1. NEW NAMIBIA MEDICINES CONTROL ACT SAPRAA meeting 5 September 2008 Presented by: Johannes Gaeseb Registrar of Medicines NAMIBIA

2. BACKGROUND Before independence all RSA laws were applicable in Namibia Before independence all RSA laws were applicable in Namibia All medicines regulated in RSA, applicable automatically in Namibia All medicines regulated in RSA, applicable automatically in Namibia After independence, March 1990, only the medicines regulatory laws as amended in 1977 applicable in Namibia After independence, March 1990, only the medicines regulatory laws as amended in 1977 applicable in Namibia Namibia to amend Act 101 of 1965 to take over the medicines registered before 1990 Namibia to amend Act 101 of 1965 to take over the medicines registered before 1990

3. BACKGROUND There was a need to update the medicines control legislation: There was a need to update the medicines control legislation: Act 101 of 1965 was outdated Act 101 of 1965 was outdated New developments in the pharmaceutical sector, i.e. counterfeiting, TRIPS New developments in the pharmaceutical sector, i.e. counterfeiting, TRIPS National Drug Policy of 1998 National Drug Policy of 1998

4. LEGISLATION MEDICINES AND RELATED SUBSTANCES CONTROL ACT,2003 (ACT 13 OF 2003) MEDICINES AND RELATED SUBSTANCES CONTROL ACT,2003 (ACT 13 OF 2003) MEDICINES CONTROL AMENDMENT ACT, 2007 (ACT 8 OF 2007) MEDICINES CONTROL AMENDMENT ACT, 2007 (ACT 8 OF 2007) ACCOMPANYING REGULATIONS & MEDICINES SCHEDULES ACCOMPANYING REGULATIONS & MEDICINES SCHEDULES

5. MAIN CHANGES (1) Name change of the regulatory body from Medicines Control Council (MCC) to Namibia Medicines Regulatory Council (NMRC) Name change of the regulatory body from Medicines Control Council (MCC) to Namibia Medicines Regulatory Council (NMRC) Registration of Veterinary medicines Registration of Veterinary medicines Registration of Complementary medicines Registration of Complementary medicines Labeling requirements for medicines on the Namibian market Labeling requirements for medicines on the Namibian market

6. MAIN CHANGES (2) LABELLING REQUIREMENTS: LABELLING REQUIREMENTS: The following are to be on label: The following are to be on label: Registration number given by NMRC Registration number given by NMRC Namibian scheduling status Namibian scheduling status Both manufacturing and expiry dates must be on label Both manufacturing and expiry dates must be on label PATIENT INFORMATION LEAFLET PATIENT INFORMATION LEAFLET

7. MAIN CHANGES (3) MEDICINES SCHEDULES There are now SIX schedules instead of NINE: There are now SIX schedules instead of NINE: SCHEDULE 0 SCHEDULE 0 SCHEDULE1 SCHEDULE1 SCHEDULE2 SCHEDULE2 SCHEDULE3 SCHEDULE3 SCHEDULE4 SCHEDULE4 SCHEDULE5 SCHEDULE5

8. MAIN CHANGES (4) MANUFACTURERS TO REGISTER WITH NMRC MANUFACTURERS TO REGISTER WITH NMRC IMPORTERS & EXPORTERS MUST HAVE LICENCE IMPORTERS & EXPORTERS MUST HAVE LICENCE DISPENSING MEDICAL PRACTITIONERS TO HAVE A LICENCE DISPENSING MEDICAL PRACTITIONERS TO HAVE A LICENCE

9. MAIN CHANGES (5) PERSONS WHO MAY APPLY FOR REGISTRATION OF A MEDICINE PERSONS WHO MAY APPLY FOR REGISTRATION OF A MEDICINE A PERSON RESIDING AND DOING BUSINESS IN NAMIBIA A PERSON RESIDING AND DOING BUSINESS IN NAMIBIA A FOREIGN MANUFACTURER OF A MEDICINE A FOREIGN MANUFACTURER OF A MEDICINE A FOREIGN MANUFACTURER’S NOMINEE RESIDING IN NAMIBIA A FOREIGN MANUFACTURER’S NOMINEE RESIDING IN NAMIBIA A SUBSIDIARY OF A FOREIGN MANUFACTURER A SUBSIDIARY OF A FOREIGN MANUFACTURER HOLDER OF A PERMIT SECTION 31(4) OF THE ACT HOLDER OF A PERMIT SECTION 31(4) OF THE ACT ALL THOSE NOT RESIDING IN NAMIBIA MUST APPOINT A REPRESENTATIVE BASED IN NAMIBIA ALL THOSE NOT RESIDING IN NAMIBIA MUST APPOINT A REPRESENTATIVE BASED IN NAMIBIA

10. MAIN CHANGES (6) EXPEDITED REGISTRAION PROCESS: EXPEDITED REGISTRAION PROCESS: ESSENTIAL MEDICINES LIST ESSENTIAL MEDICINES LIST PUBLIC HEALTH JUSTIFICATION PUBLIC HEALTH JUSTIFICATION MEDICINES TENDERED INTERNATIONALLY BY THE STATE FOR SUPPLY TO STATE HEALTH FACILITIES MEDICINES TENDERED INTERNATIONALLY BY THE STATE FOR SUPPLY TO STATE HEALTH FACILITIES

11. MAIN CHANGES (7) ADVERTISEMENTS Advertisements of medicines to the public must be approved by NMRC Advertisements of medicines to the public must be approved by NMRC

12. MAIN CHANGES (5) FEES FEES APPLICATION FEE APPLICATION FEE INSPECTION FEE INSPECTION FEE REVISED REGISTRATION AND RETENTION FEES REVISED REGISTRATION AND RETENTION FEES

13. CONTACT DETAILS WEBSITE: www.nmrc.com.na WEBSITE: www.nmrc.com.nawww.nmrc.com.na E-mail: regmeds@nmrc.com.na / regmeds@cms-namibia.com E-mail: regmeds@nmrc.com.na / regmeds@cms-namibia.comregmeds@nmrc.com.na regmeds@cms-namibia.comregmeds@nmrc.com.na regmeds@cms-namibia.com Tel: +264 61 203 2400/03 Tel: +264 61 203 2400/03 Fax: +264 61 225 048 Fax: +264 61 225 048 Postal Address: Private Bag 13366, Windhoek Postal Address: Private Bag 13366, WindhoekNamibia

14. I THANK YOU