CHECKLIST FOR REGISTRATION OF NEW MODERN DRUGS, VACCINES, BIOLOGICALS IN VIETNAM

Medicine, vaccines, biologicals are special commodities, directly related to the health and life of people. The State currently has strict regulations on these kinds of goods registration activities. In this article, Doanh Tri Law Firm will provide an overview of the in-need checklist for registration of new modern drugs, vaccines, biologicals in Vietnam.
I. Legal basis
- Law on Pharmacy 2016;
- Circular 32/2018/TT-BYT on marketing authorization of drugs and medicinal ingredients.

II. General provisions
1. What is drug registration?
Drug registration is the activity of applying for a circulation permit (marketing registration) for drug products (drugs, vaccines, biological products) under the management of the Ministry of Health, in order to ensure that the drugs are circulated in compliance with the regulations. 
2. Regulatory authorities
Pharmaceutical products in Vietnam are under the management of the Ministry of Health (MOH).
The Drug Administration of Vietnam (DAV) is one of the divisions under the Ministry of Health (MoH) and it handles the overall responsibility for the registration of pharmaceutical products to market in Vietnam.
3. Who can apply for registration of a new modern drug product in Vietnam?
The following entities are allowed to register pharmaceutical products in Vietnam.
- Domestic pharmaceutical manufacturers.
- Foreign companies, having a license to manufacture pharmaceuticals in Vietnam.
- Domestic entities that are allowed to trade in pharmaceuticals.
- Foreign entities who have a trade license.

III. Checklist for registration of new modern drugs, vaccines, biologicals in Vietnam
1. Administration dossier
- Cover page form 07/TT
- Table of content
- Application registration Form 6A/TT
- Authorization letter for Registration ( if any) Form 05/TT
- Drug manufacturing, the trading license granted by the foreign competent agencies and License for representative office establishment in Vietnam of foreign registers/ License conducting an operation in medicine, the medicinal material field in Vietnam of foreign registrars
- Drug label (artwork design, package insert): 03 set
- Summary of Product Characteristics pertaining to new modern drugs, vaccines, antibody-containing sera, and biologicals
- A franchise agreement on drug manufacturing. Outsourcing agreement on drug manufacturing (if any)    
- Certificates, protection titles, and transfer contracts for ownership of industrial property objects (if any)
- Actual drug label of the original country or reference country for imported drugs.
2. Manufacturing condition evaluating dossier
- GMP or Good manufacturing practice inspection report/ the manufacturing license granted by the competent agency.
- Site master file on the manufacturing facility conforming to the guidelines of EU or PIC/S or WHO
- Quality Manual of Manufacturer
- List of Good manufacturing practice inspections performed by the pharmaceutical regulatory authority of the establishment’s home country
- List of the drugs along with dosage forms, drug raw materials that have been supplied or are intended to be supplied to VN
- Batch release process for drugs, drug raw materials intended to be registered for marketing in VN
- Reports on periodic quality reviews with regard to the registered drugs, drug raw materials being of sterilized form.

3. Quality Documents
3.1. Quality overall summary
3.2. Body of data
* Drug substances
- General information (S1)
- Manufacture 
- Characterization
- Control of drug substance
- Reference standards or materials
- Container closure system
- Stability    
* Drug product
- Description and Composition of the Drug product
- Pharmaceutical development
- Manufacture
- Control of Finished product
- Container closure system
- Stability
* Certificate of Analysis (CoA)
* Site Master file of Manufacturer Form 10/TT
* Report (if any)
4. Clinical Documents
- Clinical overview
- Clinical Summary    
- Tabular Listing of All Clinical Studies                 
- Clinical Study Reports    
The above information is about the ‘Checklist for registration of new modern drugs, vaccines, biologicals in Vietnam.' For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:
Hotline: (+84) 911.233.955 - (024) 6293 8326
Email: [email protected]
Doanh Tri Law Firm is pleased to accompany our Customers!