This Circular abolishes in whole or in part regulatory legal documents issued by the Minister of Health related to quality testing, food safety hygiene, pharmaceutical packaging production, medical equipment for disease prevention, and treatment for individuals exposed to HIV. This ensures the currency and effectiveness of the legal system in the healthcare sector.
Scope of application
Retail drug outlets within hospitals; units under the Ministry of Health; Provincial Health Departments, centrally governed cities
Key points
- Abolish entirely Circular No. 13/2011/TT-BYT on tiered quality testing and food safety hygiene in the health sector.
- Abolish partially Circular No. 15/2011/TT-BYT on the organization and operation of retail drug outlets within hospitals, specifically Article 1, Article 2, Article 3, and other related articles.
- Abolish entirely Joint Circular No. 10/2005/TTLT-BYT-BTC on treatment for individuals exposed to HIV due to occupational accidents.
- Continue to allow the operation of retail drug outlets within hospitals organized according to Clause 1 and Clause 2, Article 3 of Circular No. 15/2011/TT-BYT.
- Abolish partially Circular No. 14/2012/TT-BYT on principles and standards for good manufacturing practices for pharmaceutical packaging.
🌐 Social impact of this document
- Reduce burdensome regulations that are no longer appropriate or require updating.
- Simplify state management procedures in the healthcare sector, reducing the burden on businesses and healthcare facilities.
- Create more favorable conditions for the production and business operations of drugs and medical equipment.
- Relevant organizations and individuals need to update new regulations to ensure compliance with the law.
❓ Frequently asked questions
Which documents does this Circular abolish?
This Circular abolishes in whole or in part Circular No. 13/2011/TT-BYT, Joint Circular No. 10/2005/TTLT-BYT-BTC, and many other documents.
Are retail drug outlets within hospitals affected?
This Circular allows these outlets to continue operating according to current laws on pharmaceuticals, bidding, and public asset management.
Are traditional medical techniques abolished?
This Circular abolishes traditional medical techniques issued together with Decision No. 26/2008/QĐ-BYT.
When does this Circular take effect?
This Circular takes effect from December 15, 2024.
Which agencies and organizations need to be informed about this Circular?
This Circular is sent to the National Assembly's Social Committee, Government Office, Ministry of Justice, and units under the Ministry of Health.
Full text
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
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Number: 25/2024/TT-BYT |
Hanoi, October 30, 2024 |
CIRCULAR
Repealing in whole or in part certain regulatory legal documents issued by the Minister of Health, jointly issued
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Pursuant to the Law on Legislative Regulatory Documents dated June 22, 2015 and the Law Amending and Supplementing Certain Provisions of the Law on Legislative Regulatory Documents dated June 18, 2020;
Pursuant to Decree No. 34/2016/NĐ-CP dated May 14, 2016 of the Government detailing some provisions and implementing mechanisms of the Law on Enacting Regulatory Legal Documents; Decree No. 154/2020/NĐ-CP dated December 31, 2020 of the Government amending and supplementing some articles of Decree No. 34/2016/NĐ-CP dated May 14, 2016 of the Government detailing some provisions and implementing mechanisms of the Law on Enacting Regulatory Legal Documents; Decree No. 59/2024/NĐ-CP dated May 25, 2024 of the Government amending and supplementing some articles of Decree No. 34/2016/NĐ-CP dated May 14, 2016 of the Government detailing some provisions and implementing mechanisms of the Law on Enacting Regulatory Legal Documents which have been amended and supplemented some articles according to Decree No. 154/2020/NĐ-CP dated December 31, 2020 of the Government;
Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
At the proposal of the Director of the Department of Legal Affairs, the Director of the Food Safety Agency, the Director of the Infrastructure and Medical Equipment Agency, the Director of the Drug Administration, the Director of the Traditional Medicine and Drugs Administration, the Director of the HIV/AIDS Prevention and Control Agency;
The Minister of Health issues this Circular to repeal in whole or in part certain regulatory legal documents issued by the Minister of Health, jointly issued,
Article 1. Repealing in full four regulatory legal documents issued by the Minister of Health, jointly issued
1. Circular No. 13/2011/TT-BYT dated March 31, 2011 of the Minister of Health guiding the demarcation of tasks, inspection indicators, and inspection procedures serving state management of quality and food safety in the healthcare sector.
2. Circular No. 02/2016/TT-BYT dated January 12, 2016 of the Minister of Health supplementing Article 9 of Circular No. 14/2012/TT-BYT dated August 31, 2012 of the Minister of Health stipulating principles and standards for "Good Manufacturing Practices for Pharmaceutical Packaging" and guidance on implementation.
3. Circular No. 06/2022/TT-BYT dated August 1, 2022 of the Minister of Health stipulating the list and circulation numbers for medical equipment serving the prevention and control of COVID-19 in emergency situations.
4. Joint Circular No. 10/2005/TTLT-BYT-BTC dated March 30, 2005 of the Ministry of Health and the Ministry of Finance guiding the implementation of regulations for individuals exposed to HIV or infected with HIV due to occupational accidents as stipulated in Decision No. 265/2003/QĐ-TTg dated December 16, 2003 of The Prime Minister.
Article 2. Repealing in part four regulatory legal documents issued by the Minister of Health
1. Article 1; Article 2; Article 3; Clause 1, Clause 2 and Clause 6 of Article 6; Article 7; Article 8 and Article 9 of Circular No. 15/2011/TT-BYT dated April 19, 2011 of the Minister of Health stipulating the organization and operation of retail pharmacies within hospitals.
2. Article 7 and Article 8 of Circular No. 45/2011/TT-BYT dated December 21, 2011 of the Minister of Health amending and supplementing some articles of Decision No. 1570/2000/QĐ-BYT dated May 22, 2000 of the Minister of Health on the implementation of the principle of "Good Laboratory Practice for Pharmaceutical Testing"; Decision No. 1570/2000/QĐ-BYT dated May 22, 2000 of the Minister of Health on the implementation of the principle of "Good Laboratory Practice for Pharmaceutical Testing"; 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 Pharmaceuticals"; Circular No. 06/2004/TT-BYT dated May 28, 2004 guiding the production and processing of pharmaceuticals; Decision No. 3886/2004/QĐ-BYT dated November 13, 2004 of the Ministry of Health on the implementation of principles and standards of "Good Manufacturing Practice for Pharmaceuticals" according to the recommendations of the World Health Organization; Circular No. 13/2009/TT-BYT dated September 1, 2009 of the Ministry of Health guiding advertising activities for pharmaceuticals; Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health stipulating drug registration; Circular No. 47/2010/TT-BYT dated December 29, 2010 guiding export and import of pharmaceuticals and direct contact pharmaceutical packaging.
3. Clause 5 of Article 9 of Circular No. 14/2012/TT-BYT dated August 31, 2012 of the Minister of Health stipulating principles and standards for "Good Manufacturing Practice for Pharmaceutical Packaging" and guidance on implementation.
4. Technical procedures: diagnosis by auscultation; diagnosis by palpation; diagnosis by questioning; diagnosis by inspection; traditional medicine diagnosis; prescription of traditional medicine; treatment procedure for internal hemorrhoids; treatment for fistula-in-ano; fumigation procedure; decoction procedure; exercise therapy; consumption of decoctions; soaking in medicinal baths; steam inhalation procedure; traditional medicine steam inhalation; treatment by soaking and steaming; surgery using machine ZZ2D and combined traditional medicine treatment; laser CO2 hemorrhoidectomy procedure issued together with Decision No. 26/2008/QĐ-BYT dated July 22, 2008 of the Minister of Health on issuing technical procedures for traditional medicine.
Article 3. Transitional Provisions
Retail pharmacies within hospital premises organized in accordance with Clause 1 and Clause 2 of Article 3 of Circular No. 15/2011/TT-BYT shall continue to operate and comply with current laws and regulations on pharmaceuticals, bidding, asset management and utilization, and other relevant laws.
Article 4. Implementation provisions
1. This Circular takes effect from December 15, 2024.
2. The Director of the Office of the Ministry, the Director of the Department of Legal Affairs, the Director of the Inspectorate of the Ministry, the Directors of Departments and Agencies under the Ministry of Health, and related agencies, organizations, and individuals are responsible for implementing this Circular./.
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