Transcription of MEDICINES CONTROL COUNCIL - mccza.com
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MEDICINES CONTROL COUNCIL - mccza.com
Registration of MEDICINES Amendments August 2012 Page 1 of 43 MEDICINES CONTROL COUNCIL AMENDMENTS This guideline has been prepared to serve as a recommendation to the holder of a certificate of registration wishing to submit applications for amendment of a registration dossier of a medicine . It represents the MEDICINES CONTROL COUNCIL s current thinking on the safety, quality and efficacy of MEDICINES . It is not intended as an exclusive approach. COUNCIL reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine in keeping with the knowledge current at the time of evaluation.
Registration of Medicines Amendments 2.08_Amendments_Jul12_v6 August 2012 Page 4 of 43 Return to ToC 2 Amendment Submissions: Format continued 2.3 An amendment application may not address more than one product unless
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