THE MINISTRY OF HEALTH
Official Dispatch No. 302/BYT-QLD dated January 22, 2014 of the Ministry of Health on drug manufacturers, drug importers, and applicants for drug registration
On August 31, 2012, the Ministry of Health issued the Circular No. 14/2012/TT-BYT on principles, standards, and application of Good manufacturing practice (GMP) for pharmaceutical packaging. Article 9 Clause 5 says:
“a) From April 01, 2013, the facilities that produce drugs circulating on the market may only use the primary packages (level 1) that are uncleanable before use such as rolled packages (aluminum foil or PVC foil) and syringes provided by facilities that complies with GMP of pharmaceutical packaging...
“b) From April 01, 2013, the facilities that produce drugs circulating on the market may only use other kinds of primary packages provided by the facilities comply with GMP of pharmaceutical packaging. The batches of packages must be enclosed with certificates of testing, original stamps and labels of manufacturers".
Instructions on the implementation of the Circular No. 14/2012/TT-BYT:
1. General principles:
a) All packages in physical contact with drugs circulated in Vietnam must undergo quality inspection and meet quality standards before being used for manufacture of finished drugs, and must be safe for users.
b) The quality standards applied to packages in physical contact with drugs must include the criteria for package materials and be conformable with Vietnam’s pharmacopoeia as well as other common pharmacopoeias such as England’s, USA’s, Japan’s, Europe’s, or International pharmacopoeia.
c) Packages in physical contact with drugs must be manufactured at the facilities comply with GMP
2. Clause 5 Article 9 of the Circular No. 14/2012/TT-BYT is interpreted as follows:
