Eliminate 70% of mandatory documents for drug registration renewal applications

According to Circular 55 of the Ministry of Health, a series of changes in drug circulation registration and drug ingredients will be implemented.

This Circular is issued to amend and supplement a number of articles on extending the registration certificate for circulation of drugs and pharmaceutical ingredients in Circular No. 08/2022/TT-BYT of the Minister of Health regulating the registration of circulation of drugs and pharmaceutical ingredients.

Accordingly, previously, the term of a drug circulation registration certificate was 3 years, but according to the provisions of Circular 55, when the drug circulation registration certificate or drug ingredients expires and the Drug Administration has received the application for extension of the registration certificate, the enterprise can continue to use it until it is extended, or until the Drug Administration issues a written notice of non-extension, or a notice of temporary suspension of the use of the registration certificate due to the discovery that the drug or drug ingredients are unsafe for users or are suspected of forging legal documents.

According to a representative of the Drug Administration, the revised regulations on extending drug registration certificates are intended to avoid interruption of drug registration validity and ensure drug supply in all circumstances.

In addition, in Circular 55, the Ministry of Health also simplified administrative procedures for dossiers to renew circulation registration certificates. Previously, Circular 08 required dossiers to have 7 types of documents, but according to Circular 55, enterprises only need to provide 2 documents (for domestic drugs) and 3 documents (for imported drugs), helping to reduce hassle for enterprises.

The Ministry of Health has clearly stipulated cases of extension that must be approved by the Advisory Council for granting registration certificates for circulation of drugs and raw materials, and cases that do not need to be approved by the Advisory Council for granting registration certificates for circulation of drugs and raw materials.

This is a major change compared to Circular No. 08 which requires all extension cases to be approved and consulted by the Council.

The Ministry of Health also stipulates the deadline for publicizing information on renewal, information on receiving applications for renewal of circulation registration certificates, and written notices of non-renewal or suspension of use of circulation registration certificates due to detection of drugs that pose a risk of being unsafe for users, or suspected of forging legal documents on the Ministry of Health's electronic information portal and the Drug Administration Department's electronic information page.

Another new point of Circular 55 is to clearly stipulate cases where there is a change in administrative information of drugs and pharmaceutical ingredients requesting an extension of the circulation registration certificate, the registration facility shall follow the procedures for changing and supplementing regulations, except for changes in the name of drugs and ingredients which are made in the extension dossier and clearly stated in the Application for extension of the circulation registration certificate of drugs and pharmaceutical ingredients.

The Circular also stipulates the application form for renewal of the circulation registration certificate and the form for reporting the safety and effectiveness of the drug during circulation that the registration facility must submit when renewing according to the document requirements in the amended Law on Pharmacy.

Circular 57 also stipulates that within a maximum period of 03 months from the date of receiving a complete dossier, the Drug Administration shall extend the registration certificate for circulation of drugs and drug ingredients in the cases specified in Point c, Clause 2, Article 34 of this Circular. In case of non-extension or non-extension, the Drug Administration shall issue a written reply stating the reasons; the time for each step is prescribed.

Within 7 working days from the date of receiving the dossier, the Drug Administration shall review, classify and send the dossier to the appraisal experts or appraisal units. Within 1 month from the date of receiving the dossier from the Drug Administration, the appraisal experts or appraisal units must complete the appraisal record and send the Drug Administration to synthesize and conclude the appraisal record according to the provisions of Clause 4, Article 35 of this Circular.

Within 7 working days from the date of receipt of the appraisal report, the Drug Administration shall issue a written response to the unsatisfactory or unqualified appraisal dossier and state the reasons; Within 15 days from the date of receipt of the appraisal report and the qualified appraisal dossier, the Drug Administration shall issue a decision to extend the circulation registration certificate.