Act No. 13, 2003
MEDICINES AND RELATED SUBSTANCES
CONTROL ACT, 2003
ACT
To
provide for the establishment of a Namibia Medicines Regulatory Council;
for the registration of medicines intended for human and for animal use; for
the control of medicines and scheduled substances; and to provide for
incidental matters.
(Signed by the President on 13 August 2003)
ARRANGEMENT OF SECTIONS
Section
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35.
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42.
Definitions
Continuation of Council, and its powers and functions
Constitution of Council
Disqualification for appointment as member of Council
Tenure of office of members
Vacation of office and filling of vacancies
Chairperson and vice- chairperson
Meetings of Council
Disclosure of interest
Remuneration
Executive committee
Veterinary medicines committee
Other committees
Restriction of liability
Financial year and annual report
Appointment of Registrar of Medicines
Registers
Prohibition on sale of medicines, which are subject to registration and are not
registered
Registration of medicines
Amendment of entries in register
Transfer of certificate of registration
Cancellation of registration
Notification of registration, or cancellation of registration, in the Gazette
Labels and advertisements
Prohibition on sale of medicines, which do not comply with prescribed
requirements, and furnishing of information regarding medicines to the Council
Publication or distribution of false advertisements concerning medicines
Council may authorise sale of unregistered medicines for certain purposes
Council to cause certain information to be furnished
Control of medicines and scheduled substances
Generic substitution
Licences and permits
Publication of information relating to medicines, scheduled substances or other
things subject to this Act
Disposal of undesirable medicines
Appeal against decisions of Council
Inspectors
Powers of inspectors
Analysts
Offences
Penalties
Presumptions and evidence
Special defences in case of prosecutions
Preservation of secrecy and inappropriate use of information