Act No. 13, 2003
MEDICINES AND RELATED SUBSTANCES
CONTROL ACT, 2003
“vice-chairperson” means the person elected as vice-chairperson of the Council in terms
of section 7(1).
(2) Notwithstanding anything contained in any other law, a medicine must be
regarded as being the same as any other medicine registered in Namibia, if
(a)
its components, physical characteristics, quantity and quality are identical
to those of that other medicine;
(b)
it is manufactured by the same manufacturer; and
(c)
the label and the information accompanying that medicine is approved by
the Council.
(3) In determining whether or not the registration or availability of a medicine
is in the public interest, regard must be had to its safety, quality and therapeutic efficacy
in relation to its effect on the health of humans or animals, as the case may be.
(4) In the registration of medicines, the registration of essential drugs must
receive priority.
Continuation of Council, and its powers and functions
2.
(1) The council known as the Medicines Control Council established by
the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), continues
to exist under the name Namibia Medicines Regulatory Council.
(2) The Council may exercise the powers conferred, and must perform the
functions assigned, to the Council by or under this Act.
(3) Without prejudice to the generality of subsection (2), the functions of the
Council are to
(a)
advise the Minister and report to the Minister on any matter referred to the
Council by the Minister for consideration and arising from the application
of this Act; and
(b)
register medicines and any other thing that is required or prescribed to be
registered.
Constitution of Council
3.
(1) The Council consists of the following members appointed by the
Minister as follows:
(a)
Three medical practitioners
(i)
one of whom is registered as a medical specialist;
(ii)
one of whom is engaged in private medical practice; and
(iii) one of whom is employed by the Ministry responsible for health;
(b)
three pharmacists
(i)
one of whom is engaged in private pharmaceutical practice;
(ii)
one of whom is employed by the Ministry responsible for health; and