new namibia medicines control act sapraa meeting 5 september 2008 presented by: johannes gaeseb...
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NEW NAMIBIA NEW NAMIBIA MEDICINES CONTROL MEDICINES CONTROL
ACT ACT
SAPRAA meetingSAPRAA meeting5 September 20085 September 2008
Presented by:Presented by:Johannes GaesebJohannes Gaeseb
Registrar of Medicines Registrar of Medicines NAMIBIANAMIBIA
BACKGROUNDBACKGROUND
Before independence all RSA laws were Before independence all RSA laws were applicable in Namibiaapplicable in Namibia
All medicines regulated in RSA, All medicines regulated in RSA, applicable automatically in Namibiaapplicable automatically in Namibia
After independence, March 1990, only After independence, March 1990, only the medicines regulatory laws as the medicines regulatory laws as amended in 1977 applicable in Namibiaamended in 1977 applicable in Namibia
Namibia to amend Act 101 of 1965 to Namibia to amend Act 101 of 1965 to take over the medicines registered take over the medicines registered before 1990before 1990
BACKGROUNDBACKGROUND
There was a need to update the There was a need to update the medicines control legislation:medicines control legislation: Act 101 of 1965 was outdatedAct 101 of 1965 was outdated New developments in the New developments in the
pharmaceutical sector, i.e. pharmaceutical sector, i.e. counterfeiting, TRIPScounterfeiting, TRIPS
National Drug Policy of 1998 National Drug Policy of 1998
LEGISLATIONLEGISLATION MEDICINES AND RELATED MEDICINES AND RELATED
SUBSTANCES CONTROL ACT,2003 SUBSTANCES CONTROL ACT,2003 (ACT 13 OF 2003)(ACT 13 OF 2003)
MEDICINES CONTROL AMENDMENT MEDICINES CONTROL AMENDMENT ACT, 2007 (ACT 8 OF 2007)ACT, 2007 (ACT 8 OF 2007)
ACCOMPANYING REGULATIONS & ACCOMPANYING REGULATIONS & MEDICINES SCHEDULESMEDICINES SCHEDULES
MAIN CHANGES (1)MAIN CHANGES (1)
Name change of the regulatory body Name change of the regulatory body from Medicines Control Council (MCC) from Medicines Control Council (MCC) to Namibia Medicines Regulatory to Namibia Medicines Regulatory Council (NMRC)Council (NMRC)
Registration of Veterinary medicinesRegistration of Veterinary medicines Registration of Complementary Registration of Complementary
medicinesmedicines Labeling requirements for medicines Labeling requirements for medicines
on the Namibian marketon the Namibian market
MAIN CHANGES (2)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 NMRCRegistration number given by NMRC Namibian scheduling statusNamibian scheduling status Both manufacturing and expiry dates must Both manufacturing and expiry dates must
be on labelbe on label
PATIENT INFORMATION LEAFLET PATIENT INFORMATION LEAFLET
MAIN CHANGES (3)MAIN CHANGES (3)
MEDICINES SCHEDULESMEDICINES SCHEDULES
There are now SIX schedules instead There are now SIX schedules instead of NINE:of NINE: SCHEDULE SCHEDULE 00 SCHEDULESCHEDULE 11 SCHEDULESCHEDULE 22 SCHEDULESCHEDULE 33 SCHEDULESCHEDULE 44 SCHEDULESCHEDULE 55
MAIN CHANGES (4)MAIN CHANGES (4)
MANUFACTURERS TO REGISTER MANUFACTURERS TO REGISTER WITH NMRCWITH NMRC
IMPORTERS & EXPORTERS MUST IMPORTERS & EXPORTERS MUST HAVE LICENCEHAVE LICENCE
DISPENSING MEDICAL DISPENSING MEDICAL PRACTITIONERS TO HAVE A LICENCEPRACTITIONERS TO HAVE A LICENCE
MAIN CHANGES (5)MAIN CHANGES (5) PERSONS WHO MAY APPLY FOR PERSONS WHO MAY APPLY FOR
REGISTRATION OF A MEDICINEREGISTRATION OF A MEDICINE A PERSON RESIDING AND DOING BUSINESS IN A PERSON RESIDING AND DOING BUSINESS IN
NAMIBIANAMIBIA A FOREIGN MANUFACTURER OF A MEDICINEA FOREIGN MANUFACTURER OF A MEDICINE A FOREIGN MANUFACTURER’S NOMINEE A FOREIGN MANUFACTURER’S NOMINEE
RESIDING IN NAMIBIARESIDING IN NAMIBIA A SUBSIDIARY OF A FOREIGN MANUFACTURERA SUBSIDIARY OF A FOREIGN MANUFACTURER HOLDER OF A PERMIT SECTION 31(4) OF THE HOLDER OF A PERMIT SECTION 31(4) OF THE
ACTACT ALL THOSE NOT RESIDING IN NAMIBIA ALL THOSE NOT RESIDING IN NAMIBIA
MUST APPOINT A REPRESENTATIVE BASED MUST APPOINT A REPRESENTATIVE BASED IN NAMIBIAIN NAMIBIA
MAIN CHANGES (6)MAIN CHANGES (6)
EXPEDITED REGISTRAION PROCESS:EXPEDITED REGISTRAION PROCESS: ESSENTIAL MEDICINES LISTESSENTIAL MEDICINES LIST PUBLIC HEALTH JUSTIFICATIONPUBLIC HEALTH JUSTIFICATION MEDICINES TENDERED MEDICINES TENDERED
INTERNATIONALLY BY THE STATE FOR INTERNATIONALLY BY THE STATE FOR SUPPLY TO STATE HEALTH FACILITIESSUPPLY TO STATE HEALTH FACILITIES
MAIN CHANGES (7)MAIN CHANGES (7)
ADVERTISEMENTSADVERTISEMENTS
Advertisements of medicines to the Advertisements of medicines to the public must be approved by NMRC public must be approved by NMRC
MAIN CHANGES (5)MAIN CHANGES (5)
FEESFEES APPLICATION FEEAPPLICATION FEE INSPECTION FEEINSPECTION FEE REVISED REGISTRATION AND REVISED REGISTRATION AND
RETENTION FEESRETENTION FEES
CONTACT DETAILSCONTACT DETAILS
WEBSITE: WEBSITE: www.nmrc.com.nawww.nmrc.com.na E-mail: E-mail: [email protected]@nmrc.com.na / /
[email protected]@cms-namibia.com Tel: +264 61 203 2400/03Tel: +264 61 203 2400/03 Fax: +264 61 225 048Fax: +264 61 225 048 Postal Address: Postal Address: Private Bag 13366, Private Bag 13366,
WindhoekWindhoekNamibiaNamibia
I THANK YOUI THANK YOU