Decision No. 27/2007/QD-BYT on the implementation schedule for applying the "Good Manufacturing Practice" principles and standards and the "Good Storage Practice" principles for drugs.

Pursuant to …;

Regarding the issuance of the roadmap for implementing the principles and standards

"Good Manufacturing Practice" (GMP) and the principle "Good Storage Practice" (GSP)

____________________________

||| MINISTER OF HEALTH

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Quality Goods Ordinance dated December 12, 1999;

Pursuant to the Government Decree No. 179/2004/NĐ-CP dated October 21, 2004 on quality goods management;

Pursuant to the Government Decree No. 49/2003/NĐ-CP dated May 15, 2003 on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Government Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Drug Law;

Pursuant to Decision No. 108/2002/QĐ-TTg dated February 15, 2002 of the Prime Minister approving the "Strategic Development Plan for the Pharmaceutical Industry until 2010";

Considering the actual situation of implementing the principles and standards "Good Manufacturing Practice" (GMP) and the principle "Good Storage Practice" (GSP) at production, trading, storage, and preservation facilities;

Considering the proposal of the Director of the Vietnam Drug Administration,

DECISION:

Article 1. This Decision hereby promulgates the roadmap for implementing the principles and standards "Good Manufacturing Practice" (GMP) and the principle "Good Storage Practice" (GSP), as follows:

1. Implementation plan for the principles and standards "Good Manufacturing Practice" (GMP).

a) Encourage facilities to implement the principles and standards "Good Manufacturing Practice" (GMP) according to the World Health Organization's recommendations (GMP-WHO).

b) New pharmaceutical manufacturing facilities must meet the principles and standards "Good Manufacturing Practice" of the Association of Southeast Asian Nations (GMP-ASEAN) or "Good Manufacturing Practice" according to the World Health Organization's recommendations (GMP-WHO).

c) Facilities producing injectable drugs, intravenous drugs, and antibiotics containing beta-lactam groups must meet the principles and standards GMP-ASEAN or GMP-WHO to be allowed to produce.

d) Existing pharmaceutical manufacturing facilities that have been permitted to produce but do not meet the principles and standards GMP-ASEAN or GMP-WHO but comply with the provisions set out in Appendix 1 attached to this Decision may continue to produce until June 30, 2008.

đ) As of July 1, 2008, existing pharmaceutical manufacturing facilities that have been permitted to produce must meet the principles and standards GMP-WHO.

e) Facilities currently implementing the principles and standards GMP-ASEAN will only be granted certificates valid until June 30, 2008.

g) Facilities producing topical medications listed in the Appendix 1 of the Drug Registration Regulation issued by Decision No. 3121/2001/QĐ-BYT dated July 18, 2001 of the Minister of Health may produce until the end of 2010. As of January 1, 2011, these facilities must meet the principles and standards GMP-WHO.

h) As of January 1, 2011, all facilities producing drugs from medicinal herbs must meet the principles and standards GMP-WHO.

2. Implementation plan for the principle "Good Storage Practice" (GSP).

a) Encourage trading, storage, and preservation facilities, hospital pharmacy departments, research institutes, and health centers to implement the principle "Good Storage Practice".

b) Trading facilities already operating or directly importing/exporting medicines for human disease prevention and treatment that do not meet the principle "Good Storage Practice" but comply with the conditions specified in Appendix 2 attached to this Decision may continue direct import/export operations until June 30, 2008.

c) As of July 1, 2008, all trading facilities already operating or directly importing/exporting medicines for human disease prevention and treatment must have drug storage warehouses meeting the GSP standard to continue direct import/export operations.

d) From the date this Decision takes effect, facilities applying for the function of directly importing/exporting drugs (both raw materials and finished products) must have drug warehouses meeting the GSP standard.

đ) As of January 1, 2011, all trading, storage, and preservation facilities, hospital pharmacy departments, research institutes, and health centers must implement the GSP principle.

e) Facilities providing drug storage services must meet the GSP principle and be recognized by the Ministry of Health as qualified businesses to provide drug storage services to be allowed to operate.

Article 2. This Decision shall take effect 15 days after its publication in the Official Gazette and shall replace Decision No. 19/2005/QĐ-BYT dated July 5, 2005 of the Minister of Health on adjusting the implementation plan for the principles and standards "Good Manufacturing Practice" (GMP) issued by Decision No. 3886/2004/QĐ-BYT dated November 3, 2004 of the Minister of Health on implementing the principles and standards "Good Manufacturing Practice" (GMP) according to the World Health Organization's recommendations and "Good Storage Practice" issued by Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on implementing the principle "Good Storage Practice".

Article 3. The Director of the Vietnam Drug Administration is responsible for organizing the implementation of the principles and standards "Good Manufacturing Practice" (GMP) and the principle "Good Storage Practice" (GSP) in accordance with the planned schedule.

Article 4. The Heads of the Ministry of Health's Office, Inspectorate, Director of the Vietnam Drug Administration, Heads of subordinate units under the Ministry, Directors of Provincial Health Departments, Central City Health Departments, and Health Services are responsible for enforcing this Decision.