Namibia Government Gazette dated 2008-08-18 number 4103
GOVERNMENT GAZETTE
OF THE
REPUBLIC OF NAMIBIA
N$2.40
WINDHOEK - 18 August 2008
No. 4103
CONTENTS
GOVERNMENT NOTICES
No. 196
Medicines and Related Substances Control Act, 1965: Registration of certain medicines .........
1
No. 197
Regulations relating to scope of practice of oral hygiene: Medical and Dental Act, 2004 ..........
10
No. 198
Regulations relating to ownership of pharmacy by private hospital: Pharmacy Act, 2004 .........
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11
Government Notices
MINISTRY OF HEALTH AND SOCIAL SERVICES
No. 196
2008
MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 1965:
REGISTRATION OF CERTAIN MEDICINES
In terms of section 17(a) of the Medicines and Related Substances Control Act, 1965 (Act No. 101 of
1965), I give notice that the medicines set out in the Schedule are registered subject to the following
conditions:
(a)
the manufacture and control of the medicine must be in accordance with the existing
good manufacturing practices as required by the World Health Organization;
(b)
in order to assess compliance with paragraph (a), inspections and investigations may
be carried out, at such times as the council may consider necessary, by inspectors
authorized in terms of section 26 of the Act to do so;
(c)
the information contained in the package insert must, by the manufacturer of the
medicine concerned, be updated so as to conform with the package insert approved
by the Medical Control Council so as to ensure that such insert provides accurate
information to the user of the medication concerned;
(d)
the registration of medicine is subject to regular review regarding its quality, safety
and efficacy, and the Council may, as it considers necessary, vary the conditions of
registration of the medicine;