Procedure for issuing circulation license for drug materials

1

Receiving Authority

Drug Administration of Vietnam – Ministry of Health (the “DAV”)

2

How to submit the dossier

An entity applying for a circulation license for drug materials (an "entity") shall submit an application in one of the following forms:

• In person
• Online
• By post

3

Processing time

Maximum 12 months from the date of receipt of complete documents

4

Dossier composition

01 dossier includes[1]:

Administrative documents[2]:

1. Form No. 5A/TT attached to the Circular 08/2022/TT-BYT;
2. Power of attorney on behalf of the entity (if any);
3. Power of attorney to sign on the registration dossier (if any);
4. The sample label, package insert of the drug product to be marketed;
5. The Certificate of Eligibility for Pharmacy Business (for Vietnamese entities);
6. Legal documents, the license to establish a representative office in Vietnam (for foreign entities);
7. Legal documents of the manufacturer of active ingredients, excipients, capsule shells, semi-finished and finished herbal ingredients;
8. The certificate of the testing laboratory for manufacturers who do not comply with GMP according to the Roadmap of the Ministry of Health or those required by the DAV according to Appendix III of the Circular 08/2022/TT-BYT, which must be certified by a State Drug Testing Laboratory that meets GLP requirements or an entity providing drug and drug ingredient testing services that has a certificate of eligibility;
9. The sample label and package insert of the drug actually marketed in the country of origin or the country where the CPP is issued (for foreign entities);
10. The CPP (for foreign entities);
11. Documents assessing compliance with GMP for the cases specified in Article 95 of the Decree 54/2017/ND-CP for foreign manufacturers of drugs and drug materials when registering circulation in Vietnam for foreign drug registration dossiers (except for cases where the entity has been published information on compliance with GMP on the website of the DAV or the entity has submitted a dossier to request the DAV to assess compliance with GMP).

Quality documents[3]:

1. For active ingredients: Documents for active substances specified in the ACTD. Submission of the Drug Master File if the manufacturer's specifications are applied.
2. For semi-finished active ingredients: The same documents specified in the ACTD as those for drug products, in which the documents with the drug product documents replaced by the semifinished drug product documents; the formula of a single dose or the smallest packaging unit is replaced by the batch formula.
3. For semi-finished herbal ingredients, excipients and capsule shells:

5. Preparation formula for semi-finished herbal ingredients, excipients in premixed form, capsule shell: ingredients, weight, volume, quality standards of each ingredient in the formula. If materials of animal origin are used, information on the accompanying substances must be provided (viral safety data);
5. Manufacturing process

• Manufacturing Process Map: shows all stages of the manufacturing process, including the path of materials, and is consistent with the manufacturing process description;
• Manufacturing Process Description: a complete and detailed description of the steps performed at each stage of the manufacturing process, including full technical specifications for each stage;
• Equipment list: names, specifications and uses of each piece of equipment;
• Control of the manufacturing process: Describe in detail the control criteria for each stage, including the criterion, acceptance standards, control method, control frequency and sample size.

5. Quality standards and testing method

• For semi-finished herbal ingredients: apply the same regulations on quality standards and test methods for herbal ingredients other than semi-finished herbal ingredients as specified in the Circular 38/2021/TT-BYT;
• For excipients and capsule shells: comply with the Circular 11/2018/TT-BYT.

5. The test report;
5. Standard of packaging: Describe in detail the packaging material, quality criteria, quality levels and test method;
5. Stability study report, including stability study outline; stability study data; results and discussion.

5

Fees

VND 5.500.000/dossier

6

Result

Circulation license for drug materials