Ministry of Health: Extension of circulation registration certificates for 32 vaccines and biological products


According to the Drug Administration of Vietnam, this is the 44th round of issuance and renewal of circulation registration certificates, including: 5 biological products issued with circulation registration certificates with registration numbers with the symbol SP3-…-22, valid for 3 years. from June 17; 3 vaccines have been extended circulation registration certificates valid for 5 years.

According to the Drug Administration of Vietnam, these vaccines keep their registration number information that has been issued; 4 biological products have been extended the circulation registration certificate valid for 3 years. The Drug Administration of Vietnam stated that, for these biological products, their registration number information is kept intact; 20 biological products have been extended the circulation registration certificate valid for 5 years. These biological products are kept with the registration number information that has been issued.

In the Decision, the Drug Administration of Vietnam clearly states that the manufacturer and the drug registration establishment are responsible for manufacturing and supplying drugs into Vietnam in accordance with the dossiers and documents registered with the Ministry of Health and must Print the registration number issued by the Ministry of Health of Vietnam on the drug label.

The Ministry of Health has just issued a decision to extend the circulation registration certificate for 32 vaccines and biological products.

Fully comply with Vietnamese laws and regulations of the Ministry of Health on production, import of drugs and drug circulation in Vietnam, if there is any change in the process of drug circulation in the host country and in the country. Vietnam must immediately report to the Drug Administration – Ministry of Health.

Update the quality standards of drugs according to the provisions of Circular No. 11/2018/TT-BYT of the Minister of Health regulating the quality of drugs and medicinal ingredients; Update drug labels and drug instruction sheets according to the provisions of Circular No. 01/2018/TT-BYT of the Minister of Health, providing for labeling of drugs, medicinal ingredients and instructions for drug use within a period of time. a period of 6 months from June 17 in the form of changes and supplements to the certificate of drug circulation registration specified in the Circular No. 32/2018/TT-BYT of the Minister of Health providing for the registration of drug circulation, medicinal ingredients.

According to the Drug Administration of Vietnam, after 12 months (from June 17), 27 vaccines and biological products have been extended their circulation registration certificates with changes in administrative content (including samples of labels, instruction sheets). instructions for use), must be manufactured (for domestically produced vaccines and biological products), imported (for imported vaccines and biological products), and circulated with approved contents and changes in the registration dossier. sign the extension.

Coordinate with preventive medicine and treatment facilities to strictly comply with current regulations on prescription drugs, monitor safety, effectiveness, and unwanted effects of drugs on Vietnamese people and synthesize .

The drug registration establishment must ensure to maintain operating conditions during the validity period of the certificate of registration for circulation of drugs and medicinal ingredients. In case the registration facility no longer meets the operating conditions, the registrant must change the registration facility in accordance with the provisions of Circular No. 32/2018/TT-BYT of the Minister of Health on regulations. to decide on the registration of circulation of drugs and medicinal ingredients within 30 days from the date on which the applicant no longer meets the operating conditions.

The drug registration establishment must report to the Ministry of Health on the update of the status of meeting good manufacturing practice of the manufacturer of the drug or medicinal ingredient.

In case the manufacturing establishment has its production license revoked or fails to meet good manufacturing practices for drugs and medicinal ingredients in the host country, it must make a report within 15 days from the date of issue. the notice of the competent management agency of the host country according to the provisions of point d, clause 1, Article 100 of the Government’s Decree No. 54/2017/ND-CP dated May 8, 2017 detailing a number of articles and Measures to enforce the Law on Pharmacy.

Bao Linh

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