TBT BSN | Notification

Notification Detail :: G/TBT/N/VNM/331

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

The draft Circular guiding the registration of finished medical products and medicinal ingredients

Objective

Harmonization (TBT)

Product Covered

Medicinal finished products and medicinal ingredients

Document Notification

Link to ePing

HSCODE

ICSCODE

11.120 - Pharmaceutics

Keywords

Human health

Specific Regions

Description

1. This draft Circular specifies:a) Documentation requirements, procedures for the issuance, renewal, revision and revocation of marketing authorization for modern medicines, vaccines, biologicals, herbal drugs and medicinal materials (including active ingredients, semi-finished herbal ingredients, excipients, and capsule shells) for human use in Vietnam;b) Required clinical data to ensure safety and efficacy in the application;c) Requirements for exemption from clinical trial or certain phases thereof in Vietnam; drugs to be subjected to Stage 4 clinical trial;d) Rules for the validation of marketing authorization applications (hereinafter referred to as "marketing application") for drugs/medicinal materials, their renewal and revision;dd) Rules for the validation of applications for license to import drugs that are yet to beapproved for marketing authorization (hereinafter referred to as "unapproved drugs") in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam (hereinafter referred to as"Decree No. 155/2018/ND-CP");e) Organizing and operating principles of the Advisory Council for issuance of marketing authorization of drugs and pharmaceutical ingredients (hereinafter referred to as the Council);g) Procedures for the assessment of applications for the granting, extension, variation of marketing authorizations for finished medical products and medicinal ingredients; procedures for the assessment of applications for import licenses of drugs without marketing authorization.h) Dossier and procedures for granting certificates of circulation of drugs in the form of reference and recognition;i) Regulations on drugs that must undergo bioequivalence testing and requirements for dossiers reporting bioequivalence research data in drug circulation registration in Vietnam.2. This draft Circular does not apply to the cases specified in Point a, b, Clause 2, Article 54 of the Law on Pharmacy, excipients, capsule shells, and semi-finished medicinal products for the manufacture of drugs according to drug registration dossiers that have a Certificate of Drug Circulation Registration in Vietnam; capsule shells, excipients used for testing, research or manufacturing of exported drugs and semi-finished medicinal products produced by the manufacturing facility itself for the manufacture of finished drugs, except in cases where the registration facility voluntarily request it.

Notified Document

1:File here

Link to Notification

EN:File here

Status Active

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Notification Detail :: G/TBT/N/VNM/331

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