Decision No. 19/2005/QĐ-BYT of the Minister of Health adjusts the plan to implement the principles and standards of 'Good Manufacturing Practice for Medicines' and 'Good Storage Practice for Medicines' at pharmaceutical production, trading, storage, and preservation facilities in Vietnam. This Decision shall take effect fifteen days from the date of publication in the Official Gazette.
适用范围
Pharmaceutical production, trading, storage, and preservation facilities in Vietnam
要点
- Pharmaceutical production facility → must apply the principles and standards of 'Good Manufacturing Practice for Medicines' according to the adjusted plan.
- Trading, storage, and preservation facilities → must apply the principles and standards of 'Good Storage Practice for Medicines' according to the adjusted plan.
🌐 本文件的社会影响
- Positive impact: Ensuring the quality of pharmaceutical products, enhancing safety for drug users.
- Negative impact: May increase operational costs for pharmaceutical production and trading facilities.
❓ 常见问题
To whom does this Decision apply?
This Decision applies to pharmaceutical production, trading, storage, and preservation facilities in Vietnam.
When will this Decision take effect?
This Decision shall take effect fifteen days from the date of publication in the Official Gazette.
What principles and standards must pharmaceutical production facilities apply?
Pharmaceutical production facilities must apply the principles and standards of 'Good Manufacturing Practice for Medicines' according to the adjusted plan.
What principles and standards must trading, storage, and preservation facilities apply?
Trading, storage, and preservation facilities must apply the principles and standards of 'Good Storage Practice for Medicines' according to the adjusted plan.
Who is responsible for organizing the implementation of this Decision?
The Director of the Vietnam National Drug Administration is responsible for organizing the implementation of the application of the principles and standards of 'Good Manufacturing Practice for Medicines' and 'Good Storage Practice for Medicines'.
全文
DECISION OF THE MINISTER OF HEALTH
Regarding adjustment of the plan to implement the principles and standards of "Good Manufacturing Practice for Medicines" issued together with Decision No. 3886/2004/QĐ-BYT on the implementation of the principles and standards of "Good Manufacturing Practice for Medicines" according to the recommendations of the World Health Organization and "Good Storage Practice for Medicines" issued together with Decision No. 2701/2001/QĐ-BYT on the implementation of the principle of "Good Storage Practice for Medicines"
the Good Manufacturing Practice for Medicines issued together with Decision No. 3886/2004/QĐ-BYT
dated November 3, 2004 of the Minister of Health on the implementation of the principles and standards of "Good Manufacturing Practice for Medicines"
standards for Good Manufacturing Practice for Medicines according to the recommendations of the Organization
and "Good Storage Practice for Medicines" issued together with Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on the implementation of the principle of "Good Storage Practice for Medicines"
Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on
Pursuant to the Law on Protecting People's Health dated July 11, 1989;
___________________
THE MINISTER OF HEALTH
Pursuant to the Law on Protecting People's Health dated July 11, 1989;
Pursuant to the Ordinance on Product Quality dated December 24, 1999;
Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Considering the actual situation in implementing the principles and standards for Good Manufacturing Practice for Medicines and the principles for Good Storage Practice for Medicines at production, business, storage, and preservation facilities;
Pursuant to Decision No. 108/2002/QĐ-TTg dated August 15, 2002 of the Prime Minister approving the "Strategy for the Development of the Pharmaceutical Industry to 2010";
DECISION:
Article 1. Considering the actual situation of implementing the principles and standards of "Good Manufacturing Practice for Medicines" and the principle of "Good Storage Practice for Medicines" at production, trading, storage, and preservation facilities;
Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette.
Article 3. Considering the proposal of the Director of the Vietnam Drug Administration,
Article 4. This Decision hereby promulgates the adjusted plan for the implementation of the principles and standards of "Good Manufacturing Practice for Medicines" at medicine production facilities in Vietnam issued together with Decision No. 3886/2004/QĐ-BYT dated November 3, 2004 of the Minister of Health on the implementation of the principles and standards of "Good Manufacturing Practice for Medicines" according to the recommendations of the World Health Organization and the plan for the implementation of the principle of "Good Storage Practice for Medicines" at trading, preservation, and storage facilities in Vietnam issued together with Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on the implementation of the principle of "Good Storage Practice for Medicines".
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