Circular No. 44/2011/TT-BYT of the Ministry of Health stipulates the List of Products and Commodities with Potential to Cause Safety Hazards within the Scope of Management of the Ministry of Health and provides guidelines for quality management of products listed therein.
Scope of application
The Ministry of Health, the state management agency for health, pharmaceutical enterprises, medical equipment manufacturers, medical chemicals producers, and individuals using products and commodities listed in the said list.
Key points
- The Ministry of Health issues the List of Products and Commodities with Potential to Cause Safety Hazards comprising six groups: finished pharmaceuticals, vaccines, therapeutic biological products; drug ingredients, medicinal herbs, excipients, capsule shells, direct contact pharmaceutical packaging; medical devices; chemicals, insecticides, disinfectants for household and medical use; toxic traditional Chinese medicines; and traditional medical equipment.
- Quality management of products and commodities under this List shall be carried out in accordance with national technical regulations issued by the Minister of Health.
🌐 Social impact of this document
- Positive impact: Ensuring safety for users of healthcare products and commodities through stringent quality management.
- Negative impact: Increased production and business costs for enterprises due to compliance with quality management regulations.
❓ Frequently asked questions
What does the List of Products and Commodities with Potential to Cause Safety Hazards include?
This List includes six groups: finished pharmaceuticals, vaccines, therapeutic biological products; drug ingredients, medicinal herbs, excipients, capsule shells, direct contact pharmaceutical packaging; medical devices; chemicals, insecticides, disinfectants for household and medical use; toxic traditional Chinese medicines; and traditional medical equipment.
How is quality management of products and commodities under this List carried out?
Quality management of products and commodities under this List shall be carried out in accordance with national technical regulations issued by the Minister of Health and other relevant legal provisions.
When does this Circular take effect?
This Circular takes effect from March 1, 2012.
What does the second group of products and commodities in the List include?
The second group of products and commodities in the List includes: finished pharmaceuticals, vaccines, therapeutic biological products; drug ingredients, medicinal herbs, excipients, capsule shells, direct contact pharmaceutical packaging; medical devices; chemicals, insecticides, disinfectants for household and medical use; toxic traditional Chinese medicines; and traditional medical equipment.
To whom should issues encountered when implementing this Circular be reported?
If there are any issues, agencies, organizations, and individuals shall promptly report them to the Ministry of Health for review and appropriate amendments.
Full text
Article 1. Issuance of the list
Issued together with this Circular is the List of products, goods potentially causing safety risks within the scope assigned to manage by the Ministry of Health (hereinafter referred to as the List of products, goods Group 2), comprising six groups of products, goods:
1. Finished pharmaceutical products, vaccines, therapeutic biological products.
2. Raw materials for drugs, medicinal herbs, excipients, drug capsules, direct contact pharmaceutical packaging.
3. Medical devices.
4. Chemicals, insecticides, bactericides for household and medical use.
5. Toxic traditional Chinese medicine ingredients.
6. Traditional medical equipment.
Article 2. Quality Management of Products and Goods
The quality management of products and goods listed in the List of products, goods Group 2 as stipulated in this Circular shall be carried out in accordance with the corresponding national technical regulations issued by the Minister of Health and other relevant laws and regulations.
Article 3. Effectiveness
This Circular takes effect from March 1, 2012.
During the implementation, if there are any difficulties, agencies, organizations, and individuals shall promptly report to the Ministry of Health for review and appropriate amendments and supplements./.
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