Vietnam: MOH Proposes Revision for Drug & Medicinal Ingredients Registration & Circulation

ARQon
Nov 29, 2023
2 min read

The Ministry of Health of Vietnam (MOH) has taken a step forward in simplifying the registration and circulation of drugs and medicinal ingredients efficiently. On 19th November 2023, MOH proposed to revise a number of articles under Pharmacy Law for amendment and supplementation.

- Clause 2, Article 54:

The proposed amendment is to shorten the registration process for medicinal ingredients that have been used to produce drugs with registration certificates for circulation in Vietnam.

- Clause 6, Article 56:

No further extension is given for the circulation registration certificate of drugs and medicinal ingredients that have not been circulating within the validity period granted.

- Clause 2,3,4, Article 55 & Clause 1,3,5,6 Article 56:

Simplify the extending, changing, and supplementing procedures and dossiers for Registration Certificates.
Suggesting to shorten the renewal period for Circulation Registration Certificate (3 months shorten to 1 month). The extension submission for the Circulation Registration Certificate should be done 6 months prior to the expiry date.

- Clause 2, Article 56:

Allows replacement for the Certificate of Pharmaceutical Products (CPP) with other authorized or licensed documents as solid evidence during critical needs (national defenses, disease prevention and control)
Approve the results of an appraisal of the technical and clinical dossiers for drug registration dossiers and GMP certificates for the finished drug manufacturing facilities for new drugs licensed for circulation in foreign countries with the authorized agency, EMA.
Exemption of clinical dossier submission of the new drug that is developed locally for critical needs, with the same active ingredients, and dosage form, and has been licensed for circulation by any of the authorized authorities during the submission of the Circulation Registration Certificate application.

Overall, MOH will be able to reduce administrative tasks for the registration and circulation of drugs and medicinal ingredients and smoothen the procedure during the critical period, for instance during the disease pandemic. Furthermore, an efficient procedure may attract local and foreign manufacturers to establish new drug development in Vietnam’s market.

Source: Ministry of Health of Vietnam (MOH)