In which, the Ministry of Health proposed to regulate the temporary suspension of business, use and sealing of drug storage with signs of being unsafe for users.
This Circular provides detailed instructions on the application of drug quality standards ( pharmaceutical drugs, medicinal herbs, vaccines, biological products), pharmaceutical ingredients, except for pharmaceutical ingredients); testing of drugs, pharmaceutical ingredients and procedures for recalling and handling violating drugs.
According to the draft, drugs with signs of being unsafe for users include:
1- Drugs that have reported harmful reactions with severe severity or repeat, related to the drug but not a known harmful reaction of the drug;
2- Drugs suspected of containing substances and impurities that exceed safety limits for users;
3- Drugs suspected of not meeting quality standards;
4- Drugs suspected of showing signs of counterfeiting or of unknown origin;
5- Pharmaceuticals produced from ingredients of unknown origin or that do not meet quality standards;
6- Drugs suspected of being produced at the production facility have seriously violated the principles and standards of Good practice in the production of drugs and pharmaceutical ingredients or have not been confirmed by the pharmaceutical management agency to be eligible to maintain drug production.
According to the draft, within no more than 7 working days from the date of receipt of information about drugs showing signs of unsafety for users as prescribed, the Ministry of Health (Department of Drug Administration) reviews the received information, coordinates with at least one of the agencies and professional organizations (Consulting Council for granting certificates of registration for drug circulation and pharmaceutical ingredients; Council for advising on the use of vaccines; Central Institute for Drug Testing; Ho Chi Minh City Institute for Drug and Biological Testing; National Institute for Inspection of Vaccine and Biological Examination; Council for drugs and treatment at special-class hospitals) or inspection agencies, police, customs, and market management agencies if necessary, to assess the risk of affecting the health of users, determine the violation of temporary suspension of trading, and determine the use of drugs with signs of unsafe use for users.
Within no more than 3 days from the date of conclusion that the drug is at risk of affecting the health of the user, the Ministry of Health (Department of Drug Administration) shall issue a document notifying the temporary suspension of production, import, distribution, use and sealing of one or a number of drug batches or drug items with signs of not ensuring safety for users.
The suspension period for business, use and sealing of drug storage with signs of not ensuring safety for users to verify is as follows: The suspension period is not more than 02 months from the date of issuance of the document. In case of complication or due to incomplete technical conditions for domestic drug analysis and testing, the suspension period can be extended to no more than 02 months.
If the above deadline is exceeded, in case the police, market management, customs and inspection agencies have a written request to continue to temporarily suspend business and use to serve the investigation and verification process, the temporary suspension period will be extended based on current regulations and at the request of the above authorities.
