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Medicines and Related Substances Act, 1965 (Act 101 of 1965)

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Medicines and Related Substances Act, 1965 (Act 101 of 1965) STAATSKOERANT, 27 SEPTEMBER 2013 No. 36879 3 GENERAL NOTICE ALGEMENE KENNISGEWING NOTICE 963 OF 2013 MEDICINES CONTROL COUNCIL CONDITIONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONS OF SECTION 15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965) 1. The applicant shall ensure that the medicine is manufactured and controlled in terms of the current Good Manufacturing Practices as determined by Council 2. The manufacture of this medicine is subject to regular investigation and inspections by the inspectors appointed in terms of Section 26 of the Act, to assess compliance with current Good Manufacturing Practices. 3. The information in the package insert shall be updated on a regular basis to conform to the package insert recently approved by Council. 4. The applicant must comply with all the legal requirements of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). 5. The registration of this medicine shall be subject to review at intervals as determined by Council regardingitsquality, safety and efficacy, and the registration of this medicine may be varied subject to issues Council may deem fit. 6. The first two production batches must be fully validated in terms of the detailed process validation protocol submitted at the time of application for registration, and the validation report must be submitted within a month after completion of the validation. 7. The product may be advertised to the professions only. 8. The provisional shelf-life allocated must be confirmed with stability data over the full shelf-life period on the first two production batches (well-known API) or first three production batches (NCE) in accordance with the Stability Guideline. Stability testing submitted on any pilot batches must also be completed and reported on.The stability report must be submitted within six months after completion of the stability trial. However, Council has to be informed immediately if any parameter shows a significant change or out-of-specification result during the stability trial. 9. A post-registration inspection must be conducted on the first production batch manufactured by each local manufacturer. 10. A post-registration inspection must be conducted on the first production batch of the imported product. 11. Marketing of the product may only commence following a satisfactory post- registration inspection report. 12. One sample of every batch, together with four copies of the protocol for testing of the bulk lot and filling lot, and six copies of the certificate of release issued by a competent authority in the country in which the product was manufactured, must be submitted to the Council for lot release purposes. 13. The expiry date allocated shall be modified by adding a statement that the virus strains are currently recommended for South African usage in the specific year. 14. The strains of the master seed viruses must be approved by the Department of Health for each year. This gazette is also available free online at www.gpwonline.co.za MRFNameRegistration 15 of medicine: number: LILLY36/7.1.5/0385 TADALAFIL 20 mg MRF15NameRegistration of medicine: number: A39/32.11/0158REN-ACID SK-F 209 v1RF 15NameRegistration of medicine: number: A39/32.11/0159REN-ACID SK-F 207 LOW Ca'' ActiveDosage ingredients: form: TADALAFILEACHTABLET TABLET CONTAINS:20,0 mg ActiveDosage ingredients: form: CONTAINS:EACHDIALYSATE 1 000,0 ml SOLUTION ActiveDosage ingredients: form: CONTAINS:EACHDIALYSATE 1 000,0 ml SOLUTION This gazette isalsoavailable freeonline at SODIUMCALCIUMPOTASSIUMMAGNESIUM CHLORIDE CHLORIDE CHLORIDE CHLORIDE 214,87,718 5,222 3,558g g g g SODIUMCALCIUMPOTASSIUMMAGNESIUM CHLORIDE CHLORIDE CHLORIDE CHLORIDE 210,76,431 5,222 3,558g g g g Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: ACETIC1, 2, 3, 4, ACID 5, 6, 74,207 g Conditions of registration: 1,ACETIC 2, 3, 4, ACID5, 6, 7 6,311 g 27SEPTEMBER2013STAATSKOERANT, No.36879 Applicant:Manufacturer: CENTER,ELI LILLY INDIANAPOLIS,&(S.A.) Co, LILY(PTY) TECHNOLOGY LTD INDIANA, Manufacturer:Applicant: MANUFACTURINGFRESENIUS KABI SA (PTY) (PTY) LTD, LTD Manufacturer:Applicant: (PTY)FRESENIUS LTD, KORSTEN, KABI MANUFACTURINGSA (PTY) PORT LTD Packer: ELISPAINLILLYUSA LILLY SA, &ALCOBENDAS, Co LTD, BASINGSTOKE, MADRID, Packer: KORSTEN,MANUFACTURINGFRESENIUS PORT KABI ELIZABETH, (PTY) LTD, RSA Packer: ELIZABETH,(PTY)FRESENIUS LTD, KORSTEN, RSAKABI MANUFACTURING PORT Laboratory: FPRC: USACENTER,ELIHAMPSHIRE, LILLY INDIANAPOLIS,& Co, UK LILY TECHNOLOGY INDIANA, Laboratory: FPRC: KORSTEN,MANUFACTURINGFRESENIUS PORT KABI ELIZABETH, (PTY) LTD, RSA Laboratory: FPRC: ELIZABETH,(PTY)FRESENIUS LTD KORSTEN, RSAKABI MANUFACTURING PORT www.gpwonline.co.za CENTER,ELI LILLY INDIANAPOLIS,& Co, LILLY CORPORATE INDIANA, LABORATORIES,CONSULTINGHAMPSHIRE,ELIUSA LILLY & CO UK CHEMICAL LTD, ATLASVILLE, BASINGSTOKE, PRETORIA,DEPARTMENT,PHARMACEUTICALSABSBOKSBURG, COMMERCIAL RSA RSA GROENKLOOF, CHEMISTRY (PTY) LTD, FPRR: BRYANSTON,ELI LILLY (S.A.) JOHANNESBURG, (PTY) LTD, RSA FPRR: MANUFACTURINGFRESENIUS(PTY) LTD, HALFWAY KABI SOUTH (PTY) HOUSE, LTD, AFRICA RSA FPRR: (PTY)FRESENIUS LTD, KORSTEN,HALFWAY KABI MANUFACTURINGSOUTH HOUSE,PORT AFRICA RSA DateShelf-life: of registration: 1536 AUGUSTmonths 2013 DateShelf-life: of registration: 1524KORSTEN, monthsAUGUST PORT 2013 ELIZABETH, RSA DateShelf-life: of registration: 24ELIZABETH,15 monthsAUGUST 2013RSA 5 6 RegistrationMRF 15 number: A39/32.11/0160 RegistrationMRF15 number: A39/32.11/0404 vIRF 15 A39/32.11/0405 No. 36879 GAZETTE,27SEPTEMBER2013 GOVERNMENT NameDosage of form:medicine: DIALYSATEREN-ACID SK-F 203 DosageName of form: medicine: DIALYSATEREN-ACID SK-F 213 NameRegistration of medicine: number: DIALYSATECa"REN-ACID /GLUCOSE SK-F 219 LOW Active ingredients: CONTAINS:POTASSIUMMAGNESIUMEACH 1 000,0 CHLORIDECHLORIDEml SOLUTION 5,2223,558 g Active ingredients: POTASSIUMMAGNESIUMCONTAINS:EACH 1 000,0 CHLORIDEml SOLUTION 3,5585,222 g ActiveDosage ingredients: form: POTASSIUMMAGNESIUMCONTAINS:EACH 1 000,0 CHLORIDECHLORIDEml SOLUTION 5,2223,558 g This gazette isalsoavailable freeonline at ACETICSODIUMCALCIUM ACIDCHLORIDE CHLORIDE 6,311 210,7g 9,004 g g DEXTROSEACETICSODIUMCALCIUM ACIDCHLORIDE CHLORIDE MONOHYDRATE 6,311 210,7g 9,004 g g ACETICDEXTROSESODIUMCALCIUM ACIDCHLORIDE CHLORIDE MONOHYDRATE 6,311 210,7g 6,431 g g registration:Conditions of 1, 2, 3. 4 5, 6, 7 Conditions of 1,DEXTROSEEQUIVALENT 2, 3, 4, 5, 6,ANHYDROUS TO7, 8 38,5 g Conditions of 1,DEXTROSEEQUIVALENT 2, 3, 4, 5, 6,ANHYDROUS TO7, 8 38,5 g Manufacturer:Applicant: MANUFACTURINGFRESENIUS KABI SA (PTY) (PTY) LTD, LTD Manufacturer:Applicant:registration: MANUFACTURINGFRESENIUS KABI SA (PTY) (PTY) LTD, LTD Manufacturer:Applicant:registration: MANUFACTURINGFRESENIUS KABI SA (PTY) (PTY) LTD, LTD Packer: MANUFACTURINGFRESENIUSRSAKORSTEN, PORT KABI ELIZABETH, (PTY) LTD, Packer: MANUFACTURINGFRESENIUSKORSTEN, PORT KABI ELIZABETH, (PTY) LTD, RSA Packer: MANUFACTURINGFRESENIUSRSAKORSTEN, PORT KABI ELIZABETH, (PTY) LTD, www.gpwonline.co.za Laboratory: FPRC: FRESENIUSRSAKORSTEN, PORT KABI ELIZABETH, Laboratory: FPRC: FRESENIUSKORSTEN, PORT KABI ELIZABETH, RSA Laboratory: FPRC: FRESENIUSRSAKORSTEN, PORT KABI ELIZABETH, FPRR: FRESENIUSRSAKORSTEN,MANUFACTURING PORT KABI ELIZABETH,SOUTH (PTY) LTD, FPRR: FRESENIUSMANUFACTURINGKORSTEN, PORT KABI SOUTHELIZABETH, (PTY) LTD, AFRICA RSA FPRR: FRESENIUSRSAKORSTEN,MANUFACTURING PORT KABI ELIZABETH.SOUTH (PTY) LTD, MANUFACTURINGAFRICAKORSTEN,FRESENIUSHOUSE, (PTY)RSA PORT KABI LTD, ELIZABETH, (PTY) HALFWAY LTD, MIDRAND,(PTY) LTD INDUSTRIARSA PARK, PARK,AFRICA MIDRAND, (PTY) LTD RSA INDUSTRIA Shelf-life:Date of registration: 2415RSA monthsAUGUST 2013 DateShelf-life: of registration: 2415 monthsAUGUST (Provisional) 2013 DateShelf-life: of registration: 1524 AUGUSTmonths (Provisional) 2013 RegistrationMRF 15 number: 41/11.4.3/0099 MRF15Registration number: 42/7.1.3/0115 ORE 15 Registration number: 42/7.1.3/0116 NameDosage of form:medicine: TABLETPEPTAZOL 40 DosageName of form: medicine: TABLET(TABLET)COIRBESARTAN WINTHROP 300/25 DosageName of form: medicine: TABLETSARBEN HCTZ 300/25 (TABLET) Active ingredients: PANTOPRAZOLEEQUIVALENTSESQUIHYDRATEEACH TABLET TO CONTAINS: SODIUM40,0 mg Active ingredients: HYDROCHLOROTHIAZIDEIRBESARTANEACH TABLET 300,0 CONTAINS: mg 25,0 mg Active ingredients: HYDROCHLOROTHIAZIDEIRBESARTANEACH TABLET 300,0 CONTAINS: mg 25,0 mg This gazette isalsoavailable freeonline at Applicant:registration:Conditions of PHARMACO1, 2, 3, 4, 5, 6, DISTRIBUTION 7 Applicant:registration:Conditions of SANOFI-AVENTIS1, 2, 3, 4, 5, 6, 7 SOUTH AFRICA (PTY) Applicant:Conditions of registration: SANOFI-AVENTIS1, 2, 3, 4, 5, 6, 7 SOUTH AFRICA (PTY) LTD LTD (PTY) LTD 27SEPTEMBER2013STAATSKOERANT, No.36879 Packer:Manufacturer: BUENOSQUIMICA AIRES,MONTPELLIER ARGENTINA S.A., Packer:Manufacturer: CARBONSANOFI WINTHROP BLANC CEDEX, INDUSTRIE, FRANCE Packer:Manufacturer: CARBONSANOFI WINTHROP BLANC CEDEX, INDUSTRIE, FRANCE WEST,PHARMA-Q, JOHANNESBURG, INDUSTRIA RSA WEAR,SANOFI-SYNTHELABOHUNGARYCHINOINNEWCASTLE-UPON-TYNE, UK Co. LTD, VERESEGYHAZ, LIMITED, TYNE & HUNGARYCHINOINWEAR,NEWCASTLE-UPON-TYNE.SANOFI- UK SYNTHELABO Co. LTD, VERESEGYHAZ, LIMITED, TYNE & WINTHROP(PTY)PHARMACEUTICALLTD, WALTLOO, LTD, ISANDO,PHARMACEUTICALS PRETORIA, CONTRACTORSRSA RSA (PTY) (PTY)PHARMACEUTICALRSAWINTHROP LTD, ISANDO,WALTLOO, PHARMACEUTICALS CONTRACTORSRSA PRETORIA, www.gpwonline.co.za Laboratory: FPRC: PHARMA-Q,BUENOSQUIMICA AIRES,MONTPELLIER INDUSTRIA ARGENTINA S.A., Laboratory: FPRC: SANOFI-SYNTHELABOCARBONSANOFI
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