Namibia Government Gazette dated 2011-06-03 number 4726

GOVERNMENT GAZETTE
OF THE

REPUBLIC OF NAMIBIA
N$2.00

WINDHOEK - 3 June 2011

No. 4726

CONTENTS

Page

GOVERNMENT NOTICE
No. 71

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

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Government Notice
MINISTRY OF HEALTH AND SOCIAL SERVICES
No. 71

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

In terms of section 23 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of
2003) (hereinafter referred to as “the Act”), I give notice that the medicines set out in the attached
schedule have been registration in terms of that Act, subject to the following conditions (a)

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;

(b)

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

(c)

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

(d)

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

(e)

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;