THE MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 14/2012/TT-BYT
Hanoi , August 31, 2012
 
CIRCULAR
ON THE PRINCIPLES AND STANDARDS OF “GOOD MANUFACTURING PRACTICE OF PHARMACEUTICAL PACKAGING”, AND GUIDING ITS APPLICATION
Pursuant to the Law on Pharmaceuticals No. 34/2005/QH11 dated June 14, 2005;
Pursuant to the Government's Decree No. 188/2007/NĐ-CP dated December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Prime Minister’s Decision No. 43/2007/QĐ-TTg dated March 29, 2007, approving the Scheme “Developing the pharmaceuticals industry and the medicine dispensary system of Vietnam during 2007 – 2015 and towards 2020”;
At the proposal of the Director of the Drug administration of Vietnam,
The Ministry of Health promulgates the Circular on the principles and standards of “Good manufacturing practice of pharmaceutical packaging”, and guides the application as follows:
Section I
GENERAL PROVISIONS
Article 1. Scope of regulation
This Circular provides for the principles and standards of “Good manufacturing practice of pharmaceutical packaging”, and guides the application of such principles and standards to the production of packages that directly contact the medicines.
Article 2. Subjects of application
This Circular is applicable to the facilities producing and trading packages in physical contact with drugs, and the facilities producing medicines that circulate on the Vietnam’s market.
Section II
PRINCIPLES AND STANDARDS OF “GOOD MANUFACTURING PRACTICE OF PHARMACEUTICAL PACKAGING”, AND GUIDES TO APPLICATION
Article 3. Principles and standards of “Good manufacturing practice of pharmaceutical packaging”
The principles and standards of “Good manufacturing practice of pharmaceutical packaging” are specified in Annex 1 and Annex 2 enclosed with this Circular.
Article 4. Implementation organization
1. The Drug administration of Vietnam shall be in charge and cooperate with relevant units to disseminate the principles and standards of “Good manufacturing practice of pharmaceutical packaging” (hereinafter referred to as GMP of pharmaceutical packaging), the list of GMP of pharmaceutical packaging inspection, and guide the application of GMP of pharmaceutical packaging for the Services of Health of central-affiliated cities and provinces, the Health agencies and facilities that produce packages in physical contact with drugs.
2. Facilities producing packages in physical contact with drugs wishing to apply for inspection in order to be issued with the GMP Certificate of pharmaceutical packaging: