Medicine registration for circulation in Vietnam

Required documents:

I. Administrative records and product information

  1. Cover page (Form 1/TT)
  2. Table of content;
  3. Application for registration (Form 2A/TT);
  4. Authorization Letter (if any) (Form 3/TT);
  5. The Certificate of operating in medicine, medicine raw material in Vietnam;
  6. CPP Certificate;
  7. FSC Certificate if foreign medicine company does not have CPP;
  8. GMP Certificate of the foreign manufacturing company if the medicine registration unit hands the FSC or CPP Certificate without confirmation of GMP standards. In case many manufacturing units took place in the process of medicine manufacture, the medicine registration unit must hand GMP Certificates of all these manufacture units;
  9. Labeling materials: 02 sets of designed labeling materials. For foreign medicine, 01 original set of labeling materials circulating in country of origin is also required. These materials are enclosed into the A4 paper with stamp of registration unit or manufacture unit.
  10. Product information: Package insert for generic medicine with stamp of registration unit or manufacture unit.
  11. The overall record of manufacturer (Form 4/TT). In case one product is produced through many steps, overall record must be the record of all manufacturer joining processes of making the product before delivering to the market.

II. Quality record will be prepared under the guidance in Part II – ACTD and include the following documents:

  1. Table of content;
  2. General summary on quality;
  3. Content and figure;
  4. Reference materials;

For specific requirement of the quality record, please refer to the below for your preparation:

New requirements on quality record

I.    Drug substance
1.    General information
1.1  Nomenclature
1.2  Structure
1.3  General properties

2.    Manufacturer
Name and add of the manufacturer
3.    Characterisation
3.1  Elucidation of Structure and other characteristics
3.2  Impurities

4.    Control of Drug Substance
4.1  Specification
4.2  Analytical procedures
4.3    Validation of Analytical procedures

5.    Reference standards or materials
6.    Stability

II.    Drug product
1.    Description and composition
2.    Pharmaceutical development
2.2  Components of the drug product
2.3  Finished product
2.5  Container closure system
2.6  Microbiological Atrributes
2.7  Compatibility

3.    Manufacture
3.1  Batch formula
3.2  Manufacturing process and process control
3.3  Control of critical steps and intermediates
3.4  Process validation and/or evaluation

4.    Control of excipients
4.1  Specifications
4.2  Analytical procedures
4.3  Excipient of human or animal origin

5.    Control of finished product
5.1  Specification
5.2  Analytical procedures
5.3  Validation of analytical procedures
5.5  Characterisation of Impurities
5.6  Justification of specification

6.    Reference standards or materials
7.    Container closure system
8.    Stability
9.    Interchangeability Equivalence evidence (not required if the pharmaceutical product is generic)

Time frame

Under the Vietnamese legal regulation, it takes 06 months, then the Ministry of Health will issue a Notification requesting the supplementation or amendment. Therefore, it normally takes up to 8-9 months to obtain visa number after accurate and sufficient amendment. However, after executing the new regulations on medicine registration, it may take 12-15 months to obtain visa.

Renewal of medicine registration

Medicine registration for circulation in Vietnam, Pharmaceutical product license

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