17 cetirizine dihydrochloride 5mg/5ml syrup, 150ml 111 000 cipla medpro south africa (pty) ltd vxz32...

HP12-2014LQ: SUPPLY AND DELIVERY OF PHARMACEUTICAL LIQUIDS TO THE DEPARTMENT OF HEALTH CONTRACT CIRCULAR PERIOD: 1 OCTOBER 2014 TO 30 SEPTEMBER 2017

Page 1 of 4

Item No Description Quantity Awarded

Bidder Name Supplier Code Brand name Delivered Price in ZAR Unit Pack Shipper Pack Lead Time (21 Days)

MOQ Total Score National Stock Number

UOM

1 ACETIC ACID, GLACIAL B.P., 500ml 3 300 Noko Healthcare cc V2PK3 Protea Chemicals R 44.9000 1 24 14 24 98.00 18-971-4840 BT2 ACETONE B.P., 500ml 24 300 Noko Healthcare cc V2PK3 Protea Chemicals R 42.9300 1 24 14 24 98.00 18-971-4841 BT3 ACRIFLAVINE/PROFLAVINE 0,1% m/v emulsion, 100ml 42 400 Resmed Healthcare cc VCEJ2 Resmed Acriflavine Emulsion R 13.6800 100ml 1 x 100 x 100ml 21 100 x 100ml 100.00 18-971-3765 BT

4 ACRIFLAVINE/PROFLAVINE 0,1% m/v emulsion, 500ml 24 100 Resmed Healthcare cc VCEJ2 Resmed Acriflavine Emulsion R 38.7600 500ml 1 x 24 x 500ml 21 24 x 500ml 100.00 18-970-7408 BT

6 ALCOHOL, ethanol content at 15,56°C V/V % minimum 96%, 500ml

500 Noko Healthcare cc V2PK3 Protea Chemicals R 39.2400 1 24 14 24 98.00 18-177-4104 BT

7 ALCOHOL, ethanol content at 15,56°C V/V % minimum 96%, 20 litre

11 600 Barrs Pharmaceuticals (Pty) Ltd

V4890 Barrs Alcohol 96.1% R 475.8455 20L 1 x 20L 21 1 99.00 18-177-4538 CO

9 ALCOHOL, 70% Surface Spray Disinfectant, 70% v/v Ethanol 4.2% v/v Isopropyl Alcohol, 500ml

104 000 Sanichem (Pty) Ltd VZRX2 Cavicide 50 R 14.3000 1 24 14 70 98.00 18-189-7182 BT

12 BENZOIN TINCTURE, COMPOUND B.P., 20ml 142 600 Barrs Pharmaceuticals (Pty) Ltd

V4890 Barrs Benzoin Tincture Comp. BP R 5.8872 20ml 384 21 384 99.00 18-971-4844 BT

13 BENZOIN TINCTURE, COMPOUND B.P., 100ml 22 900 Barrs Pharmaceuticals (Pty) Ltd

V4890 Barrs Benzoin Tincture Comp. BP R 26.0900 100ml 120 21 120 99.00 18-970-7410 BT

14 BENZYL BENZOATE 25% emulsion, 100ml 774 200 Pharmachem Laboratories (Pty) Ltd

V3LA8 Benzyl Benzoate Application BP R 2.8842 100ml 100 21 500 98.00 18-970-7445 BT

15 CALAMINE LOTION B.P., 100ml 4 733 200 Barrs Pharmaceuticals (Pty) Ltd

V4890 Barrs Calamine Lotion BP R 2.6448 100ml 120 21 120 99.00 18-970-3365 BT

16 CARBAMAZEPINE 100mg/5ml suspension, 250ml 155 600 Novartis South Africa (Pty) Ltd

VBVW2 Tegretol S R 119.7000 1 800 21 1 93.00 18-971-2347 BT

17 CETIRIZINE DIHYDROCHLORIDE 5mg/5ml syrup, 150ml 111 000 Cipla Medpro South Africa (Pty) Ltd

VXZ32 Allecet Syrup R 7.8400 1 20 21 20 99.00 18-189-4020 BT

18 CETRIMIDE 15% and CHLORHEXIDINE GLUCONATE 1,5% solution, 5 litre Coloured yellow

21 500 Dismed Pharmaceutical (Pty) Ltd

VBKK5 Cetidine Concentrate 5LCODE 0501302

R 226.9100 5000ml 4 per box 21 4 x 5000ml 93.00 18-971-1309 CO

19 CHLORHEXIDINE GLUCONATE 0.2% mouthwash solution, 100ml

1 483 100 Resmed Healthcare cc VCEJ2 Resmed Chlorhexidine Gluconate R 3.6366 100ml 1 x 100 x 100ml 21 100 x 100ml 100.00 18-179-8227 BT

20 CHLORHEXIDINE GLUCONATE 0,2% mouthwash solution, 200ml

56 500 Resmed Healthcare cc VCEJ2 Resmed Chlorhexidine Gluconate R 5.2896 200ml 1 x 50 x 200ml 21 50 x 200ml 100.00 18-971-4848 BT

21 CHLORHEXIDINE GLUCONATE 0,5% in ALCOHOL 70% solution with emollient, For use as a hand disinfectant. Tinted green 500ml


V4890 Sterisol R 14.9852 500ml 20 21 20 99.00 18-177-5871 CO

22 CHLORHEXIDINE GLUCONATE 0,5% in ALCOHOL 70% solution with emollient, For use as a hand disinfectant. Tinted green 5L

240 400 Sanichem (Pty) Ltd VZRX2 Sanigel R 105.0000 1 4 14 10 98.00 18-971-4845 CO

23 CHLORHEXIDINE GLUCONATE 0.5% in ALCOHOL 70% solution for use as a skin disinfectant Without emollient, Coloured red 50ml


VBKK5 Biotaine 0.5% in 70% ALC 50mlCODE 0501295

R 3.6500 50ml 200 per box 21 200 minimum 93.00 18-186-1509 BT

24 CHLORHEXIDINE GLUCONATE 0.5% in ALCOHOL 70% solution for use as a skin disinfectant Without emollientColoured red 100ml

7 800 Sanichem (Pty) Ltd VZRX2 Sanitane R 7.2000 1 50 14 136 98.00 18-010-2624 BT

25 CHLORHEXIDINE GLUCONATE 0.5% in ALCOHOL 70% solution for use as a skin disinfectant Without emollient, Coloured red 500ml

1 511 000 Dismed Pharmaceutical (Pty) Ltd

VBKK5 Biotaine 0.5% in 70% ALC 500mlCODE 0501291(Offer 1)

R 14.1400 500ml 20 per box 21 20 x 500ml 93.00 18-009-0749 BT

26 CHLORHEXIDINE GLUCONATE 0.5% in ALCOHOL70% solution for use as a skin disinfectant Without emollient, Coloured red 2.5L


VBKK5 Biotaine 0.5% in 70% ALC 2.5LCODE 0501550(Offer 1)

R 53.0100 2500ml 4 per box 21 4 x 2500ml 93.00 18-191-8453 BT

27 CHLORHEXIDINE / ALCOHOLDispenser spray pump to fit a 500ml bottleTo fit 500ml bottle: Items 21 & 25


V4890 Barrs Spray Pump R 2.8829 1 20 21 20 99.00 18-188-1981 EA


Page 2 of 4




UOM

28 CHLORHEXIDINE GLUCONATE 4% solution, For use as a surgical scrub 5L


VBKK5 Bioscrub 5LCODE 0501298

R 153.8400 5000ml 4 per box 21 4 x 5000ml 93.00 18-000-9972 CO

29 CHLORHEXIDINE GLUCONATE 4% solution, For use as a surgical scrub 500ml Series with pump: Item 30

2 711 400 Dismed Pharmaceutical (Pty) Ltd

VBKK5 Bioscrub 500ml with Pump CODE 0501297P(Offer 2)

R 21.6600 500ml 20 per box 21 20 x 500ml 93.00 18-970-5153 BT

31 CHLORHEXIDINE GLUCONATE 5% solution, Tinted red 5L


VBKK5 Biotaine 5% Concentrate 5LCODE 0501347

R 217.3900 5000ml 4 per box 21 4 x 5000ml 93.00 18-971-2105 CO

32 CHLORHEXIDINE GLUCONATE 8mg and BENZYDAMINE 22,5mg / 15ml mouthwash solution, 200ml

99 900 Inova Pharmaceuticals (Pty) Ltd

V2192 Andolex-C Oral Rinse R 33.2400 200ml bottle 200ml bottles x 20 14 1 bottle 91.00 18-025-7846 BT

33 CHLOROQUINE SULPHATE 68mg equivalent to CHLOROQUINE BASE 50mg/5ml syrup, 100ml

1 800 Mirren (Pty) Ltd V7149 Mirquin Syrup R 25.4400 100 ml 25 7 25 units 90.00 18-970-6003 BT

34 CHLORPHENIRAMINE MALEATE 2mg/5ml syrup, 50ml 13 325 900 Adcock Ingram Healthcare (Pty) Ltd

V2272 Allergex Elixir 50ml R 2.8700 1 x 50ml 50 21 50 (1 shipper)

98.00 18-971-1414 BT

35 CLONAZEPAM 2,5mg/ml oral drops, 10ml dropper bottle 5 400 Roche Products (Pty) Ltd V2177 Rivotril Drops 2,5mg/ml R 79.8000 1x 10ml bottle 264 bottles per shipper

21 1 bottle 92.00 18-971-1400 BT

36 COAL TAR solution B.P., 500ml 28 400 Resmed Healthcare cc VCEJ2 Resmed Coal Tar Solution BP R 33.9720 500ml 1 x 24 x 500ml 21 9 x 500ml 100.00 18-971-2370 BT43 DIPHENHYDRAMINE HCl 10mg - 14mg and AMMONIUM

CHLORIDE 125mg - 140mg/5ml syrup,100ml 9 183 900 Barrs Pharmaceuticals (Pty)

LtdV4890 Relief-Coff Expectorant R 1.9786 100ml 120 21 120 99.00 18-970-5079 BT

44 DIPHENHYDRAMINE HCl 7mg and AMMONIUM CHLORIDE 68.5mg / 5ml syrup, 100ml

2 655 000 Resmed Healthcare cc VCEJ2 Teens Cherry Cough Syrup R 2.6220 100ml 1 x 100 x 100ml 21 100 x100ml 100.00 18-191-8459 BT

45 EMOLLIENT LOTION, 200ml To be labelled for external use

19 900 Medivision (Pty) Ltd V20D5 Emollient Lotion, 200 ml R 6.1600 1 x 200ml 80 21 80 99.00 18-971-4645 BT

46 ENZYMATIC CLEANER FOR SURGICAL INSTRUMENTS, Multi-purpose, presoak and cleaner containing amylase and protease enzymes. Able to remove all organic soil and debris containing protein, lipids and starches.Suitable for manual cleaning ultrasonic washers and automated cleaning of medical appliances / surgical instruments, including endoscopes. Neutral pH. Manufacturer to submit ISO9001 certificate. Concentrated. Use dilution to be stated 2,5 - 5 litre bottle

9 500 Sanichem (Pty) Ltd VZRX2 Sanizyme R 311.0000 1 x 3.8L 4 14 2 x 4 98.00 18-191-9462 CO

47 ENZYMATIC CLEANER FOR SURGICAL INSTRUMENTS, Multi-purpose, presoak and cleaner containing amylase, lipase and protease enzymes. Able to remove all organic soil and debris containing protein, lipids and starches.Suitable for manual cleaning ultrasonic washers and automated cleaning of medical appliances / surgical instruments, including endoscopes. Neutral pH. Manufacturer to submit ISO9001 certificate. Concentrated. Use dilution to be stated. 2,5 - 5 litre

11 400 Sanichem (Pty) Ltd VZRX2 Sanizyme R 311.0000 1 x 3.8L 4 14 2 x 4 98.00 18-097-0906 CO

49 ERGOCALCIFEROL (VIT D) 5000 units/ml oral drops in suitable vegetable oil, 15ml dropper bottle

227 700 Pharmacare Limited V2205 Calciferol Oily Soln 15ml R 51.1632 15ml 144 x 6 x 15ml 21 12 98.00 18-971-2409 BT

50 ETHER, Technical, In accordance with the regulations of the Occupational Health and Safety Act, 1993 (Act 85 of 1993) and Hazardous Substances Act, 1973 (Act 15 of 1973)500ml

1 200 Noko Healthcare cc V2PK3 Protea Chemicals R 50.0000 1 24 14 24 98.00 18-177-4548 CO

52 FERROUS GLUCONATE 350mg / 5ml equivalent to Elemental Iron 40mg/5ml syrup, 100ml

1 354 100 Barrs Pharmaceuticals (Pty) Ltd

V4890 Barrs Ferrous Gluconate Syrup R 6.9467 100ml 120 21 120 99.00 18-007-9580 BT


Page 3 of 4




UOM

53 FERROUS LACTATE 77,328mg equivalent to Elemental Iron 15mg/0.6ml drops, 10ml bottle with calibrated dropper packed as a unit in a cardboard box

337 800 Pharmacare Limited V2205 Ferro Drops L Solution 10ml R 47.0820 10ml 120 x 10 x 10ml 21 10 98.00 18-971-1476 BT

54 FORMALDEHYDE SOLUTION B.P., 1 litre 2 900 Noko Healthcare cc V2PK3 Protea Chemicals R 46.1600 1 24 14 24 98.00 18-970-0822 LI55 FORMALDEHYDE SOLUTION B.P., 2.5 litre 4 400 Medivision (Pty) Ltd V20D5 Formaldehyde, 2.5 L R 98.3300 1 x 2.5 L 6 x 2.5 L 21 12 99.00 18-971-1664 CO56 FUROSEMIDE 10mg/ml solution, 100ml bottle with

calibrated dropper 42 900 Sanofi Aventis South Africa

(Pty) LtdV18F3 Lasix Oral Solution R 213.3000 1 bottle of 100ml 75 bottles of 100ml 21 1 Shipper pack

(75 Bottles)94.00 18-971-4763 BT

57 GENTIAN VIOLET 0,5% or 1% solution, 20ml plastic bottle with non-spill dropper type neck


V4890 Barrs Gentian Violet Soln. 0.5% R 1.5896 20ml 384 21 384 99.00 18-971-2405 BT

60 GLYCERIN, B.P., 500ml 4 800 Pharmachem Laboratories (Pty) Ltd

V3LA8 Glycerin BP R 31.3158 500ml 24 21 96 98.00 18-971-5124 BT

61 GLYCERIN, BP, 2-5 - 3L 1 400 Pharmachem Laboratories (Pty) Ltd

V3LA8 Glycerin BP R 90.6072 2,5L 6 21 60 98.00 18-186-1429 BT

62 GLYCO-THYMOL COMPOUND mouthwash B.P., 100ml 1 773 000 Pharmachem Laboratories (Pty) Ltd

V3LA8 Glyco Thymol Co R 2.2230 100ml 100 21 500 98.00 18-971-2406 BT

63 HALOTHANE U.S.P., 250ml 5 500 Safeline Pharmaceuticals (Pty) Ltd

VZL63 Halothane U.S.P250ml

R 373.6100 1 36 21 144 99.00 18-975-0285 BT

64 HYDROGEN PEROXIDE B.P., 6 % solution, 20 volumes, 500ml

56 800 Resmed Healthcare cc VCEJ2 Resmed Hydrogen Peroxide Solution 20 Vol

R 6.4182 500ml 1 x 24 x 500ml 21 24 x 500ml 100.00 18-970-0824 BT

66 IBUPROFEN 100mg/5ml suspension, 100ml 1 083 600 Pharmaceutical Contractors (Pty) Ltd

VCJF7 Ibucine 100mg/5ml suspension, 100ml bottle

R 9.4500 100ml 24 x 100 ml 21 96 90.00 18-971-2348 BT

69 ISOFLURANE U.S.P., 100ml 1 600 Safeline Pharmaceuticals (Pty) Ltd

VZL63 Isoflurane U.S.P100ml

R 73.2000 1 36 21 144 99.00 18-971-2349 BT

70 ISOFLURANE U.S.P., 250ml 43 600 Safeline Pharmaceuticals (Pty) Ltd

VZL63 Isoflurane U.S.P250ml

R 183.0100 1 36 21 144 99.00 18-019-9767 BT

71 LACTULOSE 3,35g/5ml syrup, 150ml 1 323 600 Pharmacare Limited V2205 Lacson Syrup 150ml R 24.3960 150ml 24 x 150ml 21 24 98.00 18-970-7998 BT72 LACTULOSE 3,35g/5ml syrup, 500ml 29 200 Pharmacare Limited V2205 Lacson Syrup 500ml R 68.1855 500ml 20 x 500ml 21 20 98.00 18-971-1239 BT73 LIQUID PARAFFIN B.P., 200ml 438 600 Pharmachem Laboratories

(Pty) LtdV3LA8 Liquid Paraffin BP R 6.3726 200ml 50 21 100 98.00 18-971-4770 BT

75 LUBRICANT AND CLEANER for surgical instruments, Compatible with stainless steel, titanium, tungsten carbide and aluminium. Neutral pH. Must contain an antimicrobial to prevent growth of micro-organisms at in-use dilutions. Manufacturer to submit ISO 9001 Certificate. Use dilution to be stated. 2,5 - 5 litre , Concentrated

2 300 Sanichem (Pty) Ltd VZRX2 Metrilube R 335.5000 1 4 14 1 x 4 98.00 18-016-2159 CO

78 METHYLATED SPIRITS, clear industrial consisting of 95 parts Ethanol 93,5% V/V and 5 parts denaturants, 20 litre drum

2 500 Resmed Healthcare cc VCEJ2 Resmed Methylated Spirit R 740.5782 25L 1 x 1 x 25L 21 1 x 25L 100.00 18-020-6994 DR

79 METOCLOPRAMIDE HCl 5mg/5ml syrup, 50ml 549 600 Adcock Ingram Healthcare (Pty) Ltd

V2272 Adco-Contromet Alc. & Sugar free 50ml R 4.3900 1 x 50ml 48 21 48 (1 shipper)

98.00 18-971-4323 BT

80 PARACETAMOL 120mg/5ml syrup, Alcohol-, sugar and tartazine free50ml


V4890 Barrs Paracetamol Syrup R 1.9848 50ml 150 21 150 99.00 18-971-2404 BT







85 PHOLCODINE B.P. 15mg/5ml syrup, 100ml 25 200 Resmed Healthcare cc VCEJ2 Resmed Pholcodine Linctus R 27.3600 100ml 1 x 100 x 100ml 21 100 x 100ml 100.00 18-182-8236 BT86 POTASSIUM CITRATE MIXTURE B.P., 200ml 164 000 Barrs Pharmaceuticals (Pty)

LtdV4890 Barrs Pot Cit mixture BP R 10.8200 200ml 70 21 70 99.00 18-970-5099 BT

87 POVIDONE IODINE 100mg/ml antiseptic solution 100ml 21 200 Barrs Pharmaceuticals (Pty) Ltd

V4890 Peviderm R 6.7492 100ml 120 21 120 99.00 18-970-5088 BT


Page 4 of 4




UOM

88 POVIDONE IODINE 100mg/ml antiseptic solution, 1L 501 000 Barrs Pharmaceuticals (Pty) Ltd

V4890 Peviderm R 52.1867 1L 12 21 12 99.00 18-971-2302 BT

91 POVIDONE IODINE 75mg/ml Surgical scrub solution 1litre 66 500 Dismed Pharmaceutical (Pty) Ltd

VBKK5 PVP-I-Scrub 1LCODE 0501300

R 69.5400 1000ml 10 per box 21 10 x 1000ml 93.00 18-971-2111 BT

92 PREDNISOLONE 15mg/5ml syrup, 50ml 149 600 Pharmacare Limited V2205 Aspelone Liquid 50ml R 16.1652 50ml 48 x 6 x 50ml 21 48 98.00 18-018-7762 BT93 PROMETHAZINE HCl 5mg/5ml syrup, 100ml 107 000 Resmed Healthcare cc VCEJ2 Resmed Triomethazine Elixer R 6.8970 100ml 1 x 100 x 100ml 21 100 x 100ml 100.00 18-970-2847 BT94 PROPYLENE GLYCOL B.P., 2,5 litre 1 700 Pharmachem Laboratories

(Pty) LtdV3LA8 Propylene Glycol BP R 148.1088 2,5L 6 21 60 98.00 18-971-4878 CO

95 RISPERIDONE 1mg/ml oral solution, 30ml 97 400 Janssen Pharmaceutica (Pty) Ltd

VBKY6 Risperdal 1 mg/ml R 190.3700 1 x 30ml 30 bottles 21 1 x 30ml 90.00 18-096-8975 BT

96 RUST AND STAIN REMOVER FOR SURGICAL INSTRUMENTS For the removal of water mineral staining, rust and corrosion from stainless steel surgical instruments, trays and basins. Non-corrosive. Certificates to be submitted from manufacturer: 93/42/EEC Medical Device Directive, ISO 9001Certificate of Registration. Concentrated. Use dilution to stated.2,5 - 5 litre

4 800 Sanichem (Pty) Ltd VZRX2 Metrishine R 384.1800 1 4 14 1 x 4 98.00 18-019-9137 CO

98 SEVOFLURANE, 250ml 80 600 Safeline Pharmaceuticals (Pty) Ltd

VZL63 Sevoflurane250ml

R 684.0000 1 x 250ml 1 21 72 98.62 18-019-0323 CO

100 TAR EXTRACTS shampoo, 200ml 199 200 Pharmachem Laboratories (Pty) Ltd

V3LA8 Tar-ex Shampoo R 17.6472 200ml 50 21 100 98.00 18-971-5749 BT

102 VALPROATE SODIUM 200mg/5ml liquid, 300ml 504 100 Sanofi Aventis South Africa (Pty) Ltd

V18F3 Epilim Liquid Sugar-Free R 106.0200 1 bottle of 300ml 24 bottles of 300ml 21 1 shipper pack (24 bottles)

94.00 18-971-3767 BT

104 VITAMIN B COMPLEX syrup Containing per 5ml: VIT B1 2mg, VIT B2 2.5mg, VIT B6 1 mg, VIT B 12 2.5mcg, NICOTINAMIDE10mg100ml

3 772 600 Pharmachem Laboratories (Pty) Ltd

V3LA8 Econosurge Vitamin B Co Syrup R 1.5276 100ml 100 21 500 98.00 18-975-5058 BT

105 VITAMIN, MULTIPLE syrup, containing per 5ml (daily dose): VIT. A 3000 iu, VIT. D 400 iu, VIT B1 1.5mg, VIT B2 1.25mg, VIT B6 1mg, VIT C 50mg, NICOTINAMIDE 10mg 100ml

10 915 400 Pharmachem Laboratories (Pty) Ltd

V3LA8 Econosurge Multivitamin Syrup R 1.5960 100ml 100 21 500 98.00 18-971-8286 BT

106 VITAMINS, MULTIPLE oral drops, containing per 0,6ml: vit. A 3000 - 5000iu, Nicotinamide 10mg, Vit. D 400 iu, Vit. B1 (Thiamine HCl) 1,5mg, Vit. B2 (Riboflavine) 1,2mg, VIT. B6 (Pyridoxine HCl) 0,5 mg and Vit. C 50mg 25ml dropper bottle with calibrated dropper packed as a unit in a cardboard box

425 800 Pharmachem Laboratories (Pty) Ltd

V3LA8 Multivitamin Drops R 7.2846 25ml 100 21 100 98.00 18-970-0483 BT

107 ZINC, ELEMENTAL 10mg / 5ml syrup, 150ml 1 189 400 Pharmachem Laboratories (Pty) Ltd

V3LA8 Econsourge Zinc Syrup R 3.0666 150ml 50 21 300 98.00 18-191-9467 BT

Special Requirements and Conditions of Contract

HP12-2014LQ

SUPPLY AND DELIVERY OF PHARMACEUTICAL LIQUIDS TO THE DEPARTMENT OF HEALTH FOR THE PERIOD 1 OCTOBER 2014 TO

30 SEPTEMBER 2017

VALIDITY PERIOD: 120 days

National Department of Health

Non-compulsory Briefing Session7 July 2014

Time: 10:00 - 11:00

Venue: National Department of Health

242 Struben Street (Cnr Thabo Sehume and Struben streets)Civitas Building, Impilo Boardroom, Pretoria

1

INDEXSPECIAL CONDITIONS OF CONTRACT ........................................................................................ 1

1. BACKGROUND .................................................................................................................... 1

2. EVALUATION CRITERIA .................................................................................................... 1

2.1. PREFERENCE POINTS SYSTEM .................................................................................... 1

3. PRE AWARD SUPPLIER DUE DILIGENCE .................................................................... 2

4. PARTICIPATING AUTHORITIES....................................................................................... 3

4.1. POST AWARD PARTICIPATION ....................................................................................... 3

5. CONTRACT PERIOD .......................................................................................................... 3

6. DOCUMENT SUBMISSION AND COMPLETION ........................................................... 3

6.1. BID DOCUMENTS FOR SUBMISSION ............................................................................ 3

6.2. PRODUCT SPECIFIC DOCUMENTS FOR SUBMISSION ........................................... 4

6.3. COMPLETION OF DOCUMENTS ..................................................................................... 4

7. VALUE ADDED TAX ............................................................................................................ 4

8. TAX CLEARANCE CERTIFICATE ..................................................................................... 4

9. LEGISLATIVE REQUIREMENTS AND AUTHORISATION DECLARATION ............. 5

9.1. LEGISLATIVE REQUIREMENTS ...................................................................................... 5

9.2. DECLARATION OF AUTHORISATION ............................................................................ 5

10. CONTRACT ADMINISTRATION ........................................................................................ 6

11. COUNTER CONDITIONS ................................................................................................... 6

12. PROHIBITION OF RESTRICTIVE PRACTICES ............................................................. 7

13. FRONTING ............................................................................................................................ 7

14. PRODUCT COMPLIANCE .................................................................................................. 8

14.1. SUBMISSION OF SAMPLES ............................................................................................. 8

15. PRODUCT AWARD ............................................................................................................. 9

15.1. AWARD CONDITIONS ........................................................................................................ 9

15.2. SPLIT AND MULTIPLE AWARDS ..................................................................................... 9

16. CLASSES AND GROUPS ................................................................................................. 10

17. PRICE QUALIFICATION AND PRICE REVIEW ........................................................... 11

17.1. PRICE QUALIFICATION ................................................................................................... 11

17.2. PRICE REVIEW .................................................................................................................. 11

17.2.1. Eligibility for price adjustments relating to foreign exchange risk ............................... 11

17.2.2. Method for price adjustments relating to foreign exchange risk ................................. 12

17.2.3. Price Adjustments based on a systematic review of the marketplace ...................... 13

2

18. ORDERS, DELIVERY AND CONTINUITY OF SUPPLY .............................................. 14

18.1. ORDERS .............................................................................................................................. 14

18.2. DELIVERIES........................................................................................................................ 14

18.3. CONTINUITY OF SUPPLY ............................................................................................... 15

19. PACKAGING AND LABELING ......................................................................................... 15

19.1. PACKAGING ....................................................................................................................... 15

19.2. LABELLING ......................................................................................................................... 16

19.3. BARCODES ......................................................................................................................... 16

20. QUALITY .............................................................................................................................. 17

21. SHELF-LIFE ........................................................................................................................ 17

22. POST AWARD .................................................................................................................... 18

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

22.2. MERGERS, TAKE OVERS AND CHANGES IN SUPPLIER DETAILS ..................... 18

22.3. THIRD PARTIES ................................................................................................................. 18

22.4. MONITORING ..................................................................................................................... 18

22.5. REPORTING ....................................................................................................................... 19

23. CONTACT DETAILS .......................................................................................................... 19

24. ABBREVIATIONS ............................................................................................................... 19

3

SPECIAL CONDITIONS OF CONTRACT

1. BACKGROUNDThis 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, the Special Conditions of Contract are in conflict with the

General Conditions of Contract, the Special Conditions of Contract will prevail

2. EVALUATION CRITERIA

2.1. PREFERENCE POINTS SYSTEM2.1.1. In terms of Regulation 6 of the Preferential Procurement Regulations published in

terms of 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 (final delivered price including VAT): maximum 90 points

- B-BBEE status level of bidder: maximum 10 points

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

= 90 1

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

2.1.3. 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:

4

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

2.1.4. Bidders are required to complete the preference claim form (SBD 6.1) in order to

claim the B-BBEE status level points.

2.1.5. The points scored by a bidder in respect of the level of B-BBEE contribution will be

added to the points scored for price

2.1.6. Only bidders who have completed and signed the declaration part of the

preference claim form and who have submitted a B-BBEE status level certificate

issued by a registered auditor, accounting officer (as contemplated in section 60(4)

of Close Corporation Act, 1984 (Act 69 of 1984)) or an accredited verification

agency declaration of the bid documentation will be considered for preference

points.

2.1.7. Failure on the part of the bidder to comply with paragraphs c and e will be deemed

not to have claimed preference points for B-BBEE status level of contribution and

will therefore be allocated zero points.

2.1.8. 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 points.

2.1.9. The points scored will be rounded off to the nearest 2 decimals.

2.1.10. 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 points for B-BBEE. Should

two or more bids be equal in all respects, the award shall be decided by the

drawing of lots.

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

not score the highest number of points.

3. PRE AWARD SUPPLIER DUE DILIGENCEThe Department of Health reserves the right to conduct supplier due diligence prior

to final award.

5

4. PARTICIPATING AUTHORITIESThe National Department of Health and the following Provincial Departments will

participate in this contract: Eastern Cape, Free State, Gauteng, KwaZulu-Natal,

Limpopo, Mpumalanga, Northern Cape, North West and Western Cape

4.1. POST AWARD PARTICIPATIONRegulation 16A6.6 of the Treasury Regulations for Departments, Trading Entities,

Constitutional Entities and Public Entities issued in terms of the Public Finance

Management Act, 1999, (Act 1 of 1999) states that the Accounting

Officer/Accounting Authority may, on behalf of a department, constitutional

institution or public entity, request to participate in any contract arranged by means

of a competitive bidding process by any organ of state, subject to the written

approval of such organ of state and the relevant contractors.

5. CONTRACT PERIODThe contract period shall be for a period of 36 months commencing on 1 October

2014 and ending on 30 September 2017

6. DOCUMENT SUBMISSION AND COMPLETION

6.1. BID DOCUMENTS FOR SUBMISSION6.1.1. Bidders MUST submit the following completed documents with the bid:

SBD1: Invitation to bid

Tax Clearance Certificate refer SBD2: Certificate must be original and valid

SBD4: Declaration of Interest

SBD5: The National Industrial Participation Programme

SBD6.1: Preference points claim form in terms of the Preferential Procurement

Regulations 2011

SBD8:Declaration of bidder's past supply chain management practices

SBD9: Certificate of independent bid determination

B-BBEE Status Level Verification Certificate, original or certified copy

The CIPC document (Reflecting the Entity’s Registration Number and Registered

Name)

PBD1: Authorisation Declaration

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PBD4: Supplier details

PBD5: Declaration of compliance with Good Manufacturing Practice (GMP)

Completed Bid Response Documents (for each item offered)

A certified copy of the license issued by MCC to manufacture, including all

annexures thereto (for products registered with MCC).

6.1.2. Bidders must submit the Bid Response Document on a CD in Excel format

together with signed bid document. Please do not scan or convert to PDF.

6.1.3. Bidders must submit the bid in hard copy format (paper document) before the

closing date and time. The signed hard copy of the bid document will serve as the

legal bid document. The Chief Executive Officer, Chief Financial Officer, or

authorised designee of the entity submitting the bid must sign the bid document

and initial each page with black ink. The use of correction fluid is not acceptable.

Any change/s must be clearly indicated and initialled.

6.1.4. Bid documents must be submitted in a sealed envelope or suitable cover. The full

name and address of the bidder, the bid number and the closing date must be

clearly indicated on the envelope/cover

6.2. PRODUCT SPECIFIC DOCUMENTS FOR SUBMISSIONBidders must submit the following documents for each product offered:

Current MCC approved package insert (copy of package insert included in the

product package, as well as a legible A4 copy of the package insert)

Certified copy of certificate of product registration.

6.3. COMPLETION OF DOCUMENTS6.3.1. Complete all fields in the bid response document for each product offered

6.3.2. Ensure that the pricing component is completed correctly. The bid price offered

must apply to the product specified, e.g. provide price for one bottle or pack, as per

specification.

7. VALUE ADDED TAXAll bid prices must include Value-Added Tax (VAT)

8. TAX CLEARANCE CERTIFICATEAn original and valid Tax Clearance Certificate issued by the South African Revenue

Service must be submitted together with bid documents. Only the original Tax

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Clearance Certificate will be accepted. Contracted Suppliers are obliged to provide

the Department with a valid Tax Clearance Certificate prior to the expiry of the

previously submitted certificate.

9. LEGISLATIVE REQUIREMENTS AND AUTHORISATION DECLARATION

9.1. LEGISLATIVE REQUIREMENTS9.1.1. The bidder offering a product registered with MCC must be the holder of a license

to manufacture or import medicines issued in terms of section 22C(1)(b) of the

Medicines and Related Substances Act, Act 101 of 1965, as amended

9.1.2. The bidder must also be licensed and recorded in terms of Section 22 of the

Pharmacy Act, Act 53 of 1974, as amended

9.1.3. 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. At

submission of bid, and for the duration of the contract, the medicines must comply

with conditions of registration

9.1.4. 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

9.1.5. Non-compliance with the above mentioned legal requirements will invalidate the

bid for such products offered

9.2. DECLARATION OF AUTHORISATION9.2.1. In the case of a product requiring registration in terms of the Medicines and

Related Substances Act, Act 101 of 1965, only the holder of a certificate of

registration for such product, may submit a bid.

9.2.2. In the event of the bidder being an importer, or making use of a contract

manufacturer, the bidder must ensure that all legal, financial and supply

arrangements have been mutually agreed upon between the bidder and the

importer/contract manufacturer.

9.2.3. No agreement between the bidder and a third party will be binding on the

Department of Health.

9.2.4. Failure to submit a duly completed and signed Authorisation Declaration, where

applicable, may invalidate the bid for such goods offered.

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9.2.5. The Department reserves the right to at any time 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 not to consider the bid or cancel the contract, if

already awarded.

9.2.6. Accountability with regard to meeting the conditions of this contract rests with the

bidder.

10. CONTRACT ADMINISTRATION 10.1 The administration of the contract is the responsibility of the National Department of

Health. All correspondence in this regard must be directed to the Director: Affordable

Medicines

10.2 The National Department of Health will communicate with bidders to request

extension of the validity period of the bid, should it be necessary.

10.3 All communication between the bidder and the Department of Health must be in

writing.

10.4 Any communication to any government official or a person acting in an advisory

capacity for the Department of Health in respect of this bid between the closing date

and the award of the bid by the bidder is discouraged.

10.5 Contracted suppliers must advise the Director: Affordable Medicines within seven

days of receiving an order when unforeseeable circumstances occur that may

adversely affect supply against the contract. Full particulars of such circumstances

must be provided by the supplier.

10.6 The National Department of Health will monitor supplier performance and will

request provincial departments to impose penalties if deemed necessary

10.7 Non-performance of contracted suppliers in terms of this contract may influence

participation in future Department of Health contracts

11. COUNTER CONDITIONSAny amendments to any of the bid conditions, changes to bid specifications or

setting of any other counter conditions by bidders may result in the invalidation of

such bids.

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12. PROHIBITION OF RESTRICTIVE PRACTICES12.1 In terms of section 4 (1) of the Competition Act, Act 89 of 1998, as amended, an

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

of firms, is prohibited if it is between parties in a horizontal relationship and if a

bidder(s) is / are or a contractor(s) was / were involved in:

directly or indirectly fixing a purchase or selling price or any other trading

condition;

dividing markets by allocating customers, suppliers, territories or specific types

of goods or services; or

collusive bidding.

12.2 Section 4(2) of Act 89 of 1998 states that an agreement to engage in a restrictive

horizontal practice referred to in subsection (1)(b) of the Act is presumed to exist

between two or more firms if:

any one of those firms owns a significant interest in the other, or they have at

least one director or substantial shareholder in common; or

any combination of those firms engages in that restrictive horizontal practice.

12.3 If a bidder(s) or contracted supplier(s), in the judgment of the purchaser, has/have

engaged in any of the restrictive practices referred to above, the purchaser may

refer the matter to the Competition Commission for investigation and possible

imposition of administrative penalties as contemplated in the Competition Act 89 of

1998.

12.4 If a bidder(s) or contracted supplier(s) has/have been found guilty by the

Competition Commission of any of the restrictive practices referred to above, the

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

invalidate the bid(s) for such item(s) offered, and/or terminate the contract in whole

or part, and/or restrict the bidder(s) or contracted supplier(s) from conducting

business with the public sector for a period not exceeding ten (10) years and/or

claim damages from the bidder(s) or contracted supplier(s) concerned.

13. FRONTING13.1 The Department of Health supports the spirit of broad-based black economic

empowerment and recognises that real empowerment can only be achieved through

individuals and businesses conducting themselves in accordance with the

Constitution and in an honest, fair, equitable, transparent and legally compliant

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manner. Against this background the Department of Health condemns any form of

fronting.

13.2 The 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 Treasury may have against the

bidder/contractor concerned.

14. PRODUCT COMPLIANCEPrior to award products will be evaluated for:

Compliance with specifications as set out in the Bid Response Document

Product registration with Medicines Control Council (MCC)

Availability of sample and physical compliance with specification

14.1. SUBMISSION OF SAMPLES14.1.1. No samples must be sent to the Directorate: Affordable Medicines

14.1.2. Samples must be marked with the bid number, the item number as well as the

bidder’s name and address

14.1.3. Bidders must submit at least one original pack of each offer for physical evaluation

14.1.4. Bids where samples are not submitted, will not be considered for award

14.1.5. Samples must be submitted to each of the addresses indicated below, prior to

closing date and time of bid:

Mr Dumisani Malele Mr Nisaar Mia

Depot Manager Pharmaceutical Policy Specialist

Tel: 011 628 9001 Tel: 021 483 5800

Gauteng Medical Supplies Depot Western Cape: Department of Health

Store 3 Pharmaceutical Services

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35 Plunkett Avenue 4 Dorp Street, Room 10-07

Hurst Hill Cape Town

2092 8001

14.1.6. It is the responsibility of the bidder to ensure that samples have been received at

the addresses provided

14.1.7. All samples for awarded items will be retained for the period of the contract

14.1.8. All samples must be a true representation of the product which will be supplied

14.1.9. All samples submitted must be inclusive of the MCC approved package insert

14.1.10. No samples will be required for schedule 6 items

15. PRODUCT AWARD

15.1. AWARD CONDITIONS15.1.1. The Department of Health reserves the right not to award a line item.

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

15.1.3. In cases where the tender does not achieve the most economically advantageous

price, the Department of Health may not award that item.

15.1.4. The Department of Health requires pack sizes suitable for a 28 day treatment

cycle. Should a 30-day pack size be offered, no conversion factor will be applied.

Direct comparisons will be made between 28 and 30 day pack sizes.

15.1.5. The Department of Health reserves the right to change treatment protocols and/or

product formulations where required due to emerging clinical evidence, disease

profiles, safety or resistance patterns.

15.2. SPLIT AND MULTIPLE AWARDS15.2.1. The Department of Health reserves the right to issue split or multiple awards,

where necessary, to ensure security of supply

15.2.2. The following will be taken into consideration when contemplating a split award

Source of API and manufacturing site

Capacity to meet volume demand as per Bid Response Document

Estimated volume to be supplied; or

Risk to public health if the item is not available.

15.2.3. Two-way split awards will be made in accordance with the following schedule

based on the points scored:

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15.2.4 The Department of Health reserves the right to issue multiple (more than two-way) awards. Award will be done according to the weighted proportion of points scored.

16. CLASSES AND GROUPS16.1 To achieve the most economically advantageous contract in the case of specific

items, the Department of Health invites bids based on the classes and/or group(s)

as listed in section 16.5 below.

16.2 A single item will be awarded in a group. In some cases more than one item may be

awarded.

16.3 Where regimens require dose titrations a series award within a class may be

necessary. In this context, a series award means that the same item is awarded in

different groups of a class. The following approach will be applied to select items to

establish the series:

The group with the highest volume within a class will be identified;

The item with the highest points within that group will be selected;

For the remainder of the groups in that class, the same generic product will be

selected to complete the series, provided that price per unit (e.g. mg) is

acceptable;

16.4 The Department of Health reserves the right to award split awards across a class

16.5 Classes with groups are listed below:

Class 1 Group 1

Item 17 Cetirizine dihydrochloride 5mg/5ml syrup, 150ml bottle

Item 39 Desloratadine 2.5mg/5ml syrup, 150ml bottle

Item 74 Loratadine 5mg/5ml syrup, 150ml bottle

Category Difference between

points scored

Recommended

percentage split

A Equal points 50/50

B < 5 points 60/40

C >5-10 points 70/30

D >10-20 points 80/20

E >20 points 90/10

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Class 2Group 1

Item 52 Ferrous gluconate 350mg / 5ml equivalent to elemental iron 40mg/5ml syrup, 100ml bottle

Item 68 Iron polymaltose 5ml equivalent to elemental iron 50mg/5ml syrup, 100ml bottle

Class 3Group 1

Item 102 Valproate sodium 200mg/5ml liquid, 300ml bottle sugar free

Item 103 Valproate sodium 250mg/5ml liquid, 100ml bottle sugar free

17. PRICE QUALIFICATION AND PRICE REVIEW

17.1. PRICE QUALIFICATION 17.1.1. Prices submitted for this bid will be regarded as firm and subject only to review in

terms of paragraph 17.2

17.1.2. Bidders must quote a final delivered price inclusive of Value Added Tax (VAT)

17.1.3. Price must be specific for the units advertised per item specification

17.2. PRICE REVIEWThe Department of Health envisages two types of price review processes for the

duration of this contract:

An adjustment to mitigate foreign exchange fluctuations in excess of those

catered for by usual business practices;

A systematic review of prices for comparable products available in the

international marketplace.

17.2.1. Eligibility for price adjustments relating to foreign exchange risk17.2.1.1. Eligibility for price adjustments relating to foreign exchange risk depends on

submission of a complete price breakdown as per instructions below

assessment of rationality of price breakdown by Department of Health

17.2.1.2. The price breakdown must be completed on the signed bid response document.

The delivered price must be divided across five components:

1. Active Pharmaceutical Ingredients (API);2. Formulation;3. Packaging;

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4. Local transport;5. Profit margin (remaining portion).

17.2.1.3. The sum of these categories must be equal to 100% of the delivered price for

the line item

17.2.1.4. The local + imported portions of the first three components must add up to

100% within each component (e.g. Portion of API attributable to local + Portion

of API attributable to import = 100% of specific API component

17.2.1.5. See extract from bid response document below:

Price components Response fields

Foreign Currency Foreign currency associated with import

Price Breakdown by components relating to

eligibility for Foreign Exchange Price Adjustments

(Paragraph 16.2 SCC): The 5 components should

add up to 100% of the delivered price. If complete product is imported, ignore

API and only list under formulation component. If

packaging is included under formulation list only under

formulation.

1) API % Component 1

Local % Portion of Component 1 attributable to local

Imported % Portion of Component 1 attributable to import

2) Formulation % Component 2


Imported % Portion of Component 2 attributable to import

3) Packaging % Component 3


Imported % Portion of Component 3attributable to import

4) Transportation % Component 4 5) Profit Margin % Component 5

17.2.1.6. VAT must be apportioned equally across all components and not regarded as a

separate component

17.2.1.7. Breakdown must be in percentage format to a maximum of four decimal places

(e.g. 20.5555%) All decimals must be visible in the signed bid submission.

17.2.2. Method for price adjustments relating to foreign exchange risk17.2.2.1. Only the portion of the bid price facing foreign exchange risk will be adjusted.

This portion is determined by the price breakdown on the signed bid submission

17.2.2.2. Adjustments are always calculated using the original awarded contract price as

the base

17.2.2.3. Price adjustments relating to foreign exchange will be based on the percentage

change between a base average rate of exchange (RoE) and an adjustment

average RoE. Rates are sourced from the Reserve Bank (www.resbank.co.za).

17.2.2.4. Base average RoE for this tender will be as follows, per currency:

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Currency Base Average Rates of Exchange1 Dec 2013 to 31 May 2014

US Dollar R 10.6608

Br Pound R 17.6987

Euro R 14.6282

17.2.2.5. Should the bidder make use of any currency not mentioned above, the bidder

must stipulate this clearly and submit the calculated average RoE for the period

1 December 2013 to 31 May 2014 using the South African Reserve Bank

published rates for the specific currency.

17.2.2.6. Schedule for price reviews, and periods for calculating adjustment average

RoE, are detailed in the table below:

Review Period for calculating adjustment RoE

Submission of request for price review to reach the office by

Date from which adjusted prices will become effective

1 1 June 2014 - 28 February 2015

7 March 2015 1 April 2015

2 1 March 2015 - 31 August 2015

7 September 2015 1 October 2015

3 1September 2015 - 29February 2016


4 1 March 2016 - 31 August 2016

7 September 2016 1 October 2016

5 1September 2016 - 28February 2017


17.2.2.7. Signed applications for price adjustments must be received by the National

Department of Health prior to the submission dates detailed in the table above.

Where no application for an adjustment relating to foreign exchange has been

received and such an adjustment would be favourable to the Department, this

will be implemented automatically

17.2.2.8. Foreign exchange adjustments may not result in a price exceeding the current

Single Exit Price

17.2.3. Price Adjustments based on a systematic review of the marketplace17.2.3.1. The National Department of Health reserves the right to:

Perform a market review of the international pharmaceutical industry;

Should the review identify that contract prices are unfavourable; the

Department of Health will contact and enter into price negotiations with the

contracted supplier.

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18. ORDERS, DELIVERY AND CONTINUITY OF SUPPLY

18.1. ORDERS18.1.1. The quantities reflected in the bid documents are estimated volumes and are not

guaranteed.

18.1.2. Fluctuations in monthly off-take may occur.

18.1.3. The Department of Health is under no obligation to purchase stock of any item

which is in excess of the estimated quantities in the contract.

18.1.4. Proposed minimum order quantities should facilitate delivery directly to facilities.

Where consensus regarding minimum order quantities cannot be reached the bid

may not be awarded.

18.1.5. Contracted suppliers may be requested to pack orders to facilitate cross-docking

18.1.6. Changes to the quantity ordered may only be done upon receipt of an amended

order.

18.1.7. The Department of Health reserves the right to purchase its requirements outside

of the contract if:

the contracted supplier fails to perform in terms of the contract;

the item(s) are urgently required and not immediately available;

In the case of an emergency.

18.1.8. The Department of Health reserves the right to cancel orders where the lead time

exceeds the delivery lead time specified in the contract.

18.1.9. In cases where an order which appears to be atypical is received, the contracted

supplier must inform the Department of Health.

18.2. DELIVERIES18.2.1. Products must be delivered in accordance with contracted conditions and

instructions given by Participating Authorities and institutions placing the orders.

18.2.2. Lead time is defined as the time from placement of order to delivery. The lead time

may not exceed 3 weeks (21 calendar days). Failure to comply with the contractual

lead time will lead to imposition of penalties.

18.2.3. The initial lead time as proposed in the bid response document will be calculated

from date of award of the contract and NOT the date of placement of the first order.

This period may not exceed 60 calendar days from the date of award

18.2.4. The delivery note must reference the order number, delivery address and any

instructions for delivery

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18.2.5. Invoices must be submitted in accordance with instructions given by Participating

Authorities and institutions placing orders. This invoice must include the national

stock number of the product and description as it appears on the contract.

18.2.6. Original invoices and proof of delivery signed by a delegated official at the

institution should be delivered / posted to the authority responsible for payment

18.2.7. Deliveries must be in accordance with orders placed. Contracted suppliers will be

responsible for upliftment of goods delivered erroneously.

18.2.8. Discrepancies must be reported to the contracted supplier within two working days

of receipt of delivery

18.2.9. During delivery environmental conditions must be maintained in accordance with

conditions of registration of the product

18.3. CONTINUITY OF SUPPLYContracted suppliers must:

maintain regular supply throughout the duration of the contract;

disclose future plans which may impact on the ability to meet the estimated

demand;

inform the National Department of Health of any regulatory action which may

impact on their GMP status or those of regulated entities that they are reliant on;

inform the National Department of Health of any anticipated problems associated

with the availability of Active Pharmaceutical Ingredient (API).

19. PACKAGING AND LABELING

19.1. PACKAGING19.1.1. Suppliers must ensure that supplies delivered are received in good order at the

point of delivery. Packaging must be suitable for further dispatch, storage and

stacking according to Good Wholesaling Practice and Good Distribution Practice.

19.1.2. The packing must be uniform for the duration of the contract period. All products

must be packed in acceptable containers, specifically developed for the product.

19.1.3. The number of units in the unit pack, shelf pack and shipper pack must be

completed in the Bid Response Document.

19.1.4. Where a particular stacking and storage configuration is recommended by the

supplier, this should be clearly illustrated on the outer packaging.

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19.1.5. Where the contents of the shipper represents a standard supply quantity of an item,

the following must be adhered to:

Outer packaging flanges must be sealed with suitable tape that will clearly display evidence of tampering The contents must be packed in neat, uniform rows and columns that will facilitate easy counting when opened.

19.1.6. Where the contents a shipper represents a non-standard supply quantity, the

following must be adhered to:

Outer packaging flanges must be sealed with suitable tape that will clearly display evidence of tampering. The outer packaging must be clearly marked as a "Part Box" or "Mixed Content".

19.2. LABELLING19.2.1. All containers, packing and cartons must be clearly labelled. Bulk packs must be

labelled in letters not less than font size 48.

The following information must be clearly and indelibly printed on all shelf and

shipper packs.

Generic name and strength

Proprietary name

Number of units in pack (e.g. for bulk packs 80 x 10 x 100s)

Batch Number

Expiry date

Storage conditions

Barcode

19.2.2. Where the contents of the shipper requires special attention in terms of storage or

handling, e.g. thermo labile, high-scheduled or cytotoxic products, such

instructions must be clearly and visibly indicated on the outer packaging on a

brightly coloured background

19.2.3. Unit packs must be labelled in accordance with Regulation 8 of the General

Regulations published in terms of the Medicines and Related Substances Act, Act

101 of 1965. The label must include a barcode.

19.3. BARCODES19.3.1. It is mandatory that all products supplied must include a barcode (number plus

symbology). All shipper, shelf and unit packs must be marked with the appropriate

number and symbology. The European Article Numbering Code 13 (EAN 13) has

been accepted as standard.

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19.3.2. 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.

19.3.3. Barcodes must include the following information:

The generic name of the product

Brand name

Dosage form and strength

Pack size

Batch number

Expiry date

20. QUALITYProducts must conform with the conditions of registration of the product with

Medicines Control Council or relevant quality standards, where applicable.

21. SHELF-LIFE21.1 Unless the stability of a product has required the MCC to approve a shorter shelf

life, products must have a shelf-life of at least 18 months upon delivery.

21.2 Contracted suppliers may apply in writing to Participating Authorities to supply a

product with a shorter shelf life provided that:

applications are accompanied by an undertaking that such short-dated products

will be unconditionally replaced or credited before or after expiry AND

applications are approved before execution of orders AND

such products must be collected by the supplier at their own cost AND

failure to collect the products within 30 days after written notification to the

supplier will result in the disposal of the product by the Participating Authority for

the account of the supplier.

21.3 If short-dated products are delivered without the aforementioned undertaking the

following discount formula will be applied for invoicing of short-dated products:

A=2 x (18 – months to date of expiry) % x consignment value short dated

product. Therefore, amount to be invoiced is: Consignment value minus A,

where A is the value of the outcome of the discount formula.

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21.4 Any Participating Authority may, without prejudice, decline to accept product with a

shelf-life of less than 18 months.

22. POST AWARD

22.1. REGISTRATION ON DATABASES OF PARTICIPATING AUTHORITIES22.1.1. All contracted suppliers must register on the supplier databases of Participating

Authorities within 30 days after award of contract

22.1.2. Failure to meet this requirement may result in bidders being excluded for future

contracts

22.2. MERGERS, TAKE OVERS AND CHANGES IN SUPPLIER DETAILS22.2.1. Where a contracted supplier merges with or is taken over by another, the

contracted supplier must inform the Department of Health in writing 30 days prior

to such event of relevant details

22.2.2. The Department of Health reserves the right to agree to the transfer of contractual

obligations to the new supplier under the prevailing conditions of contract or to

cancel the contract

22.2.3. A contracted supplier must inform the National Department of Health within 14

days of any changes of address, name, contact or banking details.

22.3. THIRD PARTIES22.3.1. Participating authorities will not make a payment to or consult with a third party

22.3.2. No third party is entitled to put an account of a Participating Authority on hold

22.4. MONITORING22.4.1. Any change in the GMP status during the contract period must be reported within

seven days of receipt of such notice from the Medicines Control Council to the

Department

22.4.2. The Department of Health will monitor the performance of contracted suppliers and

maintain a scorecard for compliance to the terms of this contract as follows:

Compliance to delivery lead times

Percentage of orders supplied in full first time. (Suppliers will not be penalized in

this regard if they have been requested in times of shortages to supply part

orders according to need)

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Compliance with reporting requirements according to reporting schedule

22.5. REPORTINGSuppliers must report monthly by the 7th day of the following month to the

National Department of Health providing detail of orders received and products

supplied in terms of this contract. The Department will provide contracted suppliers

with the required format and content requirements of such reports. Reports should

be submitted to the following e-mail address: [email protected].

23. CONTACT DETAILSDirectorate: Affordable Medicines, Private Bag X828, Pretoria, 0001

or physical address:

242 Struben Street Cnr Thabo Sehume Street, Civitas Building, Pretoria, 0001.

Please use the following e-mail address to communicate with the Department:

[email protected].

Contact persons for enquiries:

Ms M Rasengane Ms P Moloko

Tel: (012) 395 9452 Tel: (012) 395 8439

Fax number: (012) 395 8823

24. ABBREVIATIONSThe abbreviations used in this document signify the following:

BEC Bid Evaluation Committee

B-BBEE Broad-Based Black Economic Empowerment

GMP Good Manufacturing Practice

MCC Medicines Control Council

NDoH National Department of Health

API Active Pharmaceutical Ingredient

VAT Value Added Tax

RoE Rate of Exchange

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