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6 October 2020

Namibia Government Gazette dated 2020-10-06 number 7353

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                      GOVERNMENT GAZETTE
                                                                            OF THE

                           REPUBLIC OF NAMIBIA
N$6.00                                                  WINDHOEK - 6 October 2020                                                                                   No. 7353

                                                                           CONTENTS
                                                                                                                                                                            Page
GOVERNMENT NOTICE

No. 248     Notification of registration of certain medicines: Medicines and Related Substances Control Act,
            2003 ........................................................................................................................................................      1
                                                                    ________________


                                                      Government Notice
                                MINISTRY OF HEALTH AND SOCIAL SERVICES

No. 248                                                                                                                                                                     2020

                  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 medicines set out in the Schedule have been registered in terms of that Act,
subject to the following conditions:

(a)       the applicant must ensure that the medicine is manufactured and controlled in terms of
          the existing current good manufacturing practices as determined by the World Health
          Organisation;

(b)       inspections and investigations may be carried out regularly by inspectors authorised in terms
          of sections 35 of the Act, to assess compliance with existing current good manufacturing
          practices;

(c)       the applicant must, subject to the approval of Namibia Medicines Regulatory Council
          (hereafter referred to as “the Council”), ensure that the information contained in the medicine
          package insert is regularly updated so as to provide accurate information to the user of the
          medicine;

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