1. NEW NAMIBIA MEDICINES CONTROL ACT SAAPI meeting 4 September 2008 Presented by: Johannes Gaeseb Registrar of Medicines NAMIBIA

2. BACKGROUND • Before independence all RSA laws were applicable 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 • 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 BACKGROUND • There was a need to update the medicines control legislation: • Act 101 of 1965 was outdated • New developments in the pharmaceutical sector, i.e. counterfeiting, TRIPS • National Drug Policy of 1998

4. LEGISLATION • MEDICINES AND RELATED SUBSTANCES CONTROL ACT,2003 (ACT 13 OF 2003) • MEDICINES CONTROL AMENDMENT ACT, 2007 (ACT 8 OF 2007) • 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) • Registration of Veterinary medicines • Registration of Complementary medicines • Labeling requirements for medicines on the Namibian market

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

7. MAIN CHANGES (3)MEDICINES SCHEDULES • There are now SIX schedules instead of NINE: • SCHEDULE 0 • SCHEDULE 1 • SCHEDULE 2 • SCHEDULE 3 • SCHEDULE 4 • SCHEDULE 5

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

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

10. MAIN CHANGES (6) • EXPEDITED REGISTRAION PROCESS: • ESSENTIAL MEDICINES LIST • PUBLIC HEALTH JUSTIFICATION • 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

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

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

14. I THANK YOU