Nearly 500 types of drugs have been newly granted and their circulation registrations have been renewed.

The Drug Administration of Vietnam, Ministry of Health has just issued a decision on promulgating a list of 498 foreign drugs that are granted or have their circulation registration certificates renewed in Vietnam.

Accordingly, 219 foreign drugs were newly granted circulation registration certificates valid for 5 years; 9 foreign drugs were granted circulation registration certificates valid for 3 years;

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Regarding the extension, 231 foreign drugs had their circulation registration certificates extended for 5 years; 39 foreign drugs had their circulation registration certificates extended for 3 years.

The foreign pharmaceutical products newly granted and renewed registration certificates this time are quite diverse in terms of pharmacological effects such as drugs for treating respiratory tract infections; drugs for treating osteoarthritis; drugs for treating cardiovascular diseases, hypertension, diabetes, cancer treatment, antiviral drugs, antibiotics, pain relievers, anti-inflammatory drugs...

The Drug Administration of Vietnam requires that drug manufacturing and registration establishments are responsible for manufacturing and supplying drugs to Vietnam in accordance with the records and documents registered with the Ministry of Health and must print or affix the registration number issued by the Ministry of Health on the drug label;

Fully comply with Vietnamese laws and regulations of the Ministry of Health on drug production, import and circulation in Vietnam. If there is any change in the process of drug circulation in the home country and in Vietnam, it must be immediately reported to the Drug Administration of Vietnam, Ministry of Health of Vietnam...

The recent shortage of medicines is largely related to the issuance of new licenses and renewal of registrations for drugs and pharmaceutical ingredients.

Therefore, according to the representative of the Ministry of Health, the draft revised Law on Pharmacy has simplified the dossier for renewal, change, and supplement of registration certificates for circulation of drugs and pharmaceutical ingredients. It has streamlined administrative procedures, reduced the time for renewal and issuance of registration certificates for circulation of drugs and pharmaceutical ingredients.

Regarding the dossier, order and procedures for extending the validity of the circulation registration certificate for drugs and pharmaceutical ingredients: Clause 1, Article 56 of the 2016 Pharmacy Law stipulates that all drugs after the expiration of the Circulation Registration Certificate must re-submit the renewal dossier and these dossiers must go through the appraisal and approval process of the Advisory Council for the issuance of the Circulation Registration Certificate. This provision of the Pharmacy Law has contributed to the management of drugs with quality, safety and effectiveness.

However, the regulation is only suitable for drugs in circulation that have quality or safety problems that need to be re-evaluated before extending the validity of the circulation registration certificate.

In addition, in the draft revised Law on Pharmacy, the drafting committee proposed to stipulate cases of extension, change, and supplementation of the Circulation Registration Certificate that do not have to go through the Advisory Council for granting Circulation Registration Certificates for drugs and pharmaceutical ingredients or do not have to be approved.

Reduce the time to process records from 3 months to 15 working days for records of changes and additions that only need to be announced.

Supplementing regulations allowing establishments to continue using the circulation registration certificate after it expires and has submitted an application for renewal according to regulations until it is renewed or has a document from the Ministry of Health.

At the same time, a regulation is added allowing the replacement of CPP (Certificate of Pharmaceutical Product) with legal documents proving that the drug is licensed in cases where it meets the needs of disease prevention and control...

Source: https://baodautu.vn/gan-500-loai-thuoc-duoc-cap-moi-gia-han-dang-ky-luu-hanh-d227731.html