Search results
Updates in line with ASEAN Variation Guideline for Pharmaceutical Products (Revision 1 & 2) and inclusion of country specific variation types & requirements as follows:
Oct 13, 2021 · Posted By Ng Pei Ling. Variation application for pharmaceutical products shall be done according to the Malaysian Variation Guideline (MVG). For unregulated drug substances, kindly note that only the following sections are required and will depend on the type of variation being applied.
Aug 12, 2022 · This Malaysian Variation Guideline concerns the variation applications submitted by the PRH for pharmaceutical products for human use only. It is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a pharmaceutical product.
This ASEAN Variation Guideline concerns the variation applications submitted by the marketing authorization holder for pharmaceutical products for human use only and not including biologics.
The NPRA Malaysia has updated its variation guideline for pharmaceutical products in July 2022, based on the ASEAN and country-specific requirements. The guideline covers 17 variation types, timelines, and submission options for applications.
Jul 20, 2022 · Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its variation guideline for pharmaceutical products, reflecting revisions to the Association of Southeast Asian Nations’ (ASEAN) position on the topic. NPRA published the first version of the guideline in 2013.
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has updated its variation guideline for pharmaceutical products to be in line with recent revisions to Association of Southeast Asian Nations’ (ASEAN).
