for the duration of the contract period.

Transit and storage conditions applicable to the relevant products must be adhered to.

The initial lead time as proposed in the bid response document will be calculated from date of award of the

contract and NOT the date of placement of the first order. This period may not exceed 75 calendar days from

the date of award.

Lead time within the contract period is defined as the time from submission of order to supplier to time of receipt

by the Department, as confirmed by the Proof of Delivery document. This lead time may not exceed 14

calendar days.

Failure to comply with the contractual lead time will result in penalties being enforced as per paragraph 21 and

22 of the General Conditions of Contract.

25.2

QUANTITIES

The quantities reflected in the bid are estimated quantities and no guarantee is given or implied as to the actual

quantity which will be procured during the contract period. Fluctuations in monthly demand may occur.

Proposed minimum order quantities (MOQs) should facilitate delivery directly to health establishments. The

National Department of Health reserves the right to negotiate MOQs where necessary. Where consensus

regarding MOQs cannot be reached, the bid may not be awarded.

Suppliers are required to maintain sufficient buffer stock to meet at least two-months demand for all items,

aligned with the needs of Participating Authorities.

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SECTION C

26.

SUPPLIER PERFORMANCE MANAGEMENT

26.1 Supplier performance management will be the responsibility of Participating Authorities with oversight from

the National Department of Health and, where supplier performance disputes cannot be resolved between the

contractor and the Participating Authority and National Department of Health must be informed for corrective

action.

The National Department of Health, in collaboration with the Participating Authorities, will monitor the

performance of contracted suppliers in terms of this contract, including but not limited to the following:

 Compliance with reporting requirements according to reporting schedule and reporting mechanism.

 As a minimum, suppliers will be required to submit the following information in a specified format and via a

mechanism defined by the National Department of Health:

 All transactional data relating to orders;

 A monthly age analysis;

 Production pipeline data and forecast including:

 Number of units of the item available (stock on hand);

 Number of units of the item in Quality Assurance, awaiting release;

 Number of units of the item in the current month’s production plan.

 Status of outstanding orders.

 Attendance of compulsory quarterly meetings

 The National Department of Health will hold quarterly meetings with suppliers which will include, but not

be limited to, a review of supplier performance and forecasted demand for the next quarter. Suppliers

may be required to present continuous improvement initiatives aimed at improving efficiencies in the

supply chain to benefit both suppliers and the Department of Health.

 The Participating Authorities shall impose penalties, where deemed necessary, as per Paragraph 21 and 22

of the General Conditions of Contract.

 Non-compliance of contracted suppliers to the terms and conditions of this contract may influence

participation in future contracts.

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 Contractors should note that each individual purchasing institution is responsible for generating the order(s)

as well as for the payment(s) thereof.

 Contractors should note that the order(s) will be placed as and when required during the contract period and

delivery points will be specified by the relevant purchasing institution(s).

 The instructions appearing on the official order form regarding the supply, dispatch and submission of

invoices must be strictly adhered to and under no circumstances should the contractor deviate from the

orders issued by the purchasing institutions.

 The Department of Health is under no obligation to accept any quantity which is in excess of the ordered

quantity.

 In order to facilitate efficient implementation of the direct delivery strategy, contracted suppliers must pack

orders for the health establishment as per the purchase order.

 Only orders made using an official, authorised purchase order format are valid.

 Suppliers are required to acknowledge receipt of all purchase orders received from Participating Authorities,

in a manner stipulated by the relevant Participating Authority.

 Changes to any quantities ordered may only be made upon receipt of an amended purchase order.

 The Participating Authorities reserve the right to cancel orders where the lead time exceeds the delivery lead

time specified in the contract and may, at their discretion, purchase supplies of a similar quality and up to

the same quantity in substitution of the goods not supplied in conformity with the contract (as per paragraph

21.6 of the General Conditions of Contract).

 In cases where an order is received which appears to be irrational or misaligned with estimates, the

contracted supplier must liaise with the relevant Participating Authority prior to processing the order.

26.2 DELIVERY ADHERENCE

 Products and related documentation must be delivered in accordance with the terms, conditions and

delivery instructions stipulated on the purchase order.

 The information on invoices and documents relating to delivery must comply with the minimum data

requirements as defined by the National Department of Health.

 Invoices must reflect both the "proprietary name "(brand name"/"trade name") which is unique to a particular

medicine, and which is the name approved in terms of section 15(4) of the Medicines and Related

Substances Act, 1965 (Act 101 of 1965), and the item description as it appears in the contract circular and

Master Procurement Catalogue (MPC), or Master Health Product List (MHPL), which will replace the MPC.

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 Original invoices and proof of delivery must be authorised by a delegated official at the designated delivery

point. These documents must be delivered to the authority responsible for payment. This may or may not

be the same as the delivery address stipulated on the purchase order. Suppliers are required to know where

documents must be delivered.

 The supplier must ensure that products are delivered in accordance with the appropriate conditions of

storage, as per product's conditions of registration. Delivery is deemed to terminate upon signature of

receipt by the delegated official.

 Discrepancies between invoice and physical stock, or damaged stock, will be reported to the contracted

supplier within a reasonable time or as arranged with the supplier. This time period must make provision

for the quantities received to be checked upon receipt of delivery.

 Contracted suppliers will be responsible for collection of goods delivered erroneously, or in the incorrect

condition as formally arranged in consultation with the purchasing authority. The Participating Authorities

may recoup any expenses associated with failure to collect such goods in accordance with the agreement

26.3 CONTINUITY OF SUPPLY

 Contracted suppliers must have at least two months' supply of the estimate at the start of the contract.

 Contractors must maintain sufficient buffer stock throughout the duration of the contract.

 Contractors must inform National Department of Health at first knowledge of any circumstances that may

result in interrupted supply, including but not limited to:

 regulatory action which may impact on their GMP status or that of entities on which they are reliant;

 any anticipated problems associated with the availability of active pharmaceutical ingredient (API);

 industrial action

 challenges with manufacturing pipeline;

 any other supply challenges.

 Contractors must direct official communication relating to continuity of supply to stockalert@health.gov.za,

as well as Participating Authorities.

 Contractors must direct official communication relating to payment challenges to medacc@health.gov.za,

as well as Participating Authorities.

 All official communication must include detail of corrective actions taken by the contracted supplier to ensure

continuity of supply.

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 It is the responsibility of the contracted supplier to ensure continuous availability and supply of contracted

items. In the event that the contracted supplier is unable to supply, the contracted supplier will source

alternative product of acceptable quality and up to the same quantity as required in terms of the contract.

The substitute item will be supplied at the current price of the contracted item.

 Suppliers may be required to pay penalties for supply exceeding the contractual lead time as stipulated in

the General Conditions of Contract Paragraph 22.

 In terms of the General Conditions of Contract and Special Requirements and Conditions of Contract, the

Participating Authorities may purchase outside the contract in order to meet its requirements if the item is

urgently required and is not immediately available.

26.4 REPORTING

National Department of Health will provide the requirements for reporting and successful bidders will be

assisted with complying with these requirements.

The National Department of Health may, from time to time and within reason, add to the reporting requirements.

Any changes to reporting requirements or the reporting mechanism will be communicated in writing by the

Directorate: Affordable Medicines.

27.

PACKAGING, LABELLING AND BARCODES

27.1 PACKAGING

 Suppliers must ensure that products delivered are received in good order at the point of delivery.

Packaging must be suitable for further dispatch, storage and stacking according to Good Wholesaling

Practice and Good Distribution Practice.

 Packaging must be suitable for transportation and should prevent exposure to conditions that could

adversely affect the stability and integrity of the product.

 The packaging must be uniform for the duration of the contract period. All products must be packaged in

acceptable containers, specifically developed for the product.

 The number of units per shipper pack or original carton must be completed in the Bid Response Document.

 Where a particular stacking and storage configuration is recommended by the supplier, this should be

clearly illustrated on the outer packaging.

 Where the contents of the shipper pack represent a standard supply quantity of an item, the following must

be adhered to:

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 Outer packaging flanges must be sealed with suitable tape that will clearly display evidence of

tampering;.

 The contents must be packed in neat, uniform rows and columns that will facilitate easy counting when

opened.

 Where the contents of a shipper pack represent a non-standard supply quantity, the following must

be adhered to:

 Outer packaging flanges must be sealed with suitable tape that will clearly display evidence of

tampering;.

 The shipper pack must contain only one product, mixing of multiple products in a single shipper is not

allowed;.

 The outer packaging must be clearly marked as a "Part Box".

27.2 LABELLING

 All containers, packaging and cartons must be clearly labelled. Bulk packs must be labelled in letters

not less than font size 48.

 The following information must be clearly and indelibly printed on all shipper packs, including any part

boxes:

 Item name as contained in the contract circular and the Master Procurement Catalogue (MPC),

or Master Health Products List (MHPL), which will replace the MPC.

 Registered product name (if applicable);

 Number of units in pack;

 Batch number;

 Expiry date;

 Storage conditions;

 Barcode.

 Where the contents of the shipper pack require special attention in terms of storage and/or handling,

e.g. thermolabile, high-scheduled or cytotoxic products, such instructions must be clearly and visibly

indicated on the outer packaging on a brightly coloured background.

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 Unit packs must be labelled in accordance with Regulation 10 of the General Regulations published

in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). The label must

include a barcode suitable for the identification and tracking of medication.

27.3 BARCODES

 All unit and shipper packs must be marked with the appropriate barcode number and symbology.

 The European Article Numbering Code 13 (EAN 13) has been accepted as standard.

 Suppliers are encouraged to include a 2D barcode or similar on their packaging that will include the

following information:

 Item name as contained in the contract circular and the Master Procurement Catalogue (MPC),

or Master Health Products List (MHPL) which will replace the MPC.

 The "proprietary name (brand name"/"trade name”) unique to a particular medicine, as

approved by MCC or SAHPRA;

 Dosage form and strength;

 Pack size;

 Batch number;

 Expiry date.

SHELF LIFE

 Unless MCC or SAHPRA, has approved a shorter shelf life, products must have a shelf-life of at least 12

months upon delivery.

 Contracted suppliers may apply in writing to Participating Authorities to supply a product with a shorter shelf

life provided that:

 Applications are accompanied by an undertaking that such short-dated products will be unconditionally

replaced or credited before or after expiry; and

 Applications are approved by the Participating Authorities before execution of orders; and

 Upon notification of remaining expired stock such products will be collected by the supplier at their own

cost; and

 Failure to collect the products within 30 days after written notification to the supplier will result in the

disposal of the product by the Participating Authority for the account of the supplier.

 If short-dated products are delivered without the aforementioned undertaking the following discount formula

will be applied for invoicing of short-dated products:

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 A = (12 – months to date of expiry) x 2% x consignment value short dated product. Therefore, amount to be

invoiced is: Consignment value minus A, where A is the value of the outcome of the discount formula.

 Unless otherwise agreed to, any Participating Authority may, without prejudice, decline to accept product

with a shelf-life of less than 12 months.

CEDING, MERGERS, TAKE OVERS AND CHANGES IN SUPPLIER DETAILS

Where a contracted supplier plans to merge with, or is going to be acquired by, another entity or plans to cede

a contract the contracted supplier must inform the National Department of Health in writing at first knowledge of

such an event.

Where a contracted supplier plans to cede a contrated item to another supplier, the contracted supplier must

submit an official request in writing to the NDOH, three months prior to the proposed effective date.

The NDOH reserves the right to accept or decline the request to cede the contractual obligations to the new

supplier under the prevailing conditions of contract or to cancel the contract.

The contracted supplier is obliged to supply the contracted item under the prevailaing conditions of contract,

until such time that the NDOH has approved the request to cede the item to another supplier.

A contracted supplier must inform the National Department of Health at first knowledge of any changes to

address, name, or contact details and effect these changes on the Central Supplier Database.

THIRD PARTIES

Participating Authorities will not make a payment to or consult with a third party.

No third party is entitled to put an account of a Participating Authority on hold.

END

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HP10-2021BIO ITEM LIST

Item No Description Unit Estimate

1 ALBUMIN HUMAN, NORMAL SERUM 20% (10G), 50ML Each 37,528

2 ALBUMIN HUMAN, NORMAL SERUM 20% (20G), 100ML Each 50,590

3 BOTULINUM TOXIN TYPE A LYOPHILISED, 100 IU (0.025MCG) / VIAL Each 6,160

4 HUMAN COAGULATION CONCENTRATE COMPLEX: FACTOR VIII COMPLEX 300 IU INJECTION,

UNIT CONTAINING - A HIGH SPECIFIC FACTOR VIII (FACTOR VIII: C) ACTIVITY - VON

WILLEBRAND FACTOR (FACTOR VIII: VWF) ACTIVITY - VON WILLEBRAND FACTOR ACTIVITY:

FACTOR VIII ACTIVITY = 1:1 KIT FOR RECONSTITUTION AND INJECTION

Each 3,480

5 HUMAN COAGULATION CONCENTRATE COMPLEX: FACTOR VIII COMPLEX 500 IU INJECTION,

UNIT CONTAINING - A HIGH SPECIFIC FACTOR VIII (FACTOR VIII: C) ACTIVITY - VON

WILLEBRAND FACTOR (FACTOR VIII: VWF) ACTIVITY - VON WILLEBRAND FACTOR ACTIVITY:

FACTOR VIII ACTIVITY = 1:1 KIT FOR RECONSTITUTION AND INJECTION

Each 71,160

6 HUMAN COAGULATION CONCENTRATE COMPLEX: FACTOR VIII COMPLEX 1 000 IU

INJECTION, UNIT CONTAINING - A HIGH SPECIFIC FACTOR VIII (FACTOR VIII: C) ACTIVITY -

VON WILLEBRAND FACTOR (FACTOR VIII: VWF) ACTIVITY - VON WILLEBRAND FACTOR

ACTIVITY: FACTOR VIII ACTIVITY = 1:1 KIT FOR RECONSTITUTION AND INJECTION

Each 40,748

7 HUMAN COAGULATION FACTOR CONCENTRATE: ACTIVATED PROTHROMBIN COMPLEX

CONCENTRATE INJECTION, 500 IU, CONTAINING - STANDARD FACTOR VIII INHIBITOR

BYPASSING ACTIVITY, - 0,7 - 2,5 U/MG PROTEIN - FACTOR II, IX AND X MAINLY IN NON-

ACTIVATED FORM AND - FACTOR VII IN ACTIVATED FORM KIT FOR RECONSTITUTION AND

INJECTION

Each 2,400

8 HUMAN COAGULATION FACTOR CONCENTRATE: ACTIVATED PROTHROMBIN COMPLEX

CONCENTRATE INJECTION, 1000 IU, CONTAINING - STANDARD FACTOR VIII INHIBITOR

BYPASSING ACTIVITY, - 0,7 - 2,5 U/MG PROTEIN - FACTOR II, IX AND X MAINLY IN NON-

ACTIVATED FORM AND - FACTOR VII IN ACTIVATED FORM KIT FOR RECONSTITUTION AND

INJECTION

Each 5,790

9 HUMAN COAGULATION FACTOR CONCENTRATE: FACTOR IX COMPLEX, 500 IU INJECTION,

UNIT CONTAINING: - CONCENTRATE OF COAGULATION FACTORS II (PROTHROMBIN), VII

(PROCONVERTIN), IX (CHRISTMAS FACTOR) AND X (STUART-PROWER FACTOR)

Each 24,740

10 HUMAN COAGULATION FACTOR CONCENTRATE: FACTOR VIIA 1MG/VIAL (50 KIU) INJECTION,

UNIT CONTAINING ACTIVATED RECOMBINANT COAGULATION FACTOR VIIA INJECTION

Each 3,055

11 HUMAN COAGULATION FACTOR CONCENTRATE: FACTOR VIIA 2MG/VIAL (100 KIU)

INJECTION, UNIT CONTAINING ACTIVATED RECOMBINANT COAGULATION FACTOR VIIA

INJECTION

Each 2,205

12 HUMAN COAGULATION FACTOR CONCENTRATE: FACTOR VIIA 5MG/VIAL (250 KIU)

INJECTION, UNIT CONTAINING ACTIVATED RECOMBINANT COAGULATION FACTOR VIIA

INJECTION

Each 315

13 IMMUNOGLOBULIN, HUMAN NORMAL INJECTION; FOR INTRAMUSCULAR USE; 5ML SINGLE

DOSE CONTAINING 16% W/V SOLUTION OF GAMMAGLOBULIN

Each 1,853

14 IMMUNOGLOBULIN, HUMAN, ANTI-D (RHESUS) 500 IU(100MCG) /2ML; INJECTION FOR

INTRAMUSCULAR USE, 2ML

Each 44,328

15 IMMUNOGLOBULIN, HUMAN, ANTI- RABIES, 150 IU/ML INJECTION FOR INTRAMUSCULAR USE,

2ML

Each 29,353

Page 1 of 3

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 82

HP10-2021BIO ITEM LIST

Item No Description Unit Estimate

16 IMMUNOGLOBULIN, HUMAN, HEPATITIS B

100 IU/ML; INJECTION FOR INTRAMUSCULAR USE, 2ML

Each 1,765

17 IMMUNOGLOBULIN, HUMAN, NORMAL 12G INJECTION, FOR INTRAVENOUS USE, UNIT

UNIT TO INCLUDE TRANSFER/DEVICE SET, ADMINISTRATION/INFUSION SET, MICRO-

INFUSION SET

Each 17,417

18 IMMUNOGLOBULIN, HUMAN, NORMAL 1G INJECTION, FOR INTRAVENOUS USE, UNIT

UNIT TO INCLUDE TRANSFER/DEVICE SET, ADMINISTRATION/INFUSION SET, MICRO-

INFUSION SET

Each 8,636

19 IMMUNOGLOBULIN, HUMAN, NORMAL 3G INJECTION, FOR INTRAVENOUS USE, UNIT

UNIT TO INCLUDE TRANSFER/DEVICE SET, ADMINISTRATION/INFUSION SET, MICRO-

INFUSION SET

Each 11,201

20 IMMUNOGLOBULIN, HUMAN, NORMAL 6G INJECTION, FOR INTRAVENOUS USE, UNIT

UNIT TO INCLUDE TRANSFER/DEVICE SET, ADMINISTRATION/INFUSION SET, MICRO-

INFUSION SET

Each 11,020

21 IMMUNOGLOBULIN, HUMAN, NORMAL, INJECTION, FOR INTRAMUSCULAR USE, 2ML SINGLE

DOSE CONTAINING 16% W/V SOLUTION OF GAMMAGLOBULIN

Each 240

22 IMMUNOGLOBULIN, HUMAN, TETANUS

125 IU/ML; INJECTION OF INTRAMUSCULAR USE, 2ML

Each 3,023

23 IMMUNOGLOBULIN, HUMAN, VARICELLA ZOSTER, INJECTION FOR IM USE 100 IU/ML, 2ML Each 1,444

24 LYOPHILISED PLASMA, 200 ML Each 74,919

25 LYOPHILISED PLASMA, 50 ML Each 6,940

26 RECOMBINANT ANTIHAEMOPHILIC FACTOR VIII, 1000 IU INJECTION, 1 DOSE VIAL PLUS

DILUENT

Each 3,120

27 RECOMBINANT ANTIHAEMOPHILIC FACTOR VIII, 250 IU INJECTION, 1 DOSE VIAL PLUS

DILUENT

Each 275

28 RECOMBINANT ANTIHAEMOPHILIC FACTOR VIII, 500 IU INJECTION, 1 DOSE VIAL PLUS

DILUENT

Each 8,258

29 TUBERCULIN PPD, LIQUID, TEST, 2TU/0,1ML; UNIT FOR INTRADERMAL TESTING BY

MANTOUX METHOD 1,5ML VIAL KIT TO INCLUDE TRANSPARENT RULE FOR MEASURING

INDURATIONS

Each 136,976

30 VACCINE: HEPATITIS B INJECTION, 20MCG/ML PER DOSE, FOR ADULT USE. FOR

INTRAMUSCULAR ADMINISTRATION

Each 226,640

31 VACCINE: INFLUENZA (INACTIVATED) INJECTION; 0,5ML PREFILLED SYRINGE ANTIGENICITY

ACCORDING TO CURRENT SAHPRA REQUIREMENTS

Each 3,000,000

32 VACCINE: MENINGOCOCCAL MENINGITIS (POLYSACCHARIDE), GROUP A, C, W135 AND Y, 1

DOSE VIAL PLUS DILUENT CONTAINING 50MCG EACH OF POLYSACHARIDE ANTIGEN

GROUPS A, C, W135 AND Y PER DOSE FOR SUBCUTANEOUS ADMINISTRATION

Each 44,808

Page 2 of 3

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 83

HP10-2021BIO ITEM LIST

Item No Description Unit Estimate

33 VACCINE: PNEUMOCOCCAL, 23-VALENT (POLYSACCHARIDE) 0.5ML INJECTION, 1 DOSE VIAL

FOR SUBCUTANEOUS/INTRAMUSCULAR ADMINISTRATION

Each 8,838

34 VACCINE: RABIES INJECTION, 1 DOSE VIAL PLUS SOLVENT INACTIVATED VIRUS WITH A

MINIMUM POTENCY OF 2,5 IU PER DOSE FOR ACTIVE IMMUNISATION

Each 957,055

35 VACCINE: VARICELLA-ZOSTER INJECTION, NOT LESS THAN 19 400 PLAQUE-FORMING UNITS

(PFU)/0.65ML WITH DILUENT, SINGLE DOSE

Each 257

36 VACCINE: YELLOW FEVER INJECTION, 1000 UNITS STRAIN 17 D-204 PER DOSE FOR ACTIVE

IMMUNISATION, SUBCUTANEOUS 0,5ML VIAL PLUS DILUENT

Each 13,630

Page 3 of 3

2020/05/08

Bidder Signature:____________________________

HP10-2021BIO Page 84

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