CONTRACT NUMBER: HM01-2012CNDM SUPPLY AND …Northern Cape Ms Masego Mothlaudi Mr Paul Moasokwane (053) 830 0517 (053) 830 0655 Western Cape Ms Juanita Arendse Ms Maniekan Dveshana

Enquiries:

IDepartn"lent:HealthREPUBLIC OF SOUTH AFRICA

Private Bag X828, PRETORIA, 0001. Civitas Building ,Cnr Thabo Sehume & Struben Streets, PRETORIA 0001Directorate: Affordable MedicinesTel: (012) 395 8130 Fax: (012) 395 8823/4

Ms P Moloko Ref: HM01-2012CNDM Tel: (012) 395 8439 Fax:(012) 395 8823e-mail: [email protected] Fax to e-mail: 086 594-8899

CONTRACT NUMBER: HM01-2012CNDMSUPPLY AND DELIVERY OF MALE AND FEMALE CONDOMS TO THE DEPARTMENT OF

HEALTHPERIOD: 1 DECEMBER 2012 TO 30 NOVEMBER 2014

1. The attached contract circular for your information.

2. This contract will be subject to the General Conditions of Contract issued in accordance withChapter 164 of the Treasury Regulations published in terms of the Public Finance ManagementAct, 1999 (Act 1of 1999). The Special Conditions of Contract are supplementary to that of theGeneral Conditions of Contract. Where, however, the Special Conditions of Contract are inconflict with the General Conditions of the Contract, the Special Conditions of Contract willprevail.

3. The following Departments of Health will participate in this contract:

H ZEEMAN\ \ -H s-t {p-e---

DIRECTOR: AFFORDABLE MEDICINESFoT: DIRECTOR.GENERAL HEALTHDATE: aq . \\ . 2- o \->

PARTICIPANTS CONTACT PERSON TEL NO FAX NO

National Ms BE Marumo (012) 395 9142 (086) 529 0997

Eastern Caoe Dr Margaret NtlangulaMs Thandeka Peter

(040) 608 1757(040) 609 3943

(040) 609 3660

Free State Mr Sam BolemeMr Pitso Makheta

(051) 408 1429( 0 5 1 ) 4 0 8 1 1 1 9

(051) 408 1961(051 ) 409 8493

Gauteng Dr Zuki PininiMs Nomvula Nvandeni

(011) 355 3384/3334340813421

(01 1) 355 3338 t 3297(086) 61 0 2012

KwaZulu-Natal Dr Thami MayiseMs Thuli Buthelezi

(033) 341 4001(033) 341 4015

(033) 3940287

Limpopo Ms Eva KobolaMr Elias Diketane

(083) 395 4724(01 5) 293 6000

(015) 293 6184

Mpumalanga Ms ThokozileMr Lucas Nkosi

(013) 766 3418 (013) 766 3470

North West Ms Smangele NtombelaMr Koketso Tlatsana

(018) 397 2601 (018) 397 2600

Northern Cape Ms Masego MothlaudiMr Paul Moasokwane

(053) 830 0517 (053) 830 0655

Western Cape Ms Juanita ArendseMs Maniekan Dveshana

(021) 483 9881 (021) 483 9921

2

HM01-2012CNDM: SUPPLY AND DELIVERY OF MALE AND FEMALE CONDOMS TO THE DEPARTMENT OF HEALTHFOR THE PERIOD 1 DECEMBER 2012 TO 30 NOVEMBER 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 and are on a delivered basis. 1.3 Suppliers should take careful note of the delivery address requested on each

order and should ensure that invoices and signed proof of delivery are received by the ordering authority.

1.4 Note that both suppliers and provincial contact persons will be required to report

monthly to the National Department of Health on the status of all orders placed in terms of this contract.

1.5 Should an order be placed by any institution other than the provincial contact

persons listed above, the validity of the order must first be confirmed with the relevant provincial contact persons.

1.6 Please note that each of the suppliers listed below should be registered on the

supplier database of each provincial department of health.

1.7 Contact persons and e-mail addresses indicated hereunder are to be used for contract enquiries and not for orders.

2. NAMES AND ADDRESSES OF CONTRACTORS AND CONTACT DETAIL

Supplier Name Supplier Address Contact Detail

----------------------------- Telephone Number Fax Number

Contact Person E-mail Address

AMM Management Solutions

P O Box 1963 PINETOWN 3600

Tel: 031 811 7843 Fax: 086 647 1801

Ayanda P Ntombela [email protected]

Bliss Pharmaceuticals (Pty) Ltd

P O Box 604 RIDGEWAY 2099

Tel: 011 496 3255 Fax: 011 496 3264

Kingsley Tloubatla [email protected]

Bonga Trading cc P O Box 884 New Germany KWAZULU-NATAL 3610

Tel: 086 199 1114 Fax: 086 539 1246

Bonga Mlambo [email protected]

Kohrs Medical Supplies P O Box 6070 ZIMBALI 4418

Tel: 032 947 2592/3 or 4Fax: 086 211 7435

Vera Marion Kohrs [email protected]

Liyama Consultants cc 71 Honeysuckle Velden Vlei RICHARDS BAY 3900

Tel: 082 456 0206 Fax: 086 647 1991

Nonqubeko Zwane [email protected]

SA Health Protecting Services cc

P O Box 201809 DURBAN NORTH 4016

Tel: 031 569 1641 Fax: 031 569 1516

Sibusiso Lushaba [email protected]

Sakhiwo Health Solutions (Mpumalanga) (Pty) Ltd

P O Box 1841 BROOKLYN SQUARE 0075

Tel: 012 346 2923 Fax: 086 622 9222

Dr Nomsa Dlamini / Johann Loubser [email protected]

Sekunjalo Investments Corporations (Pty) Ltd

P O Box 7348 ROGGEBAAI 8012

Tel: 021 531 6601 Fax: 021 531 6729

Joseph Lionel Morris [email protected]

HM01‐2012CNDM CONTRACT CIRCULAR: SUPPLY AND DELIVERY OF MALE AND FEMALE CONDOMS TO THE DEPARTMENT OF HEALTH

Item No Description Quantity Awarded

(Packs of 200 condoms)

Split Brand Name

Supplier Name Unit Price Unit Pack Lead Time (days)

Total Score

National Stock Number

1 1,101,900 16.95% Choice Bonga Trading CC R 48.22 200 45 93.45

Single condoms:1,050,400 16.16% Choice SA Health Protecting

Services ccR 45.90 200 30 90.00 180131888 [EA]

932,500 14.35% Choice Kohrs Medical Supplies (Pty) Ltd

R 54.00 200 10 82.12

Packs of 200787,100 12.11% Choice Sekunjalo Investments

Corporation R 59.98 200 10 72.39 181804873 [CO]

698,000 10.74% Choice AMM Management Solutions

R 62.00 200 66.43

697,100 10.72% Choice Liyama Consultants CC R 62.03 200 10 66.37

652,300 10.03% Choice Bliss Pharmaceuticals (Pty) Ltd

R 63.56 200 30 63.37

580,700 8.93% Choice Sakhiwo Health Solutions (Mpumalanga) Pty Ltd

R 64.47 200 5 58.59

Male condomsPack of 200

Full specification in Annexure A

PERIOD: 1 DECEMBER 2012 ‐ 30 NOVEMBER 2014 Page 1 of 1

ANNEXURE A

Item 1: Male Condoms Detailed Specification

South African Department of Health Male Latex Condom Specification: 2012-2014

LATEX MALE CONDOM SINGLE USE

PROCUREMENT SPECIFICATION

1. GENERAL REQUIREMENTS Manufacturers and Suppliers shall follow an appropriate code of quality management, including good manufacturing practices (GMP) as required by the South African Bureau of Standards (SABS) Mark Scheme and statistical process control, in the manufacture and packaging of condoms. The methods used to test for compliance are: use of statistical samples; and subjective inspection; and documentary evidence, such as comprehensive reports of stability tests, certificates of purity from

material suppliers, or certification by regulatory agency or an independent body. Requirements marked with a star/* will be tested on each lot and will be seen as critical to the fulfilment of the tender agreement. The remaining requirements will be tested on a random basis. Should any of the condoms not meet the requirements when tested that particular lot will be considered to be unfit for delivery and therefore in breach of the tender agreement and will be subject to the conditions held therein. 1.1 Constituent materials The condoms shall be made from natural rubber latex. The latex shall be free of embedded solid impurities and discoloration. The condoms shall not liberate toxic or otherwise harmful substances in amounts that can be

irritating, sensitising or otherwise harmful to the user of the condom under normal conditions of use. The compounding materials (colouring agents, antioxidants, accelerators, vulcanizing agents and

other additives) shall not have a deleterious effect on the condoms, nor shall they have a harmful or irritating effect on the human body. The use and type of accelerators used should be stated. Excess accelerators and other leachable chemicals should be avoided.

Careful attention shall be given in the formulation to suitable antioxidants in order to provide

maximum protection under adverse storage conditions. All materials must comply strictly with the requirements of the applicable portions of the US Code of

Federal Regulations (USCFR) 21 and/or latest updated version. These requirements will be verified by documentary evidence.


1.2 Shelf-life Condoms shall comply with the performance requirements of this specification throughout the stated shelf life of the condom. It is intended that condoms purchased under this specification should retain their properties when exposed in their individual packages to an average temperature of 350 C for the stated shelf-life. The manufacturer shall stipulate a shelf-life, measured from the month of manufacture, during which the packed products will be stable in properties, and will continue to meet the requirements of clause 2.1. (before oven conditioning). This shelf-life shall be at least 5 years. At the time of delivery at least 80% of the shelf-life must still be available to the procurer. The manufacturer shall make available to the purchaser on request, data to support the stated shelf-life. This data may take the form of: 1. Real time stability studies conducted over the stated shelf-life at 35o C 2. Accelerated studies conducted over shorter times at higher temperatures. These should

preferably be done at 70o C at multiple intervals over 21 days and at a temperature between 40o C and 50o C, at multiple intervals (e.g. every 2 weeks), for at least 6 months. The basis for any extrapolation to real environmental temperatures should be stated,

3. Use of the methods of ISO 11346. The maximum acceptable decrease in mean inflation properties should be 25%, and products should comply with the requirements in clause 2.1. at the end of the stated shelf-life. Updated documentation on 350 C post-market trials must be made available to the purchaser on request. Validated expiry dates up to 5 years will be allowed. 1.3 Resistance to oxidation (independent of the package) (i) Sampling One hundred (100) condoms per lot (ii) Testing Remove the condoms from their packages. Place the rolled condoms in an oven at 70 + 20 C. After 2 days, remove 50 condoms from the oven, allow them to cool for 12-96 hours and test them by air inflation according to ISO 4074. After a further 7 days, remove the remainder from the oven and test them as above. (iii) Requirement The ratio of the mean burst pressure at 9 days to the mean burst pressure at 2 days should not be less than 75%


1.4 Dressing materials The dressing materials applied to the condoms (e.g. powders and lubricants) shall not have a deleterious effect on the condoms, nor shall they have a harmful or irritating effect on the human body. These materials shall comply strictly with the requirements of the applicable portions of the US Code of Federal Regulations (USCFR) 21 or its equivalent. The manufacturer shall use a suitable powder (e.g. cornstarch; silica, magnesium carbonate) to improve the "feel" of the condom and facilitate unrolling. Talc and lycopodium spores shall not be used. Documentary evidence is required to verify the quality of the dressing materials. 2 PERFORMANCE REQUIREMENTS Condoms purchased under this specification must not leak or break during use, and must retain their properties when exposed in their individual packages to average temperatures of 350 C at maximum humidity for the stated shelf-life. Performance requirements will be tested for compliance by the use of statistical samples and prescribed

test protocols. Tests or verifications in this section will generally be undertaken at the pre-qualification stage, and by

lot-by-lot compliance testing carried out by the purchaser’s laboratory or by a third party laboratory selected by the purchaser prior to delivery.

Unless otherwise indicated, test protocols will be according to ISO 4074 (version current at the time of

contract). 2.1 Bursting volume and pressure* (i) Sampling For the test before oven conditioning: ISO 2859-1 General Inspection Level G-1. For the test after oven conditioning: 80 condoms per lot. (The purpose of this test is to check for major formulation or vulcanisation errors.) (ii) Testing In accordance with the inflation test and oven conditioning procedure in ISO 4074, Annexure G and the relevant clause in ISO 4074.


(iii) Requirement Before ageing, AQL 1.0% applied separately to volume and pressure non-compliers. The minimum permitted bursting volume depends on the width of the condom. For the test before oven conditioning, the specification prescribes a minimum limit for each condom tested. The minimum bursting pressure shall be 1kPa. The minimum volume is arrived at by the following formula: minimum limit (litres) = w2 (rounded off to the nearest 0.5 litres) 150 The width is the lot mean width of a sample of 13 condoms, rounded off to the nearest 0.5 mm, of the shank portion of the condom measured 70 + 5 mm determined in accordance with ISO 4074. After oven conditioning, neither the mean bursting pressure nor the mean bursting volume shall diminish by more than 20%. 2.2 Freedom from holes* (i) Sampling ISO 2859-1 General Inspection Level G-1, but at least code level M. (ii) Testing The test is carried out in accordance with ISO 4074, Annexure L. Condoms breaking or tearing as a result of prescribed handling will be considered failures. (iii) Requirement AQL 0.25. 2.3 Package integrity* (i) Sampling ISO 2859-1 Special Inspection Level S-3.

(ii) Testing

In accordance with Package Integrity Test Method in ISO 4074 Annex M Sample condoms in individual packages are placed in an airtight, transparent container (such as a laboratory Bell jar) and subjected to a vacuum of 90 + 5 kPa (gauge) for a period of one minute. Condom packs should inflate and remain inflated for the period of the test. Packs that do not inflate or do not remain inflated are considered to be non-compliers. It is permissible to repeat the test on any packs not giving a clear result. (iii) Requirement AQL 2.5%


3 DESIGN REQUIREMENTS The purchaser, as part of the purchase agreement or before delivery of the product, must approve any variances in these properties. The methods used to test these requirements for compliance will be:

visual inspection; or the use of statistical samples and prescribed test protocols.

Tests or verifications in this section will generally be:

at the pre-qualification1 stage; compliance lot-by-lot testing carried out by the purchaser’s laboratory or by a third-party

laboratory selected by the purchaser prior to delivery; periodic audits other than the mandatory lot by lot testing if the quality of the product is in doubt

once it has been purchased. Unless otherwise indicated, test protocols will be according to ISO 4074 (version current at the time of contract). 3.1 Shape and texture* The surface of the condoms shall be smooth throughout. The condoms shall have straight and parallel sides, without constrictions, and with a visible shoulder leading to a reservoir pouch at the tip. 3.2 Bead* The open end of the condom shall have a rolled ring of latex, called an integral bead. 3.3 Colour and clarity The condoms shall be translucent (clear) and without added colouring 3.4 Odour and taste The condoms shall be odourless to the degree approved by the purchaser at pre-qualification. The condoms shall not give off an unpleasant odour when the package is opened at any time after manufacture and for the shelf life of the product. (Condoms have a characteristic odour of rubber, which tends to dissipate quickly once the package is opened)

1 Pre-qualification is the process, which proceeds the tender during which the supplier provides condoms for testing and other appropriate

documentation according to the requirements of this specification to gain entry in to the tender.


The manufacturer or the manufacturer’s agent will store 100 condoms for at least one year at room temperature from each certified lot2 for use in resolving disputes regarding odour. The condoms shall be free from taste. 3.1 – 3.4 verify by visual and other appropriate inspection methods 3.5 Length* (i) Sampling According to ISO 2859-1 Special Inspection Level S-2. (ii) Testing According to the length measurement procedure in ISO 4074 Annexure D (iii) Requirement A minimum of 180 mm allowed. 3.6 Width* (i) Sampling According to ISO 2859-1 Special Inspection Level S-2. (ii) Testing According to the width measurement procedure in ISO 4074 Annexure E (iii) Requirement A width of 53 mm with a tolerance of ± 2 mm is allowed for individual condoms with an AQL of 1.0% and in addition a tolerance of ± 1 mm for the mean of the lot. 3.7 Thickness* (i) Sampling ISO 2859-1 Special Inspection Level S-2. (ii) Testing In accordance with test method in ISO 4074 annex F The measurement of thickness is done with a micrometer mounted on an anvil, with resolution of at least 0,002 mm, operating with a pressure of 22 + 4 kPa on the sample.

2 A certified lot is a lot of condoms, which has been tested and found to meet the requirements in this specification by the procurer’s testing

agents.


For convenience, the double-wall thickness may be measured and divided by two. The samples should be wiped once with absorbent tissue, inside and out, before measuring. The thickness measurements are taken at three points: 30 + 5 mm from the open end, 30 + 5 mm from the closed end (excluding the reservoir tip), and at the mid-distance between those two points. The individual measurements, and the average of all three, are recorded for each sample. (iii) Requirement AQL 1% The mean single-wall thickness (calculated from the three individual measurements) for each condom shall be 0.065 ± 0.015 mm. 3.8 Quantity of lubricant * (i) Sampling ISO 2859-1 Special Inspection Level S-2. (ii) Testing In accordance with test method in ISO 4074, Annex C The condoms in their packages are weighed on an analytical balance. The packages are then opened and the condoms removed. The condoms and packages are washed in denatured ethanol or isopropanol until all lubricant is removed, dried to a constant mass, and then weighed again. All weights shall be recorded to the nearest milligram (mg). The weight of lubricant and dressing material will be the difference in weight of the condom and package before and after washing. Washing and drying may be repeated up to a total of four times if necessary to assure complete removal of lubricant. Alternatively, an ultrasonic bath may be used for washing, provided the washing time has been validated against repeated manual washing. For initial validation of either method, weighing is conducted after each drying. (iii) Requirement The quantity of silicone lubricant, including powder, in the package shall be 550 + 150 mg. With an AQL of 4.0%. The viscosity of the silicone lubricant shall be between 200 and 350 centistokes at manufacture. 3.9 Individual package materials and markings* (i) Sampling ISO 2859- Special Inspection Level S-3.


(ii) Testing The sample of condom packages is visually inspected to verify the required aspects of package quality. Any lot numbers on packages must be printed at the time of packaging - not pre-printed. In addition, the following shall apply:

There shall be no evidence of leakage. The outside surface of the package shall be clean. There shall be no separation of the layers of laminate. Sealed packages are in strips of up to 4, the individual packages are separated by perforations or other

means which allow the packages to be separated by hand without interfering with the seals. The package must be easy to open and will have a notch or serration to assist in opening. The packages shall have the following indelible markings:

Manufacturer’s name lot or lot identification code (printed at the time of packaging, not pre-printed); Manufacturing date: Month and year- labelled Manufacturing Date Expiry Date: month and year of expiry labelled in full or Exp Date abbreviated in English (the year

shall be written as a four digit number, and the month as a two digit number);

Requirement AQL 2.5%. Verify by visual inspection 4. PACKAGING FOR DELIVERY REQUIREMENTS The properties listed below will be tested for compliance by inspection. Inspections or verifications in this section will generally be carried out at the pre-qualification stage, lot-by-lot compliance testing and during periodic inspections/ audits. 4.1 Cartons and markings

(i) Sampling ISO 2859-1 Special Inspection Level S-3. The lot size for the inspection of inner boxes or consumer packs is the number of inner boxes, and the sample unit is one inner box. For the inspection of exterior shipping cartons, the lot size is the number of exterior shipping cartons, and the sample unit is one shipping carton. Examination of inner boxes shall be done on boxes selected at random from sample shipping cartons. Examination of defects of closure shall be done on randomly selected shipping cartons fully prepared for delivery.


(ii) Testing By inspection carried out at the time of sampling and/or testing. (iii) Requirements The individual requirements for the various packagings and packing for delivery are set out below. The AQL for these inspections is 2.5%. Defects found in the packaging and the marking of packages for delivery shall be assessed in accordance with the following table:

Classification of defects in packaging and marking of packages for delivery

Examine Defects Contents Number of condoms not as specified; packages or strips not as

specified. Marking Omitted; incorrect; illegible; of an improper size (exterior,

interior), location, sequence, or method of application. Materials Packaging/packing materials not as specified, missing, damaged

or non-serviceable. Workmanship Shipping cartons inadequately closed and secured; poor

application of internal packaging and packing material; distorted intermediate packages.

Exterior Shipping Cartons Thirty dispenser boxes will be packed into plastic waterproof lining bags, which will be placed into three-wall corrugated fibreboard cartons (in three layers of ten dispenser boxes each) made from weather-resistant fibreboard with a bursting strength of not less than 1900 kPa. The carton flaps shall be secured with water-resistant adhesive applied to not less than 75% of the area of contact between the flaps or with 75-mm-wide water-resistant tape applied to the full length of the centre seams and extending over the ends not less than 75 mm. The cartons will be secured by plastic strapping at not less than two positions. Alternatively, wire-bound, cleated plywood or nailed wood boxes are acceptable when lined with a waterproof barrier material. The barrier material must be sealed at the edges with waterproof tape or adhesive, and there must be no sharp protrusions inside the boxes. The exterior shipping carton, like the bulk carton, shall be marked on the exposed face with information about the contents in a clearly legible manner. The information shall include: Lot or lot identification number. Month and year of manufacture (including the words Date of Manufacture, Month, Year) in English.

The year shall be written as a four-digit number, and the month as a two-digit number.


Month and year of expiry (including the words Expiry Date, Month, Year) in English. The year shall

be written as a four-digit number, and the month as a two-digit number. Name and address of contractor. Nominal width. Number contained in the carton. Instructions for storage and handling. 4.2 Lot traceability To facilitate monitoring of LOT quality during shipping and storage, all exterior-shipping cartons for each discrete LOT shall be assembled and shipped together. Best efforts shall be made to ensure that shipments remain as discrete LOTS and that these LOTS remain intact as far down the distribution system as possible. These efforts may include the use of very large lettering for LOT codes on the exterior shipping cartons, colour coding, palleting of discrete LOTS or otherwise physically linking all exterior shipping cartons from discrete lots, and issuing instructions to this effect to shippers and warehouse personnel. Each LOT or LOT identification code shall start with the suppliers four digit SABS mark holder registration number followed by a three letter contractor identifier, followed by a unique lot number e.g. 1234/ABC/030001.


5.0 Summary of requirements for which tests are specified

Specification # Sampling Testing Requirements AQL GENERAL REQUIREMENTS 1

Constituent materials 1.1 Documentation

Shelf-life 1.2 3 lots/650 each see

Specification 1.2

Documentation

Resistance to oxidation

1.3 100 condoms see

Specification 1.3

P (9 days) - P (2days) < 25%

PERFORMANCE REQUIREMENTS 2

Bursting volume 2.1 G-1* ISO 4074

see

Specification 2.1

width2/150 1.0

Bursting volume 700C/7 days

2.1 80 condoms ISO 4074 <20% drop

Bursting pressure 2.1 G-1* ISO 4074 1kPa 1.0

Bursting pressure 70°C/7 days

2.1 80 condoms ISO 4074 <20% drop

Freedom from holes 2.2 G-1* ISO 4074

see

Specification 2.2

<3 holes 0.25

Package integrity 2.3 S-3* see

Specification 2.3

<3 leaks 2.5

DESIGN

REQUIREMENT 3

Length 3.5 S-2* ISO 4074 >=180 mm 1.0

Width 3.6 S-2* ISO 4074 53 ± 2 mm; mean

52 ± 1 mm

1.0

Thickness 3.7 S-2* see

Specification 3.7

0.065 ± 0.015 mm 1.0

Lubricant plus Powder

3.8 S-2* See

Specification 3.8

550 ± 150 mg 4.0

PACKAGING

REQUIREMENT

4

Package Materials and Markings

4.1 S-3* see

Specification 3.9

Specification 4.1

Visual Inspection 2.5

Special Requirements and Conditions of Contract HMO1-2012CNDM

SUPPLY AND DELIVERY OF MALE AND FEMALE CONDOMS

TO THE DEPARTMENT OF HEALTH FOR THE PERIOD

1 DECEMBER 2012 TO 30 NOVEMBER 2014

VALIDITY PERIOD 120 DAYS National Department of Health

Special Requirements and Conditions of Contract-HM01-2012CNDM

2

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 ..............................................................................................6

9. AUTHORISATION DECLARATION AND LEGISLATIVE REQUIREMENTS .............................7

9.1 DECLARATION OF AUTHORISATION .....................................................................................7

9.2 DOCUMENTATION OF UNDERTAKING AND LEGISLATIVE REQUIREMENTS ...................7

9.3 NON COMPLIANCE ..................................................................................................................8

10. CONTRACT ADMINISTRATION ................................................................................................8

11. COUNTER CONDITIONS ...........................................................................................................9

12. FRONTING .................................................................................................................................9

13. PRODUCT COMPLIANCE..........................................................................................................9

13.1 PRE AWARD PRODUCT COMPLIANCE PROCEDURES .......................................................9

14. PRICE QUALIFICATION AND CONTRACT PRICE ADJUSTMENT PROCEDURE ................10

14.1 PRICING STRUCTURE ...........................................................................................................10

14.2 PRICE ADJUSTMENTS ..........................................................................................................10

14.3 PRICE ADJUSTMENT PERIODS ...........................................................................................14

14.4 RATES OF EXCHANGE (ROE) – BASE AND AVERAGE RATES .........................................14

14.5 GENERAL................................................................................................................................15

15. QUANTITIES, ORDERS AND DELIVERY ................................................................................15

15.1 DELIVERY ADHERENCE .......................................................................................................15

15.2 QUANTITIES AND ORDERS ..................................................................................................16

15.3 MANUFACTURING INFORMATION .......................................................................................17

16. SAMPLES .................................................................................................................................18

17. STANDARDS FOR TESTING OF SAMPLES ..........................................................................19

18. LABELLING ..............................................................................................................................20

19. CONTAINERS ..........................................................................................................................20

20. BARCODES ..............................................................................................................................20

21. INSPECTIONS ..........................................................................................................................20

22. QUALITY ...................................................................................................................................21

23. PERFORMANCE REQUIREMENTS ........................................................................................21


3

24. SHELF LIFE ..............................................................................................................................21

25. MANUFACTURING INFORMATION ........................................................................................21

26 PACKAGING ...........................................................................................................................21

27 POST AWARD PRODUCT COMPLIANCE PROCEDURES ..................................................22

28 COMPLIANCE TESTED STOCK LEVELS ...................................................................... .......23

29 POST AWARD MONITORING ND USER MEASURES .........................................................24

30. REPORTING AND HISTORICAL DATA .................................................................................25

30.1 HISTORICAL DATA ...............................................................................................................25

31 PERFORMANCE MEASURES ............................................................................................ 25

31.1 SUPPLIER MEASURES................................................................................................ ........25

3I.2 END USER MEASURES........................................................................................................ 25

32 CONTACT DETAILS.............................................................................................................. 25


4

1. SPECIAL CONDITIONS OF CONTRACT This bid and all contracts emanating there from 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)

Broad Based Black Economic Empowerment (B-BBEE) status level of contributor

(maximum 10 points)

b. The following formula will be used to calculate the points for price:

Ps = 90

minmin1

P

PPt

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 B-

BBEE status level of contributor in accordance with the table below:


5

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. Should two or more bids be equal in all respects, the award will be decided by the

drawing of lots.

j. A contract may, on reasonable and justifiable grounds, be awarded to a bid that did

not score the highest number of points.

k. The Department of Health reserves the right to negotiate prices.

l. The Department of Health reserves the right not to award a line item.


6

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 commencing 1 December

2012 to 30 November 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

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.


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9. AUTHORISATION DECLARATION AND DOCUMENTATION OF UNDERTAKING

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.

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 DOCUMENTATION OF UNDERTAKING AND 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.


8

b. With respect to the female condom, the bidder must supply complete documentation

indicating that the product offered has World Health Organisation (WHO) Female

Condom Technical Review Committee recommendation

c. Bidders must comply with legal requirements.

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 Medicine

Department of Health

Postal: Private Bag X828 Pretoria 0001

Physical: Room 501 South Tower 242 Struben Street Pretoria 0001

and

Director: HIV & AIDS and STI’s Prevention Strategies

Department of Health

Postal: Private Bag X828 Pretoria 0001

Physical: Room 501 North Tower 242 Struben Street Pretoria 0001

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.


9

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.

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:

a. Compliance to specifications as stated in the bid document.

b. Compliance certificates.


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c. A copy of the complete documentation “SABS permit to Apply Certificate Mark” ,

(i.e not a face sheet but all additional documentation including the precise

manufacturing process(es) that the certificate mark applies to).

d. A copy of complete documentation of World Health Organization (WHO) Female

Condom Technical Review Committee recommendation as relevant.

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 16.

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. Prices quoted must be furnished on the basis of “delivered into store” country-wide

d. Bids must be for the supply ex duty paid stocks held in the Republic of South Africa

during the contract period.

e. Prices quoted must be per unit as per specification of each item as advertised.

f. Prices submitted for this bid must be entered on the relevant fields on the bid

response document.

g. Price structures that do not comply with this requirement may invalidate the bid.

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.


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Cost component

(For fully imported or finished products offered from another manufacturer, materials and

manufacturing 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

Cost of raw materials

Manufacturing

cost

Labour

Other

Transportation

cost

Fuel N/a

Freight

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 raw materials

o Costs related to manufacture (labour and other)

o Costs related to transport (fuel and freight)

Calculate price adjustment using the following formula:

PMRR D

RRD

RR D

RR D

RR DPtPa

F0

F1F

T0

T1T

M0

M1M

L0

L1L

A0

A1A

Pa = The new adjusted price to be calculated

Pt = Original bid price. Note that Pt must always be the original bid price and not an adjusted price

DA = The proportion of the award price attributable to raw materials

RA1 = New cost of raw materials


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RA0 = Base cost of raw material

DL = The proportion of the award price attributable to labour

RL1 = New cost of labour

RL0 = Base cost of labour

DM = The proportion of the award price attributable to manufacturing costs - other

RM1 = New cost of manufacturing costs - other

RM0 = Base cost of manufacturing costs - other

DT = The proportion of the award price attributable to fuel

RT1 = New cost of fuel

RT0 = Base cost of fuel

DF = The proportion of the award price attributable to freight

RF1 = New cost of freight

RF0 = Base cost of freight

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:


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For adjustments related to raw material price changes, suppliers must submit the following: o Documentation of the current cost of the raw materials o Documentation of the new cost of the raw materials o Supplier / Manufacturer invoice(s) and remittance advice(s)

For adjustments related to manufacturing 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 o Relevant local indices (e.g. Stats SA PPI or transport index) will only be

considered regarding applicable declared local content. h. Successful bidders can apply for adjustments relating to one or more than one

combination of the above factors. 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 raw materials, as determined by a composite index of raw materials linked to international prices for products 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.

Known substantial drops in international freight or fuel prices.

n. The applicable index refers to the relevant market index, which is a true

reflection of price movement(s) in the cost over time. The base index date

applicable to the formula is defined as a date at which the price adjustment starts. In

this bid the base index date is February 2012.


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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 November 2012 1 December 2012

2nd Adjustment 5 May 2013 1 June 2013

3rd Adjustment 5 November 2013 1 December 2013

4th Adjustment 5 May 2014 1 June 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 December 2011 to 29 February 2012

US Dollar R 7.9407

Pound Sterling R 12.4175

Euro R 10.4080

Yen R 0.1022

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 December 2011 to 29 February

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:


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1st Adjustment 1 March 2012 - 31 October 2012 2nd Adjustment 1 November 2012 - 30 April 2013 3rd Adjustment 1 May 2013 – 31 October 2013 4th Adjustment 1 November 2013 - 30 April 2014

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 in the response fields the

minimum and maximum volumes that they can supply on a monthly, quarterly (3-

monthly) and annual basis

b. Sufficient stocks must be stored in a warehouse in South Africa to meet delivery

requirements as per paragraph 28. 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 identified delivery point) for the

duration of the contract in compliance with paragraph 28.

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.


16

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 the purchaser’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


17

i. The Department of Health reserves the right to arrange contracts with more than

one contractor for the same item but not exceeding ten contractors subject to the

following condition:

In a split or multiple award 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 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 or more 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 invite bids on supplementary tender

should it be necessitated by developing circumstances.

15.3 MANUFACTURING INFORMATION

Bidders must disclose the manufacturing site(s) as well as suppliers of raw material.

Bidders must be able to substantiate their bid price.

16. SAMPLES

a. Do not submit samples to the National Department of Health.


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b. Where a standard is indicated, a sample must be submitted for testing to SABS

before the closing date and time of bid. The purpose is to obtain a test report for the

items being offered in the bid.

c. 1200 pieces per batch of male condoms and 1200 pieces per batch of female

condoms including sampling certificate from accredited independent sampling

organisation must be submitted for testing before the closing date and time of the

bid.

d. Proof from the SABS of submission of samples must be submitted with the bid at

the closing date and time of bid

e. Samples will not be accepted after the closing date and time of bid.

f. Test reports must be submitted with the bid at closing time and date of bid proving

that the relevant item(s) complies with the specification after inspection and testing

of the samples by SABS.

g. In the event that a test report cannot be obtained from the testing institution prior to

the closing date and time of the bid, the bidder must obtain proof (issued by the

testing institution) that the sample had been submitted to the testing institution for

testing before or on the closing date and time of the bid. Such proof must be

submitted with the bid at closing date and time of the bid. Failure to provide such

proof may invalidate the bid.

h. All bidders, including current contractors, are required to submit samples.

i. Condom samples will be evaluated for design and performance criteria in

compliance with product specifications and World Health Organisation standards.

No evaluation of foil design and packaging will be carried out prior to the closure of

the bid.

j. It is imperative that samples of all items offered be submitted for evaluation.

k. During the bidding process bidders are accountable for the cost of testing.

l. Samples to be submitted at the address indicated below:

South African Bureau of Standards

1 Dr Lategan Road

Groenkloof

Contact Person: Ms Isabella Masemola

Tel: (012) 428 6131

n. Marking of samples for submission to testing institutions should be done according

to the following requirements:

Samples must be placed in suitable containers and be clearly marked on the

outside with the bid number(s), and the bidder’s name.

Branding is not required for samples submitted for testing.


19

Failure to comply with this condition may invalidate the bid against the relevant item.

17. STANDARDS FOR TESTING OF SAMPLES a. Items must comply with standards as stated in the bid documents.

b. South African Bureau of Standards:

SANS, SABS, ISO AND CKS specifications are available from South African Bureau

of Standards Office’s countrywide. Obtaining such specifications will be the

responsibility of and for the accounts of the prospective bidder. To purchase

standards, obtain quotes or enquire about the availability of eStandards, please

contact Standards Sales at:

Postal Address: Private Bag X191, Pretoria, 0001

Physical Address: 1 Dr Lategan Road, Groenkloof, Pretoria

Tel: (012) 428 6883, Fax: (012) 428 6928, E-mail: [email protected]

Website: www.sabs.co.za and follow the “Search/Buy Standards” link

c. South African National Accreditation System (SANAS):

The contact details of SANAS are as follows:

Postal Address: Private Bag X23, Sunnyside, Pretoria, 0132

Physical Address: The DTI Campus, 77 Meintjies Street,

Sunnyside, Pretoria, 0002,

Tel: (012) 394 3760, Fax: (012) 394 0526

A list of institutions is available on the SANAS website

http://222.sanas.co.za/ or http://www.sanas.co.za/contact.php

d. Manufacturers and suppliers of male and female condoms shall follow an

appropriate code of quality management, including good quality management

system as required in the manufacturing and packaging of condoms. Condoms

should be designed and produced in accordance with good quality management

system ISO 14971 and ISO 1348.

e. Bidders should contact SABS to obtain a copy of the sampling frame guidelines

prior to the submission of samples. All bidders must arrange random sampling in

accordance with the SABS sampling frame guidelines at the point of packaging of

the finished products. Sampling must be carried out by an independent or

internationally recognised organisation. A list of approved agencies can be


20

obtained from SANAS. Samples must be taken from production lots produced at

the source factory within the preceding 30 days from the date of sampling. Samples

must be submitted to the SABS for batch testing which will be performed according

to National Department of Health / World Health Organisation standards and

specifications. All lot sizes for testing shall be between 144 000 and 288 000

pieces.

18. LABELLING

Labelling shall be performed in accordance with specification of products in

Annexures A and B

19. CONTAINERS

The function of a container is to maintain the quality, safety and stability of its

contents. The condition of container must be acceptable to purchaser at the point of

delivery. The materials of construction should have no chemical or physical effect

on the product. Containers should withstand the mechanical hazards of handling,

transport and storage, prevent leakage and provide appropriate level of protection to

the environmental conditions or contact with metal.

20. BARCODES a. 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 the 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. INSPECTIONS a. The purchaser, as part of the purchase agreement and before delivery of the product,

must approve any variance in the properties for compliance with specification

requirements in Annexure A and Annexure B


21

b. Packaging will be tested for compliance by inspection. Inspections or verifications will

generally be carried out at the pre-qualification stage, lot-by-lot compliance testing and

during periodic inspections / audits.

22. QUALITY

Quality assurance requirements of condoms shall comply with those indicated in the

products specification in Annexures A and B.

23. PERFORMANCE REQUIREMENTS

Performance requirements of condoms shall comply with those indicated in the


24. SHELF-LIFE The shelf life requirements of condoms shall comply with those indicated in the

products specification in Annexures A and B and shall be as follows:

For male condoms it shall be five (5) years.

For female condoms it shall be three (3) years.

A minimum of 80% of the shelf life of condoms shall be available to the purchaser at

the time of delivery.

25. MANUFACTURING INFORMATION a. Bidders must disclose the manufacturing site(s)

b. Any intention to change the condom manufacturing source prior to the

commencement of the contract or during the lifetime of the contract must be

approved by the Bid Adjudication Committee, National Department of Health.

26. PACKAGING a. Packaging requirements of condoms shall comply with those indicated in the


b. All deliveries made against this contract, in all modes of transport, are to be packed

in suitable containers, which will be acceptable for further dispatch.


22

c. Packaging requirements of condoms shall comply with those indicated in the


d. All deliveries made against this contract, in all modes of transport, are to be packed

in suitable containers, which will be acceptable for further dispatch.

e. The packing of the goods to be supplied must be uniform for the duration of the

contract period, i.e.

The number of units per commercial packing

The number of commercial packing per carton

The number of cartons per bulk packing

The name and quantity of the contents and expiry date if applicable must

appear clearly on the packing

All containers, packing and cartons must be clearly labelled

f. All products must be packed in acceptable containers, where applicable, specifically

developed for the products.

27. POST AWARD PRODUCT COMPLIANCE PROCEDURES Consignment/Batch Testing

a. All contractors must arrange random sampling (Sampling frame according to SABS

guidelines) at the point of packaging of the finished products. Sampling must be

carried out by an independent or internationally recognised organisation. A list of

approved agencies can be obtained from SANAS. Samples must be taken from

production lots produced at the source factory within the preceding 30 days from the

date of sampling. Samples must be submitted to SABS for batch testing which will

be done according to National Department of Health / World Health Organisation

standards and specifications

The particulars for SANAS as in 17b above.

b. The contractors shall before the confirmation of orders and issue of delivery site

quantities and delivery dates, provide the STI & HIV Aids Prevention unit of the

Department of Health with compliance certificates proving adherence to the

specification for each batch prior to shipment from the manufacturer.

c. Copies of these certificates must also accompany the proof of delivery

documentation submitted for payment.


23

d. At the time of sampling the sampling agent will require certified documentation from

the manufacturer indicating batch size of every batch sampled.

e. Sampling and testing organisations appointed by the Department of Health shall

carry out all these certification tests.

f. The cost of these tests shall be borne by the Department of Health. The cost of

tests in the event of failure of batches will be for the account of the contractor.

g. Test results are final and no requests for testing by other testing laboratories will be

entertained by the Department of Health. Any performance failure (water, airburst,

package seal integrity tests) will result in immediate and non-negotiable rejection of

the batch.

h. Any cases of minor design failures will be treated on a case-by case basis taking

into account the needs of the programme in relation to the particular failure.

However, if an application for concession is made by a contractor and subsequently

granted by the Department of Health, all testing costs for the concession batches

will be borne by the contractor.

i. All lot sizes for testing shall be between 1000 and 2000 gross (i.e. between 144 000

and 288 000 pieces). All lot sizes must be certified at the time of sampling and this

information must be communicated by the contractor to the Department of Health as

soon as possible after certification. A lot is a single grade, class and composition

manufactured under essentially the same conditions. All condoms comprising a lot

will:

Have an identical formulation.

Have the same dimensions, shape, colour and texture

Be manufactured on the same production line

Be vulcanised under identical conditions

Be manufactured within a period of 24 hours

Not be made up of separate interrupted runs

j. With respect to the female condoms the supplier must submit complete

documentation on the in-house manufacturing level, quality assurance programme

in place at the point of manufacture. This will include descriptions of sampling and

testing protocols, equipment in use including place of manufacture, date

commissioned and calibration schedules and procedures. Original compliance test

reports for every production batch (including tensile (cross-sectional seam), air


24

inflation (measuring peak pressure) and water leakage tests), duly certified by

senior management must be provided at the time of sampling.

28. COMPLIANCE TESTED STOCK LEVELS

a. Contractors will be required to have in-country, and immediately available for

delivery, at least two month's compliance certified stock at the commencement date

of the contract and this minimum stock level must be maintained through the end of

quarter seven of the contract. (Stock level estimated from the anticipated

requirements of the procurer and as indicated in the contract award unless

otherwise instructed in writing by the procurer). This stock level requirement for

compliant product may be adjusted by the Department of Health to respond to

changing programmatic requirements.

b. Suppliers will be expected to deliver condoms according to delivery schedules

issued periodically by the Department of Health against current compliant stock

levels to any or all of 150-200 sites within the country. Delivery quantities shall

generally range from 60 000 to 2000 000 condoms per male condom site and 5 000

to 60 000 condoms per female condom site. Once the delivery sites and quantities

list is issued to suppliers, deliveries shall be made within ten working days. To the

extent possible for male condoms, the procurer will serve sites utilizing stock

available in the nearest proximity.

The supplier must inform delivery sites by phone at least 24 hours in advance as to

when they should expect a delivery. Deliveries must be made within reasonable

working hours, before 15:00 on week days. Delivery staff must ensure all cartons

are stacked neatly, with all labels right side up, in the respective storage areas. It

will be the supplier’s responsibility to ensure that adequate material offloading

labour is provided. Delivery site staff is not obliged to assist with the materials

offloading.

29. POST AWARD MONITORING

Any change in the status in supply performance during the contract period must be

reported within seven (7) days of receipt of such information:

Pharmaceutical Policy and Planning, Affordable Medicines, Department of Health, and

Cluster: HIV & Aids and STI’s: Prevention Strategies for attention:


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Dr Thobile Mbengashe ([email protected]) Cluster: HIV & Aids and

STI’s: Prevention Strategies

Tel. No: 012 395 9157

Ms Thato Chidarikire ([email protected])

Cluster: HIV & Aids and STI’s: Prevention Strategies

Tel. No: 012 395 9153

Ms Eva Marumo ([email protected])

Cluster: HIV & Aids and STI’s: Prevention Strategies

Tel. No: 012 395 9142

30. REPORTING AND HISTORICAL DATA

30.1 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 E Marumo

([email protected]), Ms B May ([email protected]) and Ms A Sithole

([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. The reports must be submitted on or before the 10th of each

month.

32. PERFORMANCE MEASURES

31.1 SUPPLIERS MEASURES

a. Delivery period adherence

Product quality adherence

31.2 END USER MEASURES

On time payment

33. CONTACT DETAILS Chief Directorate: Pharmaceutical Policy and Planning, Private Bag X828, Pretoria,

0001 or Physical address: 242 Struben Street, Civitas Building, Pretoria,0001.

Bid Enquiries:


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Phuti Moloko Tel: (012) 395 8439 Fax: (012) 395 8823 [email protected]

Babalwa May: Tel: (012) 395-8442 Fax: (086) 632 9951 [email protected]

Specification / Technical Enquiries :

Eva Marumo Tel: (012) 395-9142 Fax: (086) 632 8758 [email protected]

Sample Enquiries Isabella Masemola South African Bureau of Standards Tel: 012 428 6131

e-mail: [email protected]

Documents

CONTRACT NUMBER: HM01-2012CNDM SUPPLY AND …Northern Cape Ms Masego Mothlaudi Mr Paul Moasokwane (053) 830 0517 (053) 830 0655 Western Cape Ms Juanita Arendse Ms Maniekan Dveshana