DECISION

ON THE APPLICATION OF GOOD MANUFACTURING PRACTICE PRINCIPLES AND STANDARDS, GOOD LABORATORY PRACTICE PRINCIPLES, GOOD STORAGE PRACTICE PRINCIPLES AND GOOD DISTRIBUTION PRACTICE PRINCIPLES TO ESTABLISHMENTS THAT MANUFACTURE, TEST, TRADE IN, DISTRIBUTE, IMPORT, EXPORT, STOCKPILE AND STORE VACCINES AND MEDICAL BIOLOGICALS

THE MINISTER OF HEALTH

Pursuant to the Governments Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the June 14, 2005 Pharmacy Law;

Pursuant to the December 24, 1999 Ordinance on Goods Quality;

Pursuant to the Governments Decree No. 179/2004/ND-CP of October 21, 2004, providing for goods quality management;

Pursuant to the Governments Decree No. 79/2006/ND-CP of August 9, 2006, detailing the implementation of a number of articles of the Pharmacy Law;

Pursuant to the Prime Ministers Decision No. 108/2002/QD-TTg of August 15, 2002, approving the pharmacy development strategy up to 2010;

Pursuant to the Prime Ministers Decision No. 255/2006/QD-TTg of November 9, 2006, approving the national strategy on Vietnams preventive medicine up to 2010 and orientations to 2020;

At the proposal of the director of the Vietnam Drug Administration,

DECIDES:

Article 1. To promulgate the Health Ministrys regulations on the application of Good Manufacturing Practice principles and standards recommended by the World Health Organization, Good Laboratory Practice principles, Good Storage Practice principles and Good Distribution Practice principles to establishments that manufacture, test, wholesale, import, export, stockpile and store vaccines and medical biologicals in Vietnam as follows:

1. Regulations on the application of Good Manufacturing Practice principles and standards:

a/ Vaccine- and medical biologicals-manufacturing enterprises shall implement the Health Ministers Decision No. 3886/2004/QD-BYT of November 3, 2004, on the application of Good Manufacturing Practice principles and standards recommended by the World Health Organization (below referred to as GMP-WHO principles and standards).

b/ From January 1, 2011, vaccine- and medical biologicals-manufacturing enterprises must satisfy GMP-WHO principles and standards.

c/ Vaccine- and medical biologicals-manufacturing enterprises set up after the effective date of this Decision must satisfy GMP-WHO principles and standards in order to be granted certificates of eligibility for manufacturing vaccines and medical biologicals.

d/ Enterprises currently licensed to manufacture vaccines and medical biologicals must, when establishing or adding new production chains, satisfy GMP-WHO principles and standards applicable to those chains in order to be licensed to manufacture vaccines and medical biologicals.

e/ Enterprises currently licensed to manufacture vaccines and medical biologicals may continue manufacturing them till the end of December 31, 2010. From January 1, 2011, these enterprises must satisfy GMP-WHO principles and standards in order to be granted extended certificates of eligibility for manufacturing vaccines and medical biologicals.

2. Regulations on the application of Good Laboratory Practice principles:

a/ Vaccine and medical biologicals laboratories (including state laboratories and enterprises providing the laboratory service) shall implement the Health Ministers Decision No. 1570/2000/QD-BYT of May 22, 2000, on the application of Good Laboratory Practice principles (below referred to as GLP principles).

b/ From January 1, 2011, all vaccine and medical biologicals laboratories must satisfy GLP principles.

c/ Newly set up state vaccine and medical biologicals laboratories must satisfy GLP principles in order to be licensed to operate.

d/ Enterprises that provide the laboratory service for vaccines and medical biologicals which are set up after the effective date of this Decision must satisfy GLP principles in order to be granted certificates of eligibility for providing the laboratory service for vaccines and medical biologicals.

e/ The National Institute for Expertise of Vaccines and Medical Biologicals must be upgraded up to international standards and GLP principles in accordance with the Prime Ministers Decision No. 154/2006/QD-TTg of June 30, 2006, approving the scheme on state management of pharmaceuticals and food and cosmetics safety and hygiene during 2006-2015.

3. Regulations on the application of Good Distribution Practice principles:

Establishments that manufacture, wholesale, distribute, store and stockpile vaccines and medical biologicals (including hospitals pharmacy wards, research institutes and preventive medicine centers) shall, depending on their functions and operation scopes, implement some or all of the provisions of the Health Ministers Decision No. 12/2007/QD-BYT of January 24, 2007, on the application of Good Distribution Practice principles (below referred to as GDP principles), and the provisions of Article 2 of Decision No. 29/2007/QD-BYT of May 11, 2007, supplementing a number of contents of Good Pharmacy Practice principles and standards promulgated together with the Health Ministers Decision No. 11/2007/QD-BYT of January 24, 2007, and Good Distribution Practice principles promulgated together with the Health Ministers Decision No. 12/2007/QD-BYT of January 24, 2007.

4. Regulations on the application of Good Storage Practice principles:

a/ From the effective date of this Decision, enterprises that provide the service of storing vaccines and medical biologicals must have storehouses satisfying Good Storage Practice principles promulgated together with the Health Ministers Decision No. 2701/2001/QD-BYT of June 29, 2001, on the application of Good Storage Practice principles (below referred to as GSP principles) in order to be granted by the Ministry of Health certificates of eligibility for providing the service of storing vaccines and medical biologicals.

b/ From the effective date of this Decision, vaccine and medical biologicals-wholesaling enterprises must satisfy GDP principles and have storehouses satisfying GSP principles in order to additionally be licensed to directly import and export vaccines and medical biologicals.

c/ From July 1, 2008, enterprises that directly import and export vaccines and medical biologicals must satisfy GDP principles and have storehouses satisfying GSP principles in order to be licensed to continue these activities.

5. Establishments that manufacture, test, wholesale, distribute, import, export, stockpile and store medical biologicals used in diagnosis are encouraged to apply GMP-WHO, GLP, GSP and GDP principles and standards suitable to each type of their business activities.

Article 2. This Decision takes effect 15 days after its publication in CONG BAO. To annul the Health Ministers Decision No. 5405/2002/QD-BYT of December 31, 2002, promulgating Good Manufacturing Practice guidance applicable to Vietnamese vaccines and medical biologicals, and the Health Ministrys Circular No. 19/2005/TT-BYT of July 19, 2005, guiding the order of, procedures and competence for granting certificates of satisfaction of Good Manufacturing Practice standards applicable to vaccines and medical biologicals.

Article 3. The director of the Vietnam Drug Administration shall guide the implementation of Article 1 of this Decision.

Article 4. The director of the Office and the chief inspector of the Ministry of Health, the director of the Vietnam Drug Administration, the director of the Vietnam Preventive Medicine Department, the director of the Therapy Department, heads of units attached to the Ministry, directors of provincial/ municipal Health Services, and heads of healthcare sections of branches shall implement this Decision.