NEW NAMIBIA MEDICINES CONTROL ACT

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NEW NAMIBIA MEDICINES CONTROL ACT

• SAPRAA meeting
• 5 September 2008
• Presented by
• Johannes Gaeseb
• Registrar of Medicines
• NAMIBIA

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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

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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• Act 101 of 1965 was outdated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

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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

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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

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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

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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

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MAIN CHANGES (4)

• MANUFACTURERS TO REGISTER WITH NMRC
• IMPORTERS EXPORTERS MUST HAVE LICENCE
• DISPENSING MEDICAL PRACTITIONERS TO HAVE A LICENCE

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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 MANUFACTURERS 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

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MAIN CHANGES (6)

• EXPEDITED REGISTRAION PROCESS
• ESSENTIAL MEDICINES LIST
• PUBLIC HEALTH JUSTIFICATION
• MEDICINES TENDERED INTERNATIONALLY BY THE STATE
  FOR SUPPLY TO STATE HEALTH FACILITIES

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MAIN CHANGES (7)

• ADVERTISEMENTS
• Advertisements of medicines to the public must be
  approved by NMRC

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MAIN CHANGES (5)

• FEES
• APPLICATION FEE
• INSPECTION FEE
• REVISED REGISTRATION AND RETENTION FEES

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CONTACT DETAILS

• WEBSITE www.nmrc.com.na
• E-mail regmeds_at_nmrc.com.na / regmeds_at_cms-nami
  bia.com
• Tel [phone]
• Fax [phone]
• Postal Address Private Bag 13366, Windhoek
• Namibia

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• I THANK YOU