ANALYSIS AND IMPLEMENTATION APPROACHES: EVOLUTION OF VIETNAM’S REGULATIONS FOR LABELLING OF DRUG AND PHARMACEUTICAL PACKAGING GMP

Abstract

To enhance drug quality, labelling transparency, and compliance with ASEAN standards, Vietnam has been continuously refining its regulatory framework under the guidance of its Ministry of Health (MOH). Circular 06/2016/TT-BYT in 2016 introduced many important changes to Vietnam drug labelling requirements, and Circular 02/2016/TT-BYT supplemented GMP standards on the packaging of medicinal products. We have reviewed these added regulatory requirements and how they differ from the existing 2008 guidelines. The study also provides execution methods to ensure easy compliance for local and foreign manufacturers, especially Indian exporters that account for a large share of pharmaceutical imports in Vietnam.