Transcription of MEDICINES CONTROL COUNCIL - mccza.com
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MEDICINES CONTROL COUNCIL - mccza.com
Registration of MEDICINES Pharmaceutical & Analytical PA Jun11 v6 showing June 2011 Page 1 of 27 MEDICINES CONTROL COUNCIL PHARMACEUTICAL AND ANALYTICAL This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of MEDICINES . 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. Alternative approaches may be used but these should be scientifically and technically justified.
Registration of Medicines Pharmaceutical & Analytical 2.02 PA Jun11 v6 showing changes.doc Page June 2011 1 of 27 MEDICINES CONTROL COUNCIL PHARMACEUTICAL AND ANALYTICAL
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