Decision No. 29/2007/QD-BYT supplements certain contents of the principles and standards of "Good Pharmacy Practice" and "Good Distribution Practice for medicinal products", requiring the Department of Health to issue certificates of compliance to healthcare facilities. The Decision shall take effect fifteen days from the date of publication in the Official Gazette.
적용 범위
Departments of Health of provinces and centrally governed cities; pharmaceutical business establishments and pharmacies.
핵심 사항
- Healthcare facility → receives a Certificate of Compliance with the standard of "Good Pharmacy Practice" according to Form 3 in the Appendix.
- Departments of Health of provinces and centrally governed cities → issue Certificates of Compliance with the standard of "Good Distribution Practice for medicinal products" to pharmaceutical business establishments according to Form 3 in the Appendix.
- Pharmaceutical business establishment → applies the principle of "Good Distribution Practice for medicinal products" from January 1, 2008, the validity period of the certificate of eligibility for pharmaceutical business operations is applied according to Article 29 of Decree No. 79/2006/NĐ-CP.
- The principle of "Good Distribution Practice for medicinal products" → supplements Section 1 Part III and Point d Subsection 6 Part III Guidance on Implementation.
🌐 이 문서의 사회적 영향
- Healthcare facilities and pharmacies will have to comply with new regulations, which may increase costs for upgrading physical infrastructure to meet the standards.
- Departments of Health will strengthen management and supervision work, helping to improve the quality of healthcare services and drug safety in the market.
❓ 자주 묻는 질문
What must pharmaceutical business establishments do to obtain a Certificate of Compliance with the standard of "Good Distribution Practice for medicinal products"?
Pharmaceutical business establishments must comply with the new principles and standards, then apply for the certificate from the Department of Health according to Form 3 in the Appendix.
What is the validity period of the Certificate of Eligibility for Pharmaceutical Business Operations?
The validity period of the certificate is applied according to Article 29 of Decree No. 79/2006/NĐ-CP.
Are there any changes to the principle of "Good Pharmacy Practice"?
Point e Clause 2 Section II Chapter III of the principles and standards of "Good Pharmacy Practice" has been supplemented to enable the Department of Health to issue Certificates of Compliance according to Form 3 in the Appendix.
Are there any changes to the principle of "Good Distribution Practice for medicinal products"?
Section 1 Part III and Point d Subsection 6 Part III Guidance on Implementation of the principle of "Good Distribution Practice for medicinal products" have been supplemented.
When does this Decision come into effect?
This Decision shall take effect fifteen days from the date of publication in the Official Gazette.
전문
Pursuant to …;
Regarding supplementing certain contents of the principles and standards of the "Good Pharmacy Practice" issued together with Decision No. 11/2007/QĐ-BYT dated January 24, 2007 of the Minister of Health and the principle of "Good Distribution Practice for medicinal products"issued together with Decision No. 12/2007/QĐ-BYT dated January 24, 2007 of the Minister of HealthPursuant to the Medicine Law No. 34/2005-QH11 dated June 14, 2005;Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government detailing the functions, tasks, powers, and organizational structure of the Ministry of Health;Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of some articles of the Medicine Law;
____________________
THE MINISTER OF HEALTH
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";
Considering the proposal of the Director of the Vietnam National Medicines Administration,
Supplementing certain contents of the principles and standards of the "Good Pharmacy Practice" issued together with Decision No. 11/2007/QĐ-BYT dated January 24, 2007 of the Minister of Health as follows:
1. Supplementing Point e Clause 2 Section II Chapter III of the principles and standards of the "Good Pharmacy Practice" issued together with Decision No. 11/2007/QĐ-BYT dated January 24, 2007 of the Minister of Health: - The People's Committee of Health of the province or centrally governed city issues the Certificate of Compliance with Good Pharmacy Practice Standards according to Form 3 in the Appendix.
2. Supplementing Appendix 3 specifying the form of the certificate of compliance with Good Pharmacy Practice standards.
DECISION:
Article 1. Supplementing certain contents of the principle of "Good Distribution Practice for medicinal products" issued together with Decision No. 12/2007/QĐ-BYT dated January 24, 2007 of the Minister of Health as follows:
1. Supplementing Item 1 Part III Guidance on Implementation in the Principle of "Good Distribution Practice for medicinal products" issued together with Decision No. 12/2007/QĐ-BYT dated January 24, 2007 of the Minister of Health:
a) Before January 1, 2008, the principles stipulated in Decision No. 12/2007/QĐ-BYT shall be applied to supplement the scope of business, extend the validity of the certificate of eligibility for pharmaceutical business, or change the location of pharmaceutical business, except for the provisions in Items 3, 5, 7, 10, 15, and 16 of Part II of the principle of "Good Distribution Practice for medicinal products".
Article 2. b) The validity period of the supplementary, extended, or relocated certificate of eligibility for pharmaceutical business shall be implemented according to Article 29 of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of some articles of the Medicine Law, and the entity must meet the implementation schedule of the principle of "Good Distribution Practice for medicinal products".
2. Supplementing Point d Item 6 Part III Guidance on Implementation of the principle of "Good Distribution Practice for medicinal products" issued together with Decision No. 12/2007/QĐ-BYT dated January 24, 2007 of the Minister of Health:
- The People's Committee of Health of the province or centrally governed city issues the Certificate of Compliance with Good Distribution Practice for medicinal products according to Form 3 in the Appendix.
3. Supplementing Appendix 3 specifying the form of the certificate of compliance with Good Distribution Practice for medicinal products.
The Director of the Vietnam National Medicines Administration is responsible for guiding, inspecting, and monitoring the implementation of this Decision.
The Head of the Office, the Inspector General of the Ministry of Health, the Director of the Vietnam National Medicines Administration, the Heads of units under the Ministry, the Directors of Provincial Health Services, and the Health Services of sectors are responsible for enforcing this Decision./.
Cao Minh Quang
Article 3. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.
Article 4. The Director of the Vietnam Medicine Administration shall be responsible for guiding, inspecting, and monitoring the implementation of this Decision.
Article 5. The Head of the Office, the Inspector General of the Ministry of Health, the Director of the Vietnam Medicine Administration, the Heads of units under the Ministry, the Directors of Provincial Health Services under central cities and provinces, and the Health Departments of sectors shall be responsible for enforcing this Decision./.
DEPUTY MINISTER
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