ASEAN Common Technical Requirements

Subtitle :

Abstract :
This guidance document is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a pharmaceutical product. Variation applications are categorized into major variation, minor variation (prior approval) and minor variation (notification). Updating of this guideline will be done on a periodic basis as required.

Registration No : B2240
Author :
ASEAN Secretariat

Edition :
Impresum : Jakarta: ASEAN Secretariat, 2016
Description :
Language : English

ISBN 978-602-6392-26-8

Classification:
1. 200 - ECONOMIC COMMUNITY / 210.5 - TRADE AND FACILITATION - Standards and Conformance

Keyword :
1 ACTR


Availability :
Hard copies 3 of 3

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