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CONTRACT NUMBER HP08-2012SSP/02 SUPPLY AND DELIVERY OF SEMI-SOLID DOSAGE FORMS AND POWDERS TO THE DEPARTMENT OF HEALTH FOR THE PERIOD UP TO 30 JUNE 2014 1. IMPORTANT GENERAL INFORMATION: 1.1 Please note that the delivered price is for the unit of measure (UOM) offered. 1.2 All prices are inclusive of 14 % VAT. 1.3 All prices are on a delivered basis. 1.4 Should an order be placed by any institution other than the provincial medical
depots, the validity of the order must first be confirmed with the relevant depot manager.
1.5 Note that both suppliers and provincial depots will be required to report monthly
to the National Department of Health on the status of all orders placed in terms of this contract.
2. NAMES AND ADDRESSES OF CONTRACTORS AND CONTACT DETAIL
BIDDER LEGAL NAME
POSTAL ADDRESS COMBINED
CONTACT DETAILS ---------------- TELEPHONE FAX NUMBER
CONTACT PERSON ---------------------------- E-MAIL ADDRESS
SUPPLIER CODE
Bliss Pharmaceuticals (Pty) Ltd
P O Box 604 RIDGEWAY 2099
011 496 2355 086 647 5635
Kingsley Tloubatla [email protected] [email protected]
V2GJ5
BMNS Infection Control and Medical Supply Pty Ltd
P O Box 20156 SPRUITVIEW 1425
011 039 2512/011 051 7563 086 623 7589
Motshidisi Bodiba [email protected] V39E0
Mirren Pty Ltd PO Box 87607 HOUGHTON 2041
011 425 4026 011 425 4009
Nosipho Mthembu [email protected]
V7149
Specpharm Holdings Pty Ltd
P O Box 651 HALFWAY HOUSE 1685
011 652 0405/0428 086 211 3266
Jaidev Maharaj/T Shabalala [email protected]/[email protected]
VCEH8
HP08-2012SSP/02: SUPPLY AND DELIVERY OF SEMI-SOLID DOSAGE FORMS AND POWDERS TO THE DEPARTMENT OF HEALTH FOR THE PERIOD UP 30 JUNE 2014 CONTRACT CIRCULAR
Period Up to 30 June 2014 1
Item No Description Quantity Awarded
Supplier Supplier Code Unit price Brand name Unit Pack Shipper Pack
Lead Time (Days)
MOQ Total score
NSN
42 DEXTROSE MONOHYDRATE B.P. crystals orcrystalline powder, 50g containerFor glucose tolerance test. Packed in a well- closed container
32,600 Bliss Pharmaceuticals (Pty) Ltd
V2GJ5 R 3.21 Dextrose 50 g Each 50 units 30 100 98.00 18-974-0713(CO)
43 DEXTROSE MONOHYDRATE B.P. crystals orcrystalline powder, 75g containerFor glucose tolerance test. Packed in a well- closed container
75,800 Bliss Pharmaceuticals (Pty) Ltd
V2GJ5 R 4.15 Dextrose 75 g Each 50 units 30 100 98.00 18-971-6005(CO)
105 ORAL REHYDRATION: Sachet containing: Sodium Chloride 2g, Potassium Chloride1,5g, Sodium Bicarbonate 2.5g, Glucose20g to be dissolved in 1 L water.Solution to provide the following electrolyte concentration:Na+ 64 mmol/LCl- 54 mmol/L K+ 20 mmol/L HCO3- 30 mmol/L Glucose 2%1 sachet
373,300 Specpharm Holdings Pty Ltd
VCEH8 5.13 per sachet
102.60 per box of 20
sachets
Hydrol Solution
Box of 20 sachets
100 sachets [5 x 20 sachets]
42 200 sachets [10 x 20 sachets]
98.00
18-976-2828(BX)
Item No Description Quantity Awarded
Supplier Supplier Code Unit price Brand name Unit Pack Shipper Pack
Lead Time (Days)
MOQ Total score
NSN
105.1 ORAL REHYDRATION: Sachet containing: Sodium Chloride 0.4g, Potassium Chloride0.3g, Sodium Bicarbonate 0.5g, Glucose4g to be dissolved in 200ml water.Solution to provide the following electrolyte concentration:Na+ 64 mmol/LCl- 54 mmol/L K+ 20 mmol/L HCO3- 30 mmol/L Glucose 2%1 sachet
50,000 Mirren Pty Ltd V7149 3.31 per sachet
16.55 per 5 sachets
Electropak Sachets
5 x 5, 48g
30 x 5 x 5, 48g
7 300 sachets
90.00
18-975-3027(PK)
122 SALICYLIC ACID B.P. crystals or crystallinepowder, 500g containerPacked in a well-closed container
3,700 BMNS Infection Control and Medical Supply Pty Ltd
V39E0 R 67.80 Salicylic Acid BP. 500 g
Unit Pack 15 10 98.00 18-971-5499(CO)
Special Conditions of Contract – HP08SSP/02
Special Requirements and Conditions of Contract
HP08-2012SSP/02
SUPPLY AND DELIVERY OF SEMI-SOLID DOSAGE FORMS AND POWDERS TO THE DEPARTMENT OF HEALTH
FOR THE PERIOD UP TO 30 JUNE 2014
VALIDITY PERIOD 120 DAYS
VALIDITY PERIOD 120 DAYS National Department of Health
Special Conditions of Contract – HP08SSP/02
CONTENTS
1. SPECIAL CONDITIONS OF CONTRACT................................................................................ 4
2. EVALUATION CRITERIA ........................................................................................................ 4
3. PRE AWARD SUPPLIER DUE DILIGENCE............................................................................ 6
4. PARTICIPATING AUTHORITIES ............................................................................................ 6
5. CONTRACT PERIOD .............................................................................................................. 6
6. RESPONSE FIELDS ............................................................................................................... 6
7. VALUE ADDED TAX ............................................................................................................... 6
8. TAX CLEARANCE CERTIFICATE .......................................................................................... 7
9. AUTHORISATION DECLARATION AND LEGISLATIVE REQUIREMENTS .......................... 7
9.1 DECLARATION OF AUTHORISATION .................................................................................. 7
9.2 LEGISLATIVE REQUIREMENTS ........................................................................................... 8
9.3 NON COMPLIANCE ............................................................................................................... 9
10. CONTRACT ADMINISTRATION ............................................................................................. 9
11. COUNTER CONDITIONS ...................................................................................................... 10
12. FRONTING ............................................................................................................................ 10
13. PRODUCT COMPLIANCE .................................................................................................... 10
13.1 PRE AWARD PRODUCT COMPLIANCE PROCEDURES ................................................... 10
13.2 SAMPLES............................................................................................................................. 11
14. PRICE QUALIFICATION AND CONTRACT PRICE ADJUSTMENT PROCEDURE.............. 12
14.1 PRICING STRUCTURE ........................................................................................................ 12
14.2 PRICE ADJUSTMENTS ....................................................................................................... 12
14.3 PRICE ADJUSTMENT PERIODS ......................................................................................... 15
14.4 RATES OF EXCHANGE (ROE) – BASE AND AVERAGE RATES ....................................... 16
14.5 GENERAL ............................................................................................................................ 17
15. QUANTITIES, ORDERS AND DELIVERY ............................................................................. 17
15.1 DELIVERY ADHERENCE..................................................................................................... 18
15.2 QUANTITIES AND ORDERS................................................................................................ 18
15.3 MANUFACTURING INFORMATION..................................................................................... 20
16. PACKAGING ......................................................................................................................... 20
17. LABELS AND PACKAGE INSERTS ..................................................................................... 20
18. CONTAINERS ....................................................................................................................... 21
Special Conditions of Contract – HP08SSP/02
19. STERILITY............................................................................................................................. 21
20. BARCODES .......................................................................................................................... 21
21. INSPECTION AND ASSAY ................................................................................................... 21
22. QUALITY ............................................................................................................................... 22
23. SHELF-LIFE .......................................................................................................................... 22
24. POST AWARD ...................................................................................................................... 22
24.1 MERGERS AND TAKE OVER
24.2 MONITORING
25. REPORTING AND HISTORICAL DATA................................................................................ 23
25.1 HISTORICAL DATA.............................................................................................................. 23
25.2 PERFORMANCE MEASURES ............................................................................................. 24
25.2.1 SUPPLIERS MEASURES..................................................................................................... 24
25.2.2 END USER MEASURES ...................................................................................................... 24
26. CONTACT DETAILS ............................................................................................................. 24
1. SPECIAL CONDITIONS OF CONTRACT
This bid and all contracts emanating therefrom will be subject to the 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 Conditions of Contract are supplementary to that of the
General Conditions of Contract. Where, however, the Special Conditions of
Contract are in conflict with the General Conditions of Contract, the Special
Conditions of Contract will prevail.
2. EVALUATION CRITERIA
Preference Points System
a. In terms of regulation 6 of the Preferential Procurement Regulations pertaining
to the Preferential Procurement Policy Framework Act, 2000 (Act 5 of 2000),
responsive bids will be adjudicated by the Department of Health on the 90/10-
preference point system in terms of which points are awarded to bidders on
the basis of:
- The bid price (maximum 90 points)
- B-BBEE status level of contributor (maximum 10 points)
b. The following formula will be used to calculate the points for price:
Ps = 90 1 � Pt � P min
P min
Where
Ps = Points scored for comparative price of bid under consideration
Pt = Comparative price of bid under consideration
Pmin = Comparative price of lowest acceptable bid
A maximum of 10 points may be allocated to a bidder for attaining their
Special Conditions of Contract – HP08SSP/02
B-BBEE status level of contributor in accordance with the table below:
B-BBEE Status Level of Contributor Number of Points 1 10 2 9 3 8 4 5 5 4 6 3 7 2 8 1
Non-compliant contributor 0
c. Bidders are required to complete the preference claim form (SBD 6.1) in
order to claim the B-BBEE status level points.
d. The points scored by a bidder in respect of the level of B-BBEE contribution
will be added to the points scored for price.
e. Only bidders who have completed and signed the declaration part of the
tender documentation may be considered.
f. The 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.
g. The points scored will be rounded off to the nearest 2 decimals.
h. In the event that two 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.
i. A contract may, on reasonable and justifiable grounds, be awarded to a bid
that did not score the highest number of points.
j. The Department of Health reserves the right to negotiate prices
k. The Department of Health reserves the right not to award a line item.
Special Conditions of Contract – HP08SSP/02
3. PRE AWARD SUPPLIER DUE DILIGENCE
The Department of Health reserves the right to conduct supplier due
diligence prior to final award. This may include site visits.
4. PARTICIPATING AUTHORITIES
The National Department of Health and the following Provincial Departments
will participate in this contract:
Provincial Departments of Health: Eastern Cape, Free State, Gauteng,
KwaZulu-Natal, Limpopo, Mpumalanga, Northern Cape, North West and
Western Cape
5. CONTRACT PERIOD
The contract period shall be for a period of 24 months up to 30 June 2014.
6. RESPONSE FIELDS
It is imperative that bidders submit responsive bids by completing all the
mandatory response fields for the individual items. In this regard bidder’s
attention is drawn to the response field and price structure explanations and
examples supplied in the bid document.
Non-compliance with this condition may invalidate the bid for the item/s
concerned.
7. VALUE ADDED TAX
All bid prices must be inclusive of 14% Value-Added Tax.
Failure to comply with this condition may invalidate the bid
Special Conditions of Contract – HP08SSP/02
8. TAX CLEARANCE CERTIFICATE
An original and valid Tax Clearance Certificate issued by the South African
Revenue Services certifying that the tax affairs of the bidder are in order must
be submitted at the closing date and time of bid. Copies or certified copies of the
Tax Clearance Certificate will not be acceptable.
Failure to comply with this condition will invalidate the bid.
9. AUTHORISATION DECLARATION AND LEGISLATIVE REQUIREMENTS
9.1 DECLARATION OF AUTHORISATION
a. In the event of the bidder not being the actual manufacturer and will be
sourcing the product(s) from another company (third party), a signed letter from
the source company to the bidder committing to firm supply arrangement(s) for
each item, including lead times in this regard, must accompany your bid at
closing date and time. The Bid Authorization Form (Form AD1) must be
completed and signed giving full details of the declaration of authorisation and
be submitted with bid documents at the closing date and time of the bid.
b. The said company/manufacturer/supplier issuing such a letter must confirm
that it has familiarised itself with the item description/specification, lead times
and bid conditions and if the bid consists of more than one item, it should be
clearly indicated in respect of which item(s) the supportive letter has been
issued.
c. The Department 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 Department of Health will exercise any of the
remedies available to it in the bid documents.
d. The bidder must ensure that all financial and supply arrangements for goods,
including lead times, have been mutually agreed upon between the bidder and
the third party. No agreement between the bidder and the third party will be
binding on the Department of Health.
Special Conditions of Contract – HP08SSP/02
e. It must be indicated in the letter that all the terms and conditions are mutually
agreed upon
f. Failure to submit a duly completed and signed Authorisation Declaration, with
the required annexure(s), in accordance with the above provisions may
invalidate the bid for such goods offered.
9.2 LEGISLATIVE REQUIREMENTS
a. 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) as amended.
Bidders must submit a copy of the actual patent or an agreement with the patent holder with the bid document at the closing date and time of the bid.
b. Bidders must comply with any legal requirements with regard to voluntary licenses obtained, and proof of agreements in this regard must be supplied with the bid document at the closing date and time of the bid.
c. The bidder offering medicines in terms of this bid must be licensed with the Medicines Control Council (MCC) in terms of section 22C (1) (b) of the Medicines and Related Substances Act, Act 101 of 1965, as amended, and must be the holder of the license according to section 22C (6) of the said Act. A certified copy of the licence including all annexure thereto must be submitted with the bid document, at the closing date and time of bid.
d. Medicines offered by bidders must be registered in terms of section 15 of the Medicines and Related Substances Act, Act 101 of 1965 as amended, and bidders must indicate on the item response field the registration number of such an item in terms of the said Act. The medicines must comply with the conditions under which the medicine is registered at the closing date and time of bid. Certified copies of product registration certificates with the MCC should accompany the bid at closing date and time.
e. The bidder must submit proof of current GMP compliance of all manufacturing, packing and laboratory sites used for each product and disclose any notice of deviation from GMP received from the MCC.
f. The bidder must submit a certified copy of a valid certificate of Registration as a Responsible Pharmacist with the South African Pharmacy Council.
Special Conditions of Contract – HP08SSP/02
9.3 NON COMPLIANCE
Non compliance with the above mentioned (Paragraphs 9.1 and 9.2) special
conditions may invalidate the bid for such products offered
10. CONTRACT ADMINISTRATION
a. Successful bidders must advise the Cluster Manager: Pharmaceutical Policy
and Planning immediately when unforeseeable circumstances will adversely
affect the execution of the contract. Full particulars of such circumstances as
well as the period of delay must be furnished within a week of identifying such
a problem.
b. The administration and facilitation of the contract will be the responsibility of
National Department of Health and all correspondence in this regard must be
directed to one of the following addresses:
Director: Affordable Medicines
Department of Health
Private Bag X828
PRETORIA 0001
Director: Affordable Medicines Civitas Building Room 501 South Tower 242 Struben Street
PRETORIA 0002
c. The Department of Health may communicate with bidders where clarity is
sought after the closing date of the bid and prior to the award of the contract, or
to extend the validity period of the bid, if necessary.
d. All communication between the bidder and the Department of Health must be
done in writing.
e. Any communication to any government official or a person acting in an advisory
capacity for the Department in respect of this bid between the closing date and
the award of the bid by the bidder is discouraged.
Special Conditions of Contract – HP08SSP/02
11. COUNTER CONDITIONS
Bidders’ attention is drawn to the fact that amendments to any of the Bid Conditions or
setting of counter conditions by the bidders may result in the invalidation of such bids.
12. FRONTING
a. The National Department of Health supports the spirit of broad based black
economic empowerment and recognizes 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.
b. 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 ten years, in addition to any other
remedies the National Department of Health may have against the bidder /
contractor concerned.
13. PRODUCT COMPLIANCE
13.1 PRE AWARD PRODUCT COMPLIANCE PROCEDURES
The following pre-award product compliance procedures will apply:
Special Conditions of Contract – HP08SSP/02
a. Compliance to specifications as stated in the bid document.
b. Certified copy of product registration with Medicines Control Council (MCC)
where applicable
c. Compliance to Good Manufacturing Practice where applicable
d. Valid relevant licence from Medicines Control Council where applicable
e. Submission of samples of the relevant products on or before the closing date
and time of the bid at the addresses indicated in paragraph 13.2.
13.2 SAMPLES
a. No samples must be sent to the Pharmaceutical Policy and Planning unit of
the National Department of Health.
b. Samples must be submitted to each of the addresses indicated below, to be
received before or at closing date and time of bid:
Ms Santie Van Dyk
Tel: 011 628 9003
Gauteng: Medical Supplies Depot
Store 3
35 Plunkett Avenue
Hurst Hill 2092
Ms Helen Hayes
Tel: 021 483 4567
Western Cape: Department of Health
Pharmaceutical Services
4 Dorp Street Room T14-02
Cape Town 8001
c. For accurate evaluation of samples, bidders must submit in original packaging at
least the following minimum quantities:
� Powders in sachets: 5 sachets of powder
� All other dosage forms – at least one original pack
d. Bids not supported by samples will be disregarded in respect of the items for
which samples are not submitted.
e. Samples of items offered must be marked with the bid number, the item number
as well as the bidder’s name and address.
Special Conditions of Contract – HP08SSP/02
f. It is the responsibility of the bidders to ensure receipt of the samples at the testing
authorities described in section 13.2 (b).
g. Samples submitted by unsuccessful bidders must be collected by them within 3
months of the commencement of the contract. Samples not collected within this 3
month period will be destroyed.
h. Samples of all products accepted against this bid will be retained for the duration
of the contract period.
i. All samples must be a true representation of the product which will be supplied.
j. All samples of registered medicines must be submitted with the MCC
approved/registered package insert.
14. PRICE QUALIFICATION AND CONTRACT PRICE ADJUSTMENT PROCEDURE
14.1 PRICING STRUCTURE
a. Prices submitted for this bid will be regarded as non-firm and subject only to
adjustment(s) in terms of the formula under paragraph 14.2, defined areas of cost
and defined periods of time.
b. Bidders should quote a final delivered price.
c. Final price must include API price, formulation cost, transport cost, Value Add Tax,
etc. Bidders are referred to the pricing schedule in this regard.
d. Bidders should note that margins above cost cannot be adjusted.
14.2 PRICE ADJUSTMENTS
a. The Department of Health reserves the right to accept or reject any application for
price adjustment.
b. Bidders are required to complete the price breakdown in the relevant response
fields as per diagram below. Failure to provide such breakdown may exclude the
bidder from any price adjustments during the contract period.
Special Conditions of Contract – HP08SSP/02
Cost component
(For fully imported or finished products offered
from another manufacturer, API and
formulation components may be combined)
% of total product value
(values in this column must add up
to 100%)
Value
(Value for “% imported” and “% local” must add up to
100% for each cost component)
% imported
% local
API
Formulation cost
Transportation cost
N/a
Margin
N/a
N/a
c. Applications for price adjustments must be accompanied by documentary
evidence in support of any adjustment.
d. The process for price adjustment will be as follows:
� Identify the cost component(s) to be adjusted. Margins above cost
cannot be adjusted, thus eligible cost components include:
o Cost of the API
o Costs related to formulation
o Costs related to transport
� Calculate price adjustment using the following formula:
RA1 RF1 RT1
Pa = Pt DA RA0 + DF RF0 + DT RT0 + PM
Pa
=
The new price to be calculated
Pt
=
Original award price. Note that Pt must always be the original award price
DA
=
The proportion of the award price attributable to API cost
Special Conditions of Contract – HP08SSP/02
RA1
=
New cost of the API
RA0
=
Base cost of the API
DF
=
The proportion of the award price attributable to formulation cost
RF1 = The new cost of formulation
RF0 The base cost of formulation
DT The proportion of the award price attributable to transport cost
RT1 The new cost of transport
RT0 The base cost of transport
PM
The proportion of the award price that is attributable to margin above cost; this variable is not adjustable
e. Costs associated with normal business risk are not eligible for adjustment, but
unforeseen costs that may impact continuous supply will be considered.
f. Applications for price adjustments may be submitted by the half-yearly review dates
stipulated in section 14.3 and must be accompanied by documentary evidence of
the circumstances that are claimed to warrant a price adjustment.
g. Information required to assess price adjustment requests is as follows:
� For adjustments related to API price changes, suppliers must submit the following: o Documentation of the current cost of the API o Documentation of the new cost of the API
� For adjustments related to formulation or transport price changes, suppliers must submit the following: o A description of why the adjustment is necessary o Documentation of the current cost of the cost component o Documentation of the new cost of the cost component
h. Successful bidders can apply for adjustments relating to one or more than one combination of the above factors.
Special Conditions of Contract – HP08SSP/02
i. Contracted suppliers are expected to continue to supply the product without interruption at the contracted price until advised of the outcome of a price adjustment application.
j. No retroactive price increases will be permitted for purchase orders already issued to and accepted by the manufacturer.
k. Where the Department of Health is not satisfied with the documentation submitted, it could grant a lower adjustment or deny the request altogether.
l. All requests for price adjustments will be based on the original award price – and not on any previously adjusted price.
m. Should the Department of Health choose to initiate a price adjustment (decrease) for a particular product, the following factors will be taken into account to determine the revised prices:
� Material reductions in the cost of the API, as determined by a composite index of API costs linked to international prices for products in question;
� Feasibility of using an alternate source if a cheaper source of APIs is available at the requisite quality level;
� Time needed to implement necessary changes in raw material or API sources as determined by regulatory processes mandated by the MCC and other regulatory bodies in question;
� Other material reductions in the cost of Production based on changes in technology or alternate routes of production becoming available or substantially higher volumes than anticipated resulting in a drop in fixed manufacturing costs.
14.3 PRICE ADJUSTMENT PERIODS
Adjustment to contract prices may be applied for at the following dates:
Adjustment
Application for price adjustment to reach the office by the following dates
Dates from which adjusted prices will become effective
1st Adjustment 5 December 2013 1 January 2014
14.4 RATES OF EXCHANGE (RoE) – BASE AND AVERAGE RATES
In the event where material and/or finished products are imported the following will
apply:
a. The formula described in par. 14.2 will be used and ONLY the imported cost
component of the bid price will be adjusted taking into account the base RoE and
the average RoE rate over the period under review indicated in paragraph (d)
below.
b. Rate(s) of exchange to be used in this bid in the conversion of the price of the
item(s) to South African currency.
Currency Rates of exchange Average for the period 1 May 2012 to 31 July 2012
US Dollar
R 8.2757
Pound Sterling
R 13.0114
Euro
R 10.4748
Yen
R 0.1042
c. Should the bidder make use of any other currency not mentioned above, the bidder is requested to calculate the average for the period 1 May 2012 to 31 July 2012 using the South African Reserve Bank published rates for the specific currency. Visit www.reservebank.co.za to obtain the relevant rates.
d. Contract price adjustments due to rate of exchange variations are based on average exchange rates as published by the Reserve Bank for the periods indicated hereunder:
Adjustment
Average exchange rates for the period:
1st Adjustment 1 June 2013 – 30 November 2013
14.5 GENERAL
a. Unless prior approval has been obtained from National Department of Health, no
adjustment in contract prices will be made.
b. Contract Price Adjustment (CPA) applications will be applied strictly according to
the specified formula and variables above as well as the cost breakdown supplied
by successful bidders in their bid documents.
c. In the event where the supplier’s CPA application, based on the above formula and
parameters, differs from National Department of Health’s verification, National
Department of Health will consult with the supplier to resolve the differences.
d. Bidders are referred to paragraph 11 of the Special Conditions regarding counter
conditions.
e. An electronic price adjustment calculator will be made available on the Department
of Health’s website and will be communicated.
15. QUANTITIES, ORDERS AND DELIVERY
15.1 DELIVERY ADHERENCE
a. For each product, bidders must explicitly indicate the minimum and maximum
volumes that they can supply on a monthly, quarterly (3-monthly) and annual basis
on the response fields.
b. Ability to supply must be maintained throughout the duration of the contract.
c. Bidders must indicate and provide assurance of ability to maintain delivery lead time
(time from placement of the order to delivery at the provincial medical store or
delivery point) of less than 6 weeks for the duration of the contract.
d. Delivery of products must be made in accordance with the instructions appearing on
the official order forms emanating from the above mentioned Participating
Authorities and institutions placing the orders.
e. All deliveries or dispatches must be accompanied by a delivery note stating the
official order number against which the delivery has been effected.
f. In respect of items awarded to them, contractors must adhere strictly to the delivery
periods quoted by them in their bids.
g. The instructions appearing on the official order form regarding the supply, dispatch
and submission of invoices must be strictly adhered to.
h. All invoices should be delivered / posted to reach the institution that placed the
order timeously. The invoices should be original and accompanied by proof of
delivery.
i. Deliveries must be in accordance with official orders and any deviation will be
returned to the contractor at the contractor’s expense.
j. Deliveries must conform to cold chain distribution requirements, if applicable.
Normal storage conditions (25 degrees Celsius) must not be exceeded.
15.2 QUANTITIES AND ORDERS
a. The ordered quantities are required for delivery as indicated by the particular
participating departments.
b. Suppliers should under no circumstances deviate from the orders issued by the
departments.
c. The Department of Health is under no obligation to purchase any stock, which is in
excess of the indicated quantities for any item.
d. The quantity indicated against each item represents the total estimated off-take of
all participating departments as per paragraph 4.
e. Bidders should note that the order/s will be spread out throughout the contract
period and that delivery points will be to the individual Provincial Depots or
institutions.
f. Bids must be for supply ex duty paid stocks held in the Republic of South Africa
during the contract period.
g. The quantities reflected in the bid documents are estimated quantities and no
guarantee is given or implied as to the actual quantity which will be ordered.
h. The Department of Health also reserves the right to purchase its requirements
elsewhere outside the contract in terms of clause 21 of the General Conditions of
Contract if:
� Minimum order quantity specified by the contractor be more than that of an institution’s requirements
� The item(s) are urgently required and not immediately available � An emergency arises � If the contractor fails to perform in terms of this contract
i. The Department of Health reserves the right to arrange contracts with more than
one contractor for the same item but not exceeding three contractors subject to the
following condition:
� In a split or multiple awards a single bidder will not be awarded more than one portion for the same line item.
� The Department of Health reserves the right not to split award amongst bidders using the same API source and / or manufacturer.
j. The allocation of volumes between two suppliers will be determined based on the
difference in points, as follows:
Category
Difference between points
Recommended percentage split
A
Equal points
50/50
B
0,1% – 5 %
60/40
C
5,1% - 10%
70/30
D
10,1% – 20 %
80/20
k. The Department of Health reserves the right to determine the number of awards per
line item.
l. For multiple awards of the same item to three bidders the volume will be allocated
according to the following formula in line with paragraph 15.2 k:
Supplier portion = [1/N * 100]% + [Supplier score – Mean score] * 2.3 %
where N= the number of bids accepted.
m. The Department of Health reserves the right to change drug regimens and/or
product formulations if necessary due to emerging clinical evidence, disease
profiles, reported adverse drug reactions or resistance patterns.
15.3 MANUFACTURING INFORMATION
a. Bidders must disclose the manufacturing site(s) as well as the API supplier(s), as
approved by or submitted to the MCC.
b. Bidders must be able to substantiate the API price provided.
16. PACKAGING
a. All deliveries made against this contract whether by road or rail are to be packed in
containers, which will be acceptable for further dispatch by rail. Attention is drawn
to the requirements of the Transnet Fright Rail Standard Conditions of Carriage
Policy.
b. The number of “PACK” items in the commercial packing must appear on the bid
documents. The packing must be uniform for the duration of the contract period,
i.e.:
� The number of “PACK” items per commercial packing.
� The number of commercial packing per carton.
� The number of cartons per bulk packing.
� The conditions under which the product must be stored.
c. The following information must be clearly and indelibly printed on all inner and outer
bulk packing in letters not less than 10mm in height:
� Name and strength of item and quantity
� Date of manufacture.
� Expiry date.
� Batch number.
17. LABELS AND PACKAGE INSERTS
Labels and package inserts for medicines intended for administration to humans, must comply with the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended.
18. CONTAINERS
The function of a container for a medicinal preparation is to maintain the quality,
safety and stability of its contents. Containers should withstand the mechanical
hazards of handling and transport, prevent leakage, and provide an appropriate
level of protection from environmental conditions. Conditions of container must be
acceptable to purchaser at the point of delivery. Ideally, the materials of
construction should have no chemical or physical effect on the preparation, and, for
liquid preparations, should be sufficiently transparent to permit inspection of the
contents whilst providing protection from incident radiation when necessary.
19. STERILITY
a. All preparations are to be supplied sterile and apyrogenic.
20. BARCODES
a. It is a specific condition of all pharmaceutical bids that the packaging of all products supplied to the Department of Health must include a barcode (number plus symbology). Both the outer case and the specification pack must be marked with the appropriate number and symbology. The European Article Numbering Code 13 (EAN 13) has been accepted as standard. The batch number and the expiry date should be included in the barcode, if possible.
b. Bidders who are already in possession of the necessary block of numbers are requested to submit the EAN 13 numeric code(s) for each of the products offered as well as the outer case coding applicable to the distribution pack(s) (ITF 14) together with the quantity of items contained in such packs.
21. INSPECTION AND ASSAY
a. A valid certificate of analysis per batch, not older than two years from date of issue,
must accompany every delivery of raw materials when requested.
b. All deliveries to authorised participants will be subject to a visual examination and
scrutiny by the relevant participant and/or assay by the Laboratories as indicated in
paragraph 13.2 (g)
22. QUALITY
a. Products supplied in consequence of this bid must conform in every respect with
the conditions of registration lodged with Medicines Control Council and where
applicable, the relevant SABS or EU standards throughout the period of the
contract.
23. SHELF-LIFE
a. Products, upon delivery, must have at least 18 months of shelf-life before date of
expiry.
b. Any delivery of short dated supplies without prior written approval must be collected
by the respective suppliers at their own cost.
c. Contractors may make written applications to deliver material with a shorter shelf-
life, provided such applications are accompanied by an undertaking that such short-
dated stock will be unconditionally replaced before or after expiry and that such
applications are approved before execution of the orders.
d. Provided also that any such written application must include an undertaking by the
contractor to apply the following discount formula when supplying short dated stock:
A = 2(18 – months to date of expiry) % X consignment value short dated stock.
Therefore, amount to be invoiced is: Consignment value – A, where A is the
discount formula.
e. Any participating authority may, without prejudice, decline written applications to
deliver stock with a shelf -life of less than 18 months.
24. POST AWARD
24.1 MERGERS AND TAKE OVERS
a. Where a contracted supplier merges with or is taken over by another, the
Department of Health must be informed of such plans immediately. See contact
details in paragraph 24.2 below.
b. Documentation in paragraph 9 above pertaining to the new company must be
submitted to the Department of Health
c. The Department of Health reserves the right to agree to transfer of contractual
obligations to the new supplier under the prevailing conditions of contract or to
cancel the contract.
24.2 MONITORING
The contractors must confirm compliance with the Good Manufacturing Practice.
Any change in the said status during the contract period must be reported within
seven (7) days of receipt of such notice from the Medicines Control Council to:
Pharmaceutical Policy and Planning, Affordable Medicines, Department of Health,
for attention:
Dr. Anban Pillay
Acting Cluster Manager: Pharmaceutical Policy & Planning
Tel No: 012 395 8170
Ms. Helecine Zeeman
([email protected]) Director: Affordable
Medicines Tel. No: 012 395 8530
Ms Phuti Moloko
([email protected]) Deputy Director:
Procurement & Distribution
Tel. No: 012 395 8439
25. REPORTING AND HISTORICAL DATA
25.1 HISTORICAL DATA
Historical value and volume reports are required to be submitted monthly
preferably via e-mail to the Department of Health for attention of Ms P Moloko
([email protected]), Ms M Rasengane ([email protected]) and Ms N
Scheurkogel ([email protected]) by all successful bidders. For this purpose
electronic templates which will include orders received and deliveries made will be
supplied to successful bidders.
10th of each month.
The reports must be submitted on or before the
25.2
PERFORMANCE MEASURES
25.2.1 a.
b.
SUPPLIERS MEASURES
Delivery period adherence
Product quality adherence
25.2.2 a.
END USER MEASURES
On time payment
26. CONTACT DETAILS
Chief Directorate: Pharmaceutical Policy and Planning, Private Bag x 828, Pretoria,
0001 or Physical address: 242 Struben Street, Civitas Building, Pretoria, 0001.
Bid Enquiries:
Phuti Moloko:
Tel: (012) 395 8439
Fax: (012) 395 8823
Specification / Technical Enquiries Mamma Rasengane
Tel: (012) 395 9452
Fax: (012) 395 8823 [email protected]
