Namibia Government Gazette dated 2011-10-17 number 4812

GOVERNMENT GAZETTE
OF THE

REPUBLIC OF NAMIBIA
N$4.00

WINDHOEK - 17 October 2011

No. 4812

CONTENTS

Page

GOVERNMENT NOTICE
No. 197

Registration of certain medicines: Medicines and Related Substances Control Act, 2003 . ..................
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1

Government Notice
MINISTRY OF HEALTH AND SOCIAL SERVICES
No. 197

2011
REGISTRATION OF CERTAIN MEDICINES: MEDICINES AND RELATED
SUBSTANCES CONTROL ACT, 2003

In terms of section 23 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of
2003), I give notice that the medicines set out in the attached schedule have been registered in terms
of that Act, subject to the following conditions:
1.

The manufacture and control of the medicines must be in accordance with the existing
current Good Manufacturing Practices as required by the World Health Organization;

2.

In order to assess compliance with paragraph (1), inspections and investigations may be
carried out regularly by inspectors authorized in terms of sections 35 of the Act;

3.

The information in the package insert must, on a regular basis, be updated to conform with
the package insert approved by the Council;

4.

The holder of the certificate of registration which is referred to in section 19(7) of the Act,
must comply with the Act;

5.

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 registration of the medicine;