THE MINISTRY OF HEALTH

Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Ministry of Health on drug registration
Pursuant to the Law on Pharmacy No. 34/2005/QH11 dated June 14, 2005;
Pursuant to the Government's Decree No. 63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;
At the request of the Director of the Drug Administration of Vietnam and the Director of Department of Medical Equipment and Health Works,
The Minister of Health promulgates a Circular on registration of drugs.
Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular provides for the registration of drugs for human use permitted for sale in Vietnam.
Article 2. Interpretation of terms
For the purposes of this Circular, these terms below shall be construed as follows:
1. Modern drug means a drug containing active ingredients whose composition, formula and purity have been identified.
2. New active ingredient means an active ingredient contained in the drug which is registered for permission for sale (hereinafter referred to as registered) in Vietnam for the first time.
3. Generic drug means a finished drug, usually intended to be interchangeable with an innovator product, which is manufactured without a franchise agreement from the innovator company and sold after the expiry date of the patent or other exclusive rights.
4. Drug manufactured under a franchise agreement means a drug of a Vietnamese or foreign drug manufacturer bearing a drug registration number in Vietnam or overseas which is manufactured under a franchise agreement between the aforesaid manufacturer and another manufacturer in Vietnam eligible for drug manufacturing.
5. Brand name of drug means the name of a drug other than its generic name or international nonproprietary name.
6. ASEAN common technical dossier (ACTD) means a set of documents providing guidance on drug registration application to meet common technical requirements of the Association of Southeast Asian Nations (ASEAN) as mentioned in Appendix No. I of The ASEAN common technical dossier and technical requirements issued together with this Circular.
7. Major variation means a variation which directly and greatly affects quality, safety and efficacy of a drug, as mentioned in the Appendix II on Major variations, minor variations, and other variations related to drugs bearing drug registration numbers (hereinafter referred to as registered drug) issued together with this Circular.
8. Minor variation means a variation which hardly or slightly affects quality, safety and efficacy of a drug, as mentioned in the Appendix II on major variations, minor variations, and other variations related to registered drugs issued together with this Circular.