Namibia Government Gazette dated 2019-05-21 number 6910

GOVERNMENT GAZETTE
OF THE

REPUBLIC OF NAMIBIA
N$6.00 WINDHOEK - 21 May 2019 No. 6910

CONTENTS
Page
GOVERNMENT NOTICES

No. 127 Notification of registration of certain medicines: Medicines and Related Substances Control Act, 2003 . 1

No. 128 Notification of registration of certain medicines: Medicines and Related Substances Control Act, 2003.. 7
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Government Notices
MINISTRY OF HEALTH AND SOCIAL SERVICES

No. 127 2019

NOTIFICATION OF 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 Schedule have been registered 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 Organisation;

(b) in order to assess compliance with paragraph (a), an inspection or investigation may be
carried out regularly by an inspector authorised in terms of sections 35 of the Medicines and
Related Substances Control Act, 2003;

(c) the information contained in the medicine package insert must, on a regular basis, be updated
to conform with the package insert approved by the Namibia Medicines Regulatory Council
so as to provide accurate information to the user of the medicines;