Namibia Government Gazette dated 2011-07-26 number 4761

GOVERNMENT GAZETTE
OF THE

REPUBLIC OF NAMIBIA
N$4.00

WINDHOEK - 26 July 2011

No. 4761

CONTENTS

Page

GOVERNMENT NOTICE
No. 122

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

1

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Government Notice
MINISTRY OF HEALTH AND SOCIAL SERVICES
No. 122

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 Schedule 1 and 2 have been registered in terms of
that Act, subject to the following conditions (a)

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

(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 subsection (7) of section 19
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;