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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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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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.
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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.
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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.
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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
CO
NTRA
CT
NU
M
B
ER
:
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
4.
National
key
Account
Manager (or Tender Manager)
Name
e-mail
Telephone
Cell
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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
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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: ____________________________
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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
No
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
No
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
No
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
No
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.
1
of 1999);
(b)
any municipality or municipal
entity;
(c)
provincial
legislature;
(d)
national Assembly or the national Council
of
provinces;
or
(e) Parliament.
²”Shareholder” means
a
person who owns shares in the company and
is
actively involved in the management of the enterprise
or
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
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List of the products offered sourced from third party
Bid Item
No
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
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List of the products offered sourced from third
party -
continued
Bid Item
No
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
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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
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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
t
ered legal
name of bidder
The full, regis
t
ered, legal name of
t
he bidder, as on VAT regis
t
ration certifica
t
eand
Medicine Re
g
is
t
ration Certifica
t
ea
p
p
lican
t
.
Quantity for full period
The volume of the item (expressed in units) which the bidder can provide
durin
g
the com
p
lete
p
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
y
. Must be the
p
rice fo
r
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
t
ail devia
t
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
t
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
t
he bid
item, in number of
p
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)
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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
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1
THE NATIONAL TREASURY
Republic of South Africa
_____________________________________________________________________
GOVERNMENT PROCUREMENT:
GENERAL CONDITIONS OF CONTRACT
July 2010
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2
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.
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3
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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4
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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5
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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6
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
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;
(c) furnishing of a detailed operations and maintenance manual
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
(c) if the supplier, in the judgment of the purchaser, has
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
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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Page 3 of 34
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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Special Requirements and Conditions of Contract: HP10-2021BIO
Page 4 of 34
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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Page 5 of 34
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
re
g
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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Page 6 of 34
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.
4.
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
min
180
P
PPt
Ps
or
min
min
190
P
PPt
Ps
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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7.
VALUE ADDED TAX
All bid prices must be inclusive of 15% Value-Added Tax. Failure to comply with this condition will invalidate the
bid.
8.
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
9.
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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21
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.
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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.
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.
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.
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.
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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