hp04-2014onc contract circular period: 1 april 2014 to 31 march 2016 page 1 of 8 no. description

HP04-2014ONC Contract Circular Period: 1 April 2014 to 31 March 2016

Page 1 of 8

No. Description Quantity Awarded

Name of Supplier Supplier Code

Brand name Delivered Price Unit Pack Shipper Pack

Lead Time(Days)

Minimum Order

Quantity

Total Points

National Stock Number

Unit of Measure

1 ANASTRAZOLE 1mg tablet, 30 tablets 50,215 Astrazeneca Pharmaceuticals (Pty) Ltd

V2180 Arimidex 1mg 30's

R 48.84 1 18 14 1 92.00 18-022-1034 CO

3 ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT) 20mg/ml injection, 5ml vial For IV infusion

610 Fresenius Medical Care South Africa (Pty) Ltd

V02Y6 ATG Fresenius S R 3,670.80 1 x 5ml vial 10 vials per shipper

3 5 vials 90.00 18-032-7500 VI

4 AZATHIOPRINE 50mg tablet, 100 tablets

71,078 Litha Pharma (Pty) Ltd VGS73 Azamun R 90.00 1 x 50mg Tablets 100's

72 21 5 94.00 18-971-0268 CO

5 BICALUTAMIDE 50mg tablet, 30 tablets 11,639 Accord Healthcare (Pty) Ltd V2MB8 Caloxa R 75.01 1 200 21 10 90.00 18-032-2990 CO

6 BLEOMYCIN 15 iu injection, ampoule/vial

23,458 Pharmachemie (Pty) Ltd VWD89 Bleolem R 220.10 1 80 21 1 91.00 18-177-0198 VI

9 CALCIUM FOLINATE equivalent to FOLINIC ACID 15mg tablet, 10 tablets

4,715 Pharmachemie (Pty) Ltd VWD89 Rescuvolin Tablets

R 146.89 10 352 21 1 91.00 18-971-1671 CO

10 CALCIUM FOLINATE equivalent to FOLINIC ACID 200mg/20ml injection, vial

7,359 Pharmachemie (Pty) Ltd VWD89 Abic Leucovorin 200mg

R 99.00 1 189 21 1 91.00 18-185-8212 VI

11 CALCIUM FOLINATE equivalent to FOLINIC ACID 300mg/30ml injection, vial

692 Pharmachemie (Pty) Ltd VWD89 Abic Leucovorin 300mg

R 148.50 1 126 21 1 91.00 18-184-8888 VI

12 CALCIUM FOLINATE equivalent to FOLINIC ACID 50mg injection, vial

42,648 Pharmachemie (Pty) Ltd VWD89 Rescuvolin PFI 50 R 24.75 1 189 21 1 91.00 18-096-9777 VI

13 CAPECITABINE 150mg tablet, 60 5,387 Roche Products (Pty) Ltd V2177 Xeloda 150 R 330.83 60 168 21 1 93.00 18-095-7667 CO

14 CAPECITABINE 500mg tablet, 120 6,631 Roche Products (Pty) Ltd V2177 Xeloda 500 R 2,225.94 120 65 21 1 93.00 18-095-8744 CO

15 CARBOPLATIN 150mg injection, for IV infusion

3,346 Pharmachemie (Pty) Ltd VWD89 Carbosin 150 R 151.28 1 1 21 1 91.00 18-971-4187 VI

16 CARBOPLATIN 450mg injection, for IV infusion

12,549 Pharmachemie (Pty) Ltd VWD89 Carbosin 450 R 396.76 1 70 21 1 91.00 18-174-4809 VI

Bid Number: HP04-2014ONCBid Description: Supply and Delivery of Oncology and Immunological Agents to the Department of Health for the period from 01 April 2014 to 31 March 2016


Page 2 of 8




Lead Time(Days)

Minimum Order

Quantity

Total Points


Unit of Measure


17 CHLORAMBUCIL 2mg tablet, 25 tablets 2,846 Pharmacare Ltd V2205 Leukeran 2mg Tablets 25's

R 298.23 25 Tablets 18 x 10 x 25 Tablets

21 4 98.00 18-971-0834 CO

18 CICLOSPORIN 25mg capsule, 50 capsules

21,688 Novartis South Africa (Pty) Ltd VBVW2 Sandimmun Neoral 25mg capsule

R 188.67 1 60 21 1 93.00 18-000-1218 CO

19 CICLOSPORIN 100mg capsule, 50 capsules

11,164 Novartis South Africa (Pty) Ltd VBVW2 Sandimmun Neoral 100mg capsule

R 754.11 1 50 21 1 93.00 18-000-1233 CO

20 CICLOSPORIN 100mg/ml Oral solution, 50ml

463 Novartis South Africa (Pty) Ltd VBVW2 Sandimmun Neoral 100mg/ml oral solution

R 1,027.85 1 42 21 1 93.00 18-971-2364 VI

21 CICLOSPORIN 50mg injection, 1ml ampoule

16,385 Novartis South Africa (Pty) Ltd VBVW2 Sandimmun Ampoules 50mg/ml Injection

R 26.40 1 120 21 10 93.00 18-007-3825 AM

23 CISPLATIN 50mg injection, for IV infusion

43,564 Accord Healthcare (Pty) Ltd V2MB8 Cisacor 50 R 59.05 1 60 21 12 90.00 18-034-8860 VI

24 CYCLOPHOSPHAMIDE 1g powder for injection, vial

53,210 Sanofi-Aventis South Africa (Pty) Ltd

V2160 Endoxan Injection 1g

R 113.98 1 Pack with one Vial

80 21 1 94.00 18-970-4487 VI

25 CYCLOPHOSPHAMIDE 500mg powder for injection, vial


V2160 Endoxan Injection 500mg

R 77.71 1 Pack with one Vial

240 21 1 94.00 18-971-4915 VI

26 CYCLOPHOSPHAMIDE 50mg tablet, 50 tablets


V2160 Endoxan 50mg Tablets

R 189.62 1 x 50 Tablets 80 21 1 94.00 18-971-4585 CO

27 CYTARABINE 100mg injection, ampoule/vial

9,988 Pharmachemie (Pty) Ltd VWD89 Laracit 100mg R 23.77 1 468 21 1 91.00 18-016-6911 VI

28 CYTARABINE 500mg injection, ampoule/vial

46,254 Pharmachemie (Pty) Ltd VWD89 Laracit 500mg R 57.18 1 384 21 1 91.00 18-016-6912 VI

29 DAUNORUBICIN HCl 20mg powder for injection, vialFor IV infusion

11,014 Pfizer Laboratories (Pty) Ltd V2189 Daunoblastin 20mg PDR for Injection

R 61.51 1 180 21 1 92.00 18-971-1112 VI


Page 3 of 8




Lead Time(Days)

Minimum Order

Quantity

Total Points


Unit of Measure


30 DOCETAXEL 20mg injection, for IV infusionItems 30 & 31 may be considered as a series

6,991 Cipla Medpro South Africa Ltd VXZ32 Cipla Docetaxel 20 with solvent

R 261.26 1 288 21 5 85.39 18-018-2958 VI

31 DOCETAXEL 80mg injection, for IV infusionItems 30 & 31 may be considered as a series

23,325 Cipla Medpro South Africa Ltd VXZ32 Cipla Docetaxel 80 with solvent

R 825.78 1 180 21 5 92.79 18-018-2961 VI

32 DOXORUBICIN (ADRIAMYCIN) HCl 10mg injection, for IV infusion

7,021 Cipla Medpro South Africa Ltd VXZ32 Cipla-Doxorubicin 10

R 19.97 1 1 21 1 95.88 18-976-2107 VI

33 DOXORUBICIN HCl (ADRIAMYCIN) 50mg injection, for IV infusion

53,452 Pharmachemie (Pty) Ltd VWD89 Doxorubicin RTU 50mg

R 66.89 1 70 21 1 91.00 18-976-2108 VI

34 EPIRUBICIN HCl 10mg injection, for IV infusion

3,662 Pharmachemie (Pty) Ltd VWD89 Epirubicin-Lemery 10mg

R 39.81 1 414 21 1 91.00 18-971-0736 VI

35 EPIRUBICIN HCl 50mg injection, for IV infusion

41,419 Pharmachemie (Pty) Ltd VWD89 Epirubicin-Lemery 50mg

R 133.36 1 1 21 1 91.00 18-971-0735 VI

36 ETOPOSIDE 20mg/ml injection, 5ml vial 51,514 Pharmachemie (Pty) Ltd VWD89 Eposin R 48.41 1 210 21 1 91.00 18-007-6160 VI

37 Everolimus, 0.25 mg tablet, 60 tablets 29 Novartis South Africa (Pty) Ltd VBVW2 Certican 0.25mg Tablets

R 604.20 1 64 21 1 93.00 18-180-7552 CO

38 Everolimus, 0.75 mg tablet, 60 tablets 45 Novartis South Africa (Pty) Ltd VBVW2 Certican 0.75mg Tablets

R 1,812.60 1 90 21 1 93.00 18-181-0492 CO

39 Exemestane, 25 mg tablet, 30 tablets 1,702 Pfizer Laboratories (Pty) Ltd V2189 Aromasin 25mg Tablets

R 339.25 1 240 21 1 92.00 18-178-5231 CO

40 FILGRASTIM 30MU injection 68,251 Roche Products (Pty) Ltd V2177 Neupogen 30 MU R 431.70 5 36 21 5 93.00 18-014-1740 VI

41 FILGRASTIM 48MU/0.5ml injection, 0.5ml prefilled syringe

3,556 Roche Products (Pty) Ltd V2177 Neupogen 48 MU R 667.33 5 36 21 5 93.00 18-095-4695 SG


Page 4 of 8




Lead Time(Days)

Minimum Order

Quantity

Total Points


Unit of Measure


42 FLUDARABINE 50 mg for injection 2,388 Pharmachemie (Pty) Ltd VWD89 Teva Fludarabine Phosphate

R 555.75 1 210 21 1 91.00 18-022-1925 VI

43 FLUDARABINE PHOSPHATE 10mg tablets, 20

362 Sanofi-Aventis South Africa (Pty) Ltd

V2160 Fludara Oral R 5,791.82 1 Pack of 20 Tablets

100 21 1 94.00 18-184-0965 CO

45 5-FLUOROURACIL 50mg/ml injection, 10ml ampoule/vial

123,134 Pharmachemie (Pty) Ltd VWD89 Fluracedyl 500mg R 30.01 1 210 21 1 91.00 18-096-9517 VI

48 GEMCITABINE 1g for IV infusion 11,535 Accord Healthcare (Pty) Ltd V2MB8 Cytigem 1g R 269.72 1 60 21 10 90.00 18-018-8832 VI

49 GEMCITABINE 200mg for IV infusion 5,465 Accord Healthcare (Pty) Ltd V2MB8 Cytigem 200mg R 67.03 1 400 21 10 90.00 18-018-8801 VI

50 GOSERELIN 10.8 mg injection 23,890 Astrazeneca Pharmaceuticals (Pty) Ltd

V2180 Zoladex 10,8mg R 723.62 1 1 14 1 92.00 18-096-9540 SG

51 GOSERELIN 3,6 mg injection 7,125 Astrazeneca Pharmaceuticals (Pty) Ltd

V2180 Zoladex 3,6mg R 416.74 1 1 14 1 92.00 18-970-9944 SG

52 GRANISETRON 1mg tablet, 10 tablets 20,561 Roche Products (Pty) Ltd V2177 Kytril 1mg Oral R 16.79 10 590 21 1 93.00 18-177-4389 CO

56 IDARUBICIN HCl 10 mg for injection, for IV infusion

202 Pfizer Laboratories (Pty) Ltd V2189 Zavedos 10mg Powder for Injection

R 881.41 1 180 21 1 92.00 18-011-9309 VI

57 IFOSFAMIDE 1000mg for injection 5,372 Sanofi-Aventis South Africa (Pty) Ltd

V2160 Holoxan 1g Injection

R 442.41 1 Pack of 1 Vial 80 21 1 94.00 18-971-4258 VI

58 IFOSFAMIDE 2000 mg for injection 10,997 Sanofi-Aventis South Africa (Pty) Ltd

V2160 Holoxan 2g Injection

R 750.52 1 Pack of 1 Vial 80 21 1 94.00 18-971-4259 VI

59 IFOSFAMIDE 500 mg for injection 224 Sanofi-Aventis South Africa (Pty) Ltd

V2160 Holoxan 500mg Injection

R 265.45 1 Pack of 1 Vial 120 21 1 94.00 18-971-4257 VI

60 IMATINIB MESILATE 100 mg tablets, 60 tablets

1,750 Cipla Medpro South Africa Ltd VXZ32 Imavec R 404.82 1 1 21 1 99.00 18-175-8086 CO


Page 5 of 8




Lead Time(Days)

Minimum Order

Quantity

Total Points


Unit of Measure


62 INTERFERON ALFA-2a 3 000 000 iu injection, 0.5ml prefilled syringe

11,034 Roche Products (Pty) Ltd V2177 Roferon-A 3MIU/0.5ml

R 122.37 1 96 21 1 93.00 18-034-8815 SG

63 INTERFERON ALFA-2a 4 500 000 iu injection, 0.5ml prefilled syringe

1,847 Roche Products (Pty) Ltd V2177 Roferon-A 4.5 MIU/0.5ml

R 183.56 1 96 21 1 93.00 18-034-8818 SG

65 INTERFERON ALFA-2a 9 000 000 iu injection, 0,5ml prefilled syringe

2,649 Roche Products (Pty) Ltd V2177 Roferon-A 9MIU/0.5ml

R 367.12 1 96 21 1 93.00 18-034-8820 SG

66 INTERFERON ALFA-2b 10 000 000 iu dose/6 dose injection pen

278 MSD (Pty) Ltd V2185 Intron A Redipen R 2,827.44 1 x 1.2ml 1 21 1 92.00 18-096-9587 SE

68 INTERFERON ALFA-2b 5 000 000 iu dose/6 dose injection pen

1,103 MSD (Pty) Ltd V2185 Intron A Redipen R 1,413.72 1 x 1.2ml 1 21 1 92.00 18-096-9586 SE

71 MEDROXYPROGESTERONE ACETATE 100mg tablet, 100 tablets

522 Pfizer Laboratories (Pty) Ltd V2189 Provera 100mg Tablets

R 506.51 100 24 21 1 92.00 18-971-1677 CO

72 MEDROXYPROGESTERONE ACETATE 500mg tablet, 100 tablets

348 Pfizer Laboratories (Pty) Ltd V2189 Provera 500mg Tablets

R 1,721.69 100 24 21 1 92.00 18-971-5371 CO

73 MELPHALAN 2mg tablet, 25 tablets 3,561 Pharmacare Ltd V2205 Alkeran 2mg Tablets 25's


21 3 98.00 18-971-2268 CO

74 MELPHALAN 50mg injection, vial + diluent

1,026 Pharmacare Ltd V2205 Alkeran 50mg Injection

R 453.78 1 Vial & Diluent 72 x 1 Vial & Diluent

21 3 98.00 18-018-5781 VI

75 MERCAPTOPURINE 50mg tablet, 25 tablets

10,711 Pharmacare Ltd V2205 Puri-Nethol 50mg Tablets 25's


21 2 98.00 18-971-0669 CO

76 MESNA 400mg injection, ampoule 102,826 Sanofi-Aventis South Africa (Pty) Ltd

V2160 Uromitexan 400mg Injection

R 37.13 1 Pack of 15 ampoules

20 Packs 21 1 Pack of 15 ampoules

94.00 18-971-1688 AM

77 METHOTREXATE 1g injection, vialFor IV infusion

8,344 Pharmachemie (Pty) Ltd VWD89 Abitrexate 1g R 150.00 1 210 21 1 91.00 18-971-5286 VI


Page 6 of 8




Lead Time(Days)

Minimum Order

Quantity

Total Points


Unit of Measure


78 METHOTREXATE 2,5mg tablet, 100 tablets

132,894 Pharmachemie (Pty) Ltd VWD89 Abitrexate Tablets

R 61.08 1 126 21 1 91.00 18-975-2693 CO

79 METHOTREXATE 500mg injection, vialFor IV infusion

3,950 Pharmachemie (Pty) Ltd VWD89 Abitrexate 500mg R 128.75 1 96 21 1 91.00 18-971-0724 VI

80 METHOTREXATE 50mg injection, ampoule/vial

21,410 Pharmachemie (Pty) Ltd VWD89 Abitrexate 50 R 25.54 1 210 21 1 91.00 18-971-5285 VI

81 METHOTREXATE 5g injection, vialFor IV infusion

977 Pharmachemie (Pty) Ltd VWD89 Abitrexate 5g R 750.10 1 352 21 1 91.00 18-971-4911 VI

85 MYCOPHENOLATE MOFETIL 200mg/ml suspension, 165ml bottle

101 Roche Products (Pty) Ltd V2177 Cellcept 165ml Suspension

R 1,254.79 1 80 21 1 93.00 18-181-8341 BT

86 MYCOPHENOLATE MOFETIL 250mg capsule, 100 capsules

14,408 Roche Products (Pty) Ltd V2177 Cellcept 250mg R 331.20 100 78 21 1 93.00 18-030-0085 CO

87 MYCOPHENOLATE MOFETIL 500mg tablet, 50

29,062 Sandoz SA (Pty) Ltd VVZ69 Mycocept 500mg 50FCT ZA

R 199.16 1 144 21 1 94.00 18-182-0031 CO

88 MYCOPHENOLIC ACID 180mg enteric coated tablet, 120

788 Novartis South Africa (Pty) Ltd VBVW2 Myfortic 180mg tablet

R 432.00 1 40 21 1 93.00 18-183-5259 CO

89 MYCOPHENOLIC ACID 360 mg enteric coated tablet, 120

866 Novartis South Africa (Pty) Ltd VBVW2 Myfortic 360mg tablet

R 864.00 1 18 21 1 93.00 18-181-3273 CO

90 NILOTINIB 200 mg capsules, 112 capsules

3,500 Novartis South Africa (Pty) Ltd VBVW2 Tasigna 200mg R 1,639.33 1 40 21 1 93.00 18-186-6360 CO

91 ONDANSETRON 4mg dispersible tablet, 10 tablets

3,386 Pharmacare Ltd V2205 Zofran Zydis 4mg Tablets 10's


21 30 98.00 18-095-4155 CO

92 ONDANSETRON 4mg injection, 2ml ampoule for IV infusion

34,502 Accord Healthcare (Pty) Ltd V2MB8 Alepet 4 R 3.99 5 90 21 10 90.00 18-007-3817 AM

93 ONDANSETRON 4mg tablet, 15 tablets 3,157 Cipla Medpro South Africa Ltd VXZ32 Cipla-Ondansetron 4

R 19.76 1 400 21 100 99.00 18-185-8254 CO


Page 7 of 8




Lead Time(Days)

Minimum Order

Quantity

Total Points


Unit of Measure


94 ONDANSETRON 8mg dispersible tablet, 10 tablets

5,062 Pharmacare Ltd V2205 Zofran Zydis 8mg Tablets 10's


21 5 98.00 18-095-4156 CO

95 ONDANSETRON 8mg injection, 4ml ampoule For IV infusion

186,861 Litha Pharma (Pty) Ltd VGS73 Zofer R 6.75 8mg Injections 5 x 4ml

Ampoules

30 21 50 94.00 18-007-3819 AM

97 OXALIPLATIN 100mg injection for infusion

11,538 Accord Healthcare (Pty) Ltd V2MB8 Intas Oxaliplatin 100

R 798.00 1 80 21 10 90.00 18-180-4852 VI

98 OXALIPLATIN 50mg injection for infusion

2,654 Accord Healthcare (Pty) Ltd V2MB8 Intas Oxaliplatin 50

R 399.00 1 60 21 10 90.00 18-180-4849 VI

99 PACLITAXEL (concentrate) 100mg injection, vialFor IV infusion with giving setItem 99 & 100 may be considered as a series

20,588 Pharmachemie (Pty) Ltd VWD89 PCH-Paclitaxel 100

R 143.13 1 96 21 1 42.49 18-027-0223 VI

100 PACLITAXEL (concentrate) 30mg injection, 5ml vialFor IV infusion with giving setItem 99 & 100 may be considered as a series

210 Pharmachemie (Pty) Ltd VWD89 PCH-Paclitaxel 30 R 85.72 1 210 21 1 91.00 18-013-8165 VI

101 RITUXIMAB 100mg injection, 10ml vial for infusion

4,299 Roche Products (Pty) Ltd V2177 Mabthera 100 R 1,589.99 2 84 21 2 93.00 18-175-2974 VI

102 RITUXIMAB 500mg injection, 50ml vial for infusion

3,307 Roche Products (Pty) Ltd V2177 Mabthera 500 R 7,950.01 1 84 21 1 93.00 18-066-9542 VI

103 SIROLIMUS 1mg tablet, 30 tablets 9,422 Pfizer Laboratories (Pty) Ltd V2189 Rapamune 1mg Tablets

R 1,473.59 30 10 21 1 92.00 18-175-6276 CO

104 TACROLIMUS 1mg capsule, 100 capsules

17,666 Astellas Pharma (Pty) Ltd V0L15 Prograf 1mg 100's

R 1,791.73 1 x 100's 100 x 100's 21 1 90.00 18-034-3642 CO

105 TACROLIMUS 5mg capsule, 50 capsules 6,622 Astellas Pharma (Pty) Ltd V0L15 Prograf 5mg 50's R 4,332.65 1 x 50's 100 x 50's 21 1 90.00 18-094-8519 CO


Page 8 of 8




Lead Time(Days)

Minimum Order

Quantity

Total Points


Unit of Measure


107 TAMOXIFEN CITRATE equivalent to TAMOXIFEN 20mg tablet, 30 tablets

125,068 Pharmachemie (Pty) Ltd VWD89 Tamoplex 20mg R 13.29 30 1 21 1 91.00 18-971-4588 CO

109 THIOGUANINE 40mg tablet, 25 tablets 1,045 Pharmacare Ltd V2205 Lanvis 40mg Tablets 25's

R 1,700.03 25 Tablets 18 x 10 x 25 Tablets

21 1 98.00 18-971-2247 CO

112 VINBLASTINE SULPHATE 10mg injection, vial

8,264 Pharmachemie (Pty) Ltd VWD89 Vinblastine PCH R 81.98 1 210 21 1 91.00 18-096-9693 VI

113 VINCRISTINE SULPHATE 1mg injection, 1ml vial

5,051 Pharmachemie (Pty) Ltd VWD89 Abic Vincristine 1mg

R 36.80 1 210 21 1 91.00 18-971-0631 VI

114 VINCRISTINE SULPHATE 1mg/ml injection, 2ml vial

34,594 Pharmachemie (Pty) Ltd VWD89 Abic Vincristine 2mg

R 45.05 1 210 21 1 91.00 18-971-0632 VI

115 VINORELBINE 10mg injection, 1ml vial 1,921 Cipla Medpro South Africa Ltd VXZ32 Cipla-Vinorelbine 10mg

R 81.42 1 360 21 5 99.00 18-022-1922 VI

116 VINORELBINE 50mg injection, 5ml vial 5,174 Cipla Medpro South Africa Ltd VXZ32 Cipla-Vinorelbine 50mg

R 404.68 1 180 21 1 99.00 18-022-1924 VI

117 ZOLEDRONIC ACID 4mg/5ml, vial 24,358 Novartis South Africa (Pty) Ltd VBVW2 Zometa 4mg/5ml vial

R 311.89 1 210 21 1 93.00 18-184-4609 VI

Special Requirements and Conditions of Contract

HP04-2014ONC

THE SUPPLY AND DELIVERY OF ONCOLOGY AGENTS TO THE DEPARTMENT OF HEALTH

FOR THE PERIOD 1 APRIL 2014 TO 31 MARCH 2016

VALIDITY PERIOD 120 DAYS

National Department of Health

Non-compulsory Briefing Session: Date: 8 Nov 2014

Time: 10:00-11:00

Venue: Department Of National Health, 242 Struben Street (Cnr Thabo Sehume and

Struben streets) Civitas Building, Impilo Boardroom, Pretoria

37

2

INDEX

1. BACKGROUND ...................................................................................................................................................... 4

2. EVALUATION CRITERIA ....................................................................................................................................... 4

2.1 PREFERENCE POINTS SYSTEM .......................................................................................................................... 4

3. PRE AWARD SUPPLIER DUE DILIGENCE........................................................................................................... 6

4. PARTICIPATING AUTHORITIES............................................................................................................................ 6

4.1 POST AWARD PARTICIPATION...........................................................................................................................6

5. CONTRACT PERIOD ............................................................................................................................................ 6

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

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

8. TAX CLEARANCE CERTIFICATE . ..................................................................................................................... 7

9. AUTHORISATION DECLARATION ....................................................................................................................... 7

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

9.2 LEGISLATIVE REQUIREMENTS ........................................................................................................................... 8

10. CONTRACT ADMINISTRATION............................................................................................................................. 9

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

12. PROHIBITION OF RESTRICTIVE PRACTICES .................................................................................................. 10

13. FRONTING ........................................................................................................................................................... 11

14. PRODUCT COMPLIANCE ................................................................................................................................... 11

14.1 PRE AWARD PRODUCT COMPLIANCE PROCEDURES ................................................................................ 11

14.2 SAMPLES ............................................................................................................................................................. 11

15. AWARD CONDITIONS ......................................................................................................................................... 12

16. PRICE QUALIFICATION ...................................................................................................................................... 15

16.1 PRICING STRUCTURE ....................................................................................................................................... 15

16.2 PRICE REVIEW ..................................................................................................................................................... 15

16.3 SYSTEMATIC REVIEW OF MARKETPLACE ...................................................................................................... 16

17. QUANTITIES, ORDERS AND DELIVERY ........................................................................................................... 16

17.1 DELIVERY COMPLIANCE ................................................................................................................................... 16

17.2 QUANTITIES AND ORDERS ............................................................................................................................... 17

3

Special Requirements and Conditions of Contract HP04-2014ONC

17.3 MANUFACTURING INFORMATION..................................................................................................................... 18

18. PACKAGING ........................................................................................................................................................ 18

19. LABELS AND PACKAGE INSERTS .................................................................................................................... 20

20. CONTAINERS ....................................................................................................................................................... 20

21. STERILITY............................................................................................................................................................. 20

22 BARCODES .......................................................................................................................................................... 20

23. QUALITY .............................................................................................................................................................. 20

24 SHELF-LIFE .......................................................................................................................................................... 20

25. POST AWARD ...................................................................................................................................................... 21

25.1 REGISTRATION ON PROVINCIAL SUPPLIER DATABASES ............................................................................ 21

25.2 MERGERS, TAKE OVERS AND CHANGES IN SUPPLIER DETAIL .................................................................. 21

25.3 THIRD PARTIES .................................................................................................................................................. 22

25.4 MONITORING ....................................................................................................................................................... 22

25.5 REPORTING ......................................................... ............................................................................................... 22

26. CONTACT DETAILS ........................................................................................................................................... 23

27. ABBREVIATIONS ............................................................................................................................................... 23

4


SPECIAL CONDITIONS OF CONTRACT

1. BACKGROUND

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 as amended (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

2.1 PREFERENCE POINTS SYSTEM

a. In terms of regulation 6 of the Preferential Procurement Regulations pertaining

to the Preferential Procurement Policy Framework Act, 2000 (Act 5 of 2000),

responsive bids will be adjudicated by the Department of Health on the 90/10-

preference point system in terms of which points are awarded to bidders on the

basis of:

- The bid price (maximum 90 points)

- B-BBEE status level of contributor (maximum 10 points)

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

Pt - Ps = 90 1- P min

P min

Where

Ps = Points scored for comparative price of bid under consideration

Pt = Comparative price of bid under consideration

Pmin = Comparative price of lowest acceptable bid

A maximum of 10 points may be allocated to a bidder for attaining their 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 parts of the bid

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 points for B-BBEE.

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

the drawing of lots.

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

did not score the highest number of points.

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

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

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: Eastern Cape, Free State, Gauteng, KwaZulu-

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

4.1 POST AWARD PARTICIPATION

Treasury Regulation in terms of the Public Finance Management Act, 1999,

Section 16A6.6 states that the Accounting Officer/Accounting Authority may,

on behalf of the department, constitutional institution or public entity, 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.

The NDOH favours the participation of other departments, constitutional

institutions or public entities in this contract and intents to readily agree to

requests to participate. The NDOH expects successful bidders to also respond

favourably to such requests.

5. CONTRACT PERIOD

The contract period shall be for a period of 24 months commencing 1 April

2014 to 31 March 2016

6. DOCUMENT COMPLETION AND SUBMISSION

Bidders must submit responsive bids by completing all the mandatory

documents as well as the response fields for each individual item for which a bid

is submitted. This must also include the pricing component structure. Bid prices

submitted must match the unit in each individual specification.


7

It is mandatory that a completed signed hard copy of the entire bid document be

submitted, which will be regarded as the valid bid. Incomplete Bid documents

may render the bid to be non-responsive.

Bidders are also required to submit the completed Bid Response Document in

Excel format on a CD.

Failure to submit a valid B-BBEE certificate will result in no points being scored

for this component – see paragraph 2.1 b.

Failure to submit a valid Tax Clearance Certificate will render the bid non-

responsive (See paragraph 8).

All above-mentioned requirements must be complied with at the close of bid.

Note, no further amendments will be entertained.

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. It is obligatory that the

validity of the Tax Clearance Certificate should be maintained throughout the

duration of the contract.

9. AUTHORISATION DECLARATION AND LEGISLATIVE REQUIREMENTS

9.1 DECLARATION OF AUTHORISATION

a. In the event of the bidder not being the actual manufacturer in South Africa and will be importing the product(s) from another company, a signed

8


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 the bid at closing date and time of the bid. The Bid Authorization Form (PBD1) must be completed,

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 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.

d. Failure to submit a duly completed and signed Authorisation Declaration, where applicable, may invalidate the bid for such goods offered.

e. 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 reserves the right not to consider the bid or cancel the contract.

f. Notwithstanding sections a to e above, all accountability with regard to meeting the

conditions of this contract rests with the bidder.

9.2 LEGISLATIVE REQUIREMENTS

a. The bidder offering medicines in terms of this bid must be licensed with the Medicines Control Council (MCC) in terms of section 22C (1) (b) of the Medicines and Related Substances Act, Act 101 of 1965, as amended, and must be the holder of the license according to section 22C (6) of the said Act. A certified copy of the license including all annexures thereto must be submitted with the bid document..

b. Medicines offered by bidders must be registered in terms of section 15 of the Medicines and Related Substances Act, Act 101 of 1965 as amended, and bidders must indicate on the item response field the registration number of such an item in terms of the said Act. The medicines must comply with the conditions under which the medicine is registered at the closing date and time of bid.

9


c. Certified copies of product registration certificates with the MCC should

accompany the bid. d. The bidder must submit proof of current GMP compliance of all manufacturing,

packing and laboratory sites used for each product and disclose any notice of deviation from GMP received from the MCC.

e. The registered package insert for each item offered must be included with the bid document, as well as with samples submitted

f. Non-compliance with the above mentioned legal requirements may invalidate the bid for such products offered.

10. CONTRACT ADMINISTRATION

a. Contracted suppliers must advise the Director: Affordable Medicines within 7

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.

b. The administration and facilitation of the contract will be the responsibility of the

National Department of Health and all correspondence in this regard must be

directed to the contact persons listed in Section 26.

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 in

writing.

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

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

the award of the bid by the bidder is discouraged.

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

participation in future Department of Health contracts.

11. COUNTER CONDITIONS

Any amendments to any of the Bid Conditions, changes to bid specifications or setting of counter conditions by bidders may result in the invalidation of such bids.

10


12. PROHIBITION OF RESTRICTIVE PRACTICES

a. In terms of section 4 (1) of the Competition Act No. 89 of 1998, as amended, an

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

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

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

i.) directly or indirectly fixing a purchase or selling price or any other trading

condition;

ii.) dividing markets by allocating customers, suppliers, territories or specific

types of goods or services; or

iii.) collusive bidding.

b. Section 4 (2) of Act No.89 of 1998 as amended 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:

i) any one of those firms owns a significant interest in the other, or they

have at least one director or substantial shareholder in common; and

ii) any combination of those firms engages in that restrictive horizontal

practice.

c. If a bidder(s) or contractor(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

No. 89 of 1998.

d. If a bidder(s) or contractor(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 contractor(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 contractor(s) concerned.

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13. 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.

14. PRODUCT COMPLIANCE

14.1 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. Certified copy of product registration with Medicines Control Council (MCC).

c. Valid relevant licence from Medicines Control Council with relevant annexures..

d. Submission of samples of the relevant products on or before the closing date and time

of the bid at the addresses indicated below.

14.2 SAMPLES

a. No samples must be sent to the Directorate Affordable Medicines.

b. Samples must be submitted to each of the addresses indicated below, to be received

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before or at closing date and time of bid:

Mr Dumisani Malele Ms Helen Hayes

Tel: 011 628 9001 Tel: 021 483 4567

Gauteng: Medical Supplies Depot Western Cape: Department of Health

Store 3 Pharmaceutical Services

35 Plunkett Avenue 4 Dorp Street Room T14-02

Hurst Hill Cape Town

2092 8001

c. For accurate evaluation of samples, bidders must submit at least one original pack of

each offer.

d. Bids where samples were not submitted will not be considered for award.

e. Samples must be marked with the bid number, the item number as well as the bidder’s

name and address.

f. It is the responsibility of the bidders to ensure receipt of the samples at the addresses

listed in Section 14.2 (b).

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

h. Samples submitted by unsuccessful bidders must be collected by them within 3 months

of the commencement of the contract. Samples not collected within this 3 month period

will be destroyed.

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

j. All samples must be submitted with the MCC approved package insert.

k. Samples must comply with all legal prescripts. 15. AWARD CONDITIONS

a. The Department of Health reserves the right to issue split awards where necessary to

ensure security of supply.

b. Dual awards

Split awards between 2 bidders will be made in accordance with the following

schedule based on the points scored:

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Category

Difference

between points

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

c. The following conditions will apply to split awards:

� A single bidder will not be awarded more than one portion for the same line item.

� The Department of Health reserves the right not to split award amongst bidders

using the same API source and / or manufacturer.

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

tender does not achieve the most economically advantageous price

e. In order to determine the most economically advantageous option, the points scored of

the following groups of line times will be compared to each other and a single line item

from each group may be awarded:

Item No. 1 Anastrazole 1mg tablets 30s

Item No. 70 Letrozole 2.5mg tablet, 30’s

AND

Item No. 5 Bicalutamide 50mg tablet, 30s

Item No. 47 Flutamide 250mg tablet, 100s

AND

Item No. 7 Buserelin Acetate 9.9mg equivalent to Buserelin Base 9,45mg injectable depot implant, single disposable applicator

Item No. 50 Goserelin 10.8mg injection

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AND

Item No. 52 Granisetron 1mg tablet, 10s

Item No. 96 Ondansetron 8mg tablet, 15s

AND

Item No. 53 Granisetron 1mg/ml injection, 3ml ampoule For IV infusion

Item No. 95 Ondansetron 8mg injection, 4ml ampoule For IV infusion

AND

Item No. 55 Ibandronic Acid 2mg/2ml injection, ampoule

Item No. 117 Zoledronic Acid, 4mg/5ml, vial

AND

Items No. 60 Imatinib Mesilate 100 mg tablet, 60s

& No. 61 Imatinib Mesilate 400 mg tablet, 30s

vs.

Item No. 90 Nilotinib 200 mg capsule, 112s

For therapeutic classes the Department of Health reserves the right to award split

awards across a class. f. The Department of Health reserves the right to change drug regimens and/or product

formulations if necessary due to emerging clinical evidence, disease profiles, reported

adverse drug reactions or resistance patterns.

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16. PRICE QUALIFICATION AND CONTRACT PRICE ADJUSTMENT PROCEDURE

16.1 PRICING STRUCTURE

a. Prices submitted for this bid will be regarded as firm and subject only to review in terms

of Section 17.2

b. Bidders must quote a final delivered price inclusive of Value Added Tax,

c. Bidders are advised to refer to the Reference Price List for HP04-2014ONC, Oncology

Medicines as published on the Department of Health website (www.doh.gov.za) before

preparing the bid submission.

d. Final price must include API price, formulation cost, packaging cost, transport cost,

indicating the imported and local proportions of each component as per table below

and Value added Tax etc. Bidders are referred to the pricing schedule in this regard.

16.2 PRICE REVIEW

a. The Department of Health envisages 2 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 practises.

� A systematic review of prices for comparable products available publicly in the international marketplace.

b. Schedule for Price Review:

Review Average exchange rates for the period:

Submission of data for price review to reach the office by the following dates

Dates from which adjusted prices will become effective

1 1 November 2013 – 31 August 2014

7 Sep 2014 1 Oct 2014

2 1 September 2014 – 28 Feb 2015

7 March 2015 1 April 2015

3 1 March 2015 – 31 August 2015

7 September 2015 1 October 2015

c. Contract price reviews based on average exchange rates as published by the Reserve Bank for the periods indicated above.

d. Only the imported cost component of the bid price will be adjusted taking into account

the base RoE and the average RoE over the period under review

http://www.doh.gov.za/

16


Currency Rates of exchange Average for the period 1 April 2013 to

30 September 2013 Dollar R 9.2438

Br Pound R 14.1371

Euro R 12.0144

e 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 April 2013 to 30 September 2013 using the South African Reserve Bank published rates for the specific currency. Visit www.reservebank.co.za to obtain the relevant rates.

f. The review of the price adjustment for rate of exchange is applied from the base RoE.

g. Where no adjustment relating to Rate of Exchange has been applied for, and it is in the favour of the Department, this will automatically be effected.

h. Rate of Exchange increases may not result in a price exceeding the ruling Single Exit

Price.

16.3 SYSTEMATIC REVIEW OF MARKETPLACE

The National Department of Health reserves the right to:

a. perform a market review of the international pharmaceutical industry to ensure

continued competitiveness of pricing.

b. Compare prices internationally with global most favoured nation pricing.

c. Should the review identify that contract prices are unfavourable; the Department of

Health will contact and enter into price negotiations with the contracted supplier.

17. QUANTITIES, ORDERS AND DELIVERY

17.1 DELIVERY COMPLIANCE

a. For each product, bidders must explicitly indicate the minimum and maximum

volumes that they can supply on a monthly, quarterly (3-monthly) and annual

basis on the response fields.

b. Bidders must maintain regular supplies throughout the duration of the contract.

c. Bidders must adhere to delivery lead time (time from placement of order to

delivery) as quoted in bid documents. This may not be longer than 3 weeks (21 calendar days).

http://www.reservebank.co.za/

17


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

calculated from date of award and NOT the first order. This may not exceed 60

calendar days from the date of award.

e. Failure to meet lead time requirements of 21 days will result in bids not being

considered.

f. Bidders must make delivery of products in accordance with the instructions

appearing on the official order forms emanating from Participating Authorities and

institutions placing the orders.

g. All deliveries or dispatches must be accompanied by a delivery note stating the

official order number against which the delivery has been effected.

h. The instructions appearing on the official order form regarding the supply,

dispatch and submission of invoices must be strictly adhered to.

i. 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.

j. Deliveries must be in accordance with official orders and any deviation will be

returned to the contractor at the contractor’s expense.

k. Suppliers must accept delivery discrepancy reports for credit claims for at least 48

hours after delivery to final destination. This will thus enable cross-docking and

direct delivery processes.

l. Deliveries must conform to cold chain distribution requirements, if applicable.

Normal storage conditions (25 degrees Celsius) must not be exceeded.

17.2 QUANTITIES AND ORDERS

a. The quantities reflected in the bid documents are estimated volumes for the basis

of determining a bid price and as such cannot be guaranteed in terms of final award

and procurement. During the award process and during the contract period, volumes

may be varied according to:

� Splitting award between suppliers

� Therapeutic alternatives may influence quantities awarded

� Revision and implementation of Standard Treatment Guidelines

� Programmatic considerations b. Monthly requirements will not be constant. The Department will meet with contracted

suppliers quarterly to review supply performance and ongoing requirements

c. The Department of Health is under no obligation to purchase any stock, which is in


bulk storage according to Good Wholesaling Practice and Good Distribution

18

excess of the indicated quantities for any item

d. Bidders should note that order(s) will be spread out throughout the contract

period.

e. Minimum order quantities should enable deliveries directly to individual hospitals.

Delivery points will be to individual hospitals and in some cases to Provincial

Depots. Failure by bidders to meet the minimum order quantity requirements

may result in bids not being considered for award.

f. Suppliers must under no circumstances deviate from orders issued by the

departments.

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

during the contract period.

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

outside of the contract :

� If the contractor fails to perform � If the item(s) are urgently required and not immediately available � If an emergency arises

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

time exceeds the delivery lead time as in the final contract:

17.3 MANUFACTURING INFORMATION a. Bidders must disclose the manufacturing site(s) as well as the API supplier(s), as

approved by the MCC.

b. Bidders must be able to substantiate the API price provided when requested

c. Bidders must disclose future production plans

d. Bidders must disclose their ability to maintain buffer stock within the country.

e. The Department of Health reserves the right to negotiate with bidders or pass over a bid

if the above could adversely affect security of supply

18. PACKAGING a. Suppliers must ensure that supplies delivered are received in good order at the

point of delivery. Packaging must be suitable for further dispatch as well as


19

Practice.

b. All packaging must meet safety standards for transportation of oncology products.

c. The number of “PACK” items in the commercial packing must appear on the bid

documents. The packing must be uniform for the duration of the contract

period i.e

� The number of “PACK” items per commercial packing. The number of commercial

packing per carton.

� The number of cartons per bulk packing.

� The name and quantity of the contents must appear clearly on the packing

� All containers, packing and cartons must be clearly labeled.

� All products must be packed in acceptable containers, where applicable, specifically developed for the product.

c. The following information must be clearly and indelibly printed on all inner and

outer bulk packing in letters not less than 10mm in height:

� The proprietary name and quantity of the contents and expiry date if

applicable must appear clearly on the packing.

� Date of manufacture.

� The number of commercial packing per carton. The number of cartons per bulk

packing.

� The conditions under which the product must be stored.

� The name and quantity of the contents must appear clearly on the packing

� All containers, packing and cartons must be clearly labeled.

� All products must be packed in acceptable containers, where applicable, specifically developed for the product.

d. The following information must be clearly and indelibly printed on all inner and

outer bulk packing in letters not less than 10pt in height:

� Product detail e.g. name, size, quantity etc. � Date of manufacture. � Batch number. � Expiry date.

e. The Department of Health reserves the right to change drug regimens and/or product

formulations if necessary due to emerging clinical evidence, disease profiles,

reported adverse drug reactions or resistance patterns.


20

19. LABELS AND PACKAGE INSERTS

a. Labels and package inserts for medicines must comply with the Medicines and Related

Substances Act, 1965 (Act 101 of 1965) as amended.. 20. CONTAINERS

The function of a container for a medicinal preparation is to maintain the quality, safety and

stability of its contents. Special care should be taken to ensure that containers of cytotoxic

products withstand the mechanical hazards of handling and transport, prevent leakage, and

provide an appropriate level of protection from environmental conditions. The condition of

container must be acceptable to purchaser at the point of delivery. Ideally, the materials of

construction should have no chemical or physical effect on the preparation, and, for liquid

preparations, should be sufficiently transparent to permit inspection..

21. STERILITY

All solutions and injectable preparations are to be supplied sterile and apyrogenic

22. BARCODES

a. It is mandatory that all products supplied must include a barcode (number

plus symbology). Both the outer case and the specification pack must be marked with

the appropriate number and symbology. The European Article Numbering Code 13 (EAN

13) has been accepted as standard 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. 23. QUALITY

a. Products supplied in consequence of this bid must conform in every aspect with the

conditions of registration lodged with Medicines Control Council 24. SHELF-LIFE

a. Products, upon delivery, must have at least 18 months of shelf-life before date of


21

expiry.

b. Contractors may make written applications to deliver material with a shorter shelf-

life, provided that:

� applications are accompanied by an undertaking that such short-dated stock will be

unconditionally replaced before or after expiry

� that such applications are approved before execution of the orders.

� An undertaking is included that the following discount formula be applied for

invoicing of short-dated stock:

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

Therefore, amount to be invoiced is: Consignment value – A, where A is the

discount formula.

� Any delivery of short dated supplies without prior written approval must be

collected by the respective suppliers at their own cost. Failure to comply within

30 days after written advice will result in the disposal of such supplies for the

account of the supplier.

c. Any participating authority may, without prejudice, decline to accept stock with a

shelf -life of less than 18 months

25. POST AWARD

25.1 REGISTRATION ON PROVINCIAL SUPPLIER DATABASES

a. All contracted suppliers must ensure that they register with individual provinces on their

supplier databases within 30 days after award of contract.

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

contracts

25.2 MERGERS, TAKE OVERS AND CHANGES IN SUPPLIER DETAIL

a. 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.

b. 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.

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


22

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

25.3 THIRD PARTIES

a. Participating authorities will not make a payment to or consult regarding orders with a

third party.

b. No third party is entitled to put an account on hold.

25.4 MONITORING

a. The contractors must confirm compliance with the Good Manufacturing Practice. Any

change in the said status during the contract period must be reported within seven (7)

days of receipt of such notice from the Medicines Control Council to the Department.

b. All Contractors shall be required to attend quarterly tender review and supplier

performance meetings with the National Department of Health. c. 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:

i) compliance to delivery lead times,

ii) 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) , iii) compliance with reporting requirements and schedule

iv) attendance of quarterly review meetings.

25.5 REPORTING

a. Suppliers 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].

mailto:[email protected]


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26. CONTACT DETAILS

Directorate: 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]

Mr R Kettledas:

Tel: (012) 395 9529

Fax: (012) 395 8823

Ms B May:

Tel: (012) 395 8442

Fax: (012) 395 8823

Ms Phuti Moloko:

Tel: (012) 395 8439

Fax: (012) 395 8823

27. ABBREVIATIONS

The abbreviations used in this bid signify the following:

BEC B-BBEE

= =

Bid Evaluation Committee Broad Based Black Economic Empowerment

GMP = Good Manufacturing Practice MCC = Medicines Control Council NDoH = National Department of Health SBD = Standard Bidding Document VAT = Value- Added Tax

mailto:[email protected]

hp04-2014onc contract circular period: 1 april 2014 to 31 march 2016 page 1 of 8 no. description

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