Transcription of Edition Draft - Medsafe
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Guideline on the Regulation of Therapeutic Products in New Zealand Part 4: Manufacture of medicines Edition Draft October 2014 Part 4, Ed Draft Page 2 of 9 Section 1: good manufacturing Practice Documentation When is GMP Documentation Required? Medsafe requires evidence of good manufacturing Practice (GMP) compliance for each finished product manufacturing site and packaging site specified in a New Medicine Application or Changed Medicine Notification. Evidence of GMP compliance is required for products regarded as medicines in New Zealand, whether or not they are considered medicines in the country of origin.
Part 4, Ed Draft Page 2 of 9 Section 1: Good Manufacturing Practice Documentation 1.1. When is GMP Documentation Required? Medsafe requires evidence of Good Manufacturing Practice (GMP) compliance for
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