Transcription of Guideline on the - Medsafe Home Page
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Guideline on the - Medsafe Home Page
Guideline on the Regulation of Therapeutic Products in New Zealand Part 2: Obtaining approval for new and changed medicines and related products Edition March 2016 Contents Section 1: Introduction .. 5 The New Zealand Medicines Act 1981 .. 5 Other information relevant to this Guideline .. 5 Overview of the approval of new and changed medicines .. 5 Section 2: Who can submit an application .. 7 Sponsor obligations .. 8 Section 3: New medicine application types .. 10 When is a medicine a new medicine ? .. 10 Evidence that a medicine has been generally available .. 10 Previously approved medicine that has not been generally available .. 10 Combination packs of currently approved medicines .. 11 New Medicine Applications.
Guideline on the Regulation of Therapeutic Products in New Zealand Part 2 : Obtaining approval for new and changed medicine s and related products
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