4. Supply of Ingredients

Ingredients Regulation Overview for Ingredient Manufacturers
Vietnam

This section provides information on any notification, registration, or importation requirements for the ingredient categories in scope.

4.1 As Drug Substances for Drug Manufacture (B2B)

4.1.1 Registration

4.1.1.1 Registration Requirements

The Pharmacy Act states that APIs must be registered before supply in Vietnam with the exception of materials that are APIs used for the manufacture of drugs that are already registered in Vietnam. 

In accordance with Decree No. 88/2023-ND-P, if the quality standards of an excipient are not included in Vietnam’s pharmacopeia or a recognized foreign pharmacopeia, that excipient must also be registered unless it is used for the manufacture of a drug that has been registered in Vietnam. 

Foreign manufacturers must have a representative in Vietnam to apply for registration or establish an office in Vietnam.

4.1.1.2 Registration Procedure

The procedure for registration is detailed in Circular 08/2022- “Regulations on Registration of Drugs and Drug Ingredients”. The application is submitted online by the Vietnamese representative.

The applicant is issued with a dossier receipt form if the submission satisfies the data requirements. Evaluation is then performed by designated experts or units assigned by the Ministry of Health. 

The product will be issued with a Certificate of Free Sale in Vietnam and registration number if the safety and quality requirements are fulfilled.

4.1.1.3 Documents required from ingredient supplier

Administrative Documents

All documents issued by a foreign competent authority must be consularly legalized.

1. Power of attorney to Vietnamese representative
2. Samples of labels
3. Acceptable evidence of GMP for medicinal materials in the form of one of:
   1. GMP Certificate
   2. Production license with confirmation that facility meets GMP
   3. CPP for pharmaceutical substances that meet GMP
   4. Certificate of conformity with European Pharmacopeia monograph (CEP)
4. Certificate of Free Sale
5. Letter of Access (if applicable)

Quality Documents

Quality documents comply with the requirements of Part II-ACTD or Part 3-ICH-CTD. However, where the manufacturer has a DMF, this is submitted in its entirety. 

1. DMF if available, or submission of the API information in the ACTD format.
2. Certificates of Analysis.

4.1.1.4 Cost and Timelines

Evaluation of the application takes a maximum of 6 months. Appraisal and issuance of certificate incur a fee of 5,500,000 VND (approx. 200 EUR/USD).

4.1.1.5 Renewal Frequency and Cost

The validity of the registration certificate is generally five years. Renewal of registration incurs a fee of 4,500,000 (approx. 165 EUR/USD).

4.1.2 Importation

4.1.2.1 Overview of Process

An establishment importing or exporting drugs or drug materials or providing the service of storage of drugs or drug materials must have a place and storehouse for drug storage, preserving tools and equipment, vehicles, quality management system, professional and technical documents, and employees satisfying the requirements of good practices of storage of drugs or drug materials.

An import permit is not required if the API is registered as above or is included in the drug registration dossier of a drug with a certificate of free sale in Vietnam.

An import declaration is made by the importer.

4.1.2.2 Documents Required from the Ingredient Supplier

1. Certificate of Free Sale from country of origin
2. CoAs

4.1.3 Change Notification

A change to the API trade name with no other changes to the ingredient would require only a notification to the DAV (do and tell process). The change is announced by the DAV on their website. There is no fee for notification.

4.2 In Pharmaceutical Products Produced by Vietnamese Manufacturers (B2C)

4.2.1 Registration of Drug Product

4.2.1.1 Registration requirements

If the APIs used have been granted registration for circulation in Vietnam as described in Section 4.1.1, there is no requirement to submit quality documentation relating to those APIs in the drug product registration. 

For unregistered APIs, ingredient quality is assessed through the drug registration evaluation process. These APIs must be declared within 15 days of the date of marketing authorization approval of the drug to be listed on the DAV website.

4.2.1.2 Registration Procedure

Applicants registering a drug product for which the API has already been registered can refer to its registration number as its quality and safety have already been assessed. Otherwise, quality documentation for the API must be submitted as part of the drug product registration.

4.2.1.3 Documents to be Provided by Ingredient Supplier

For Registered APIs

Only CoAs are required.

If API is not registered

Quality documentation requirements are as per 4.1.1.3 above.

For Excipients

CoAs are required to demonstrate compliance with quality standards.

4.2.1.4 Cost and Timelines

Drug product registration incurs a fee of 11,000,000 VND (approx. 400 EUR/USD) and takes a maximum of 12 months.

4.2.1.5 Renewal Frequency and Cost

The validity of the registration certificate is generally five years. Renewal of registration incurs a fee of 4,500,000 (approx. 165 EUR/USD).

4.2.2 Importation

Not applicable to locally manufactured products.

4.2.3 Change Notification Relating to API Trade Name Change

See Section 4.1.3 above.

4.3 As Ingredients for Health Supplements (B2B)

4.3.1 Registration

4.3.1.1 Registration Requirements

In accordance with Decree No. 15/2018/ND-CP, organizations producing or trading in health supplement active substances and excipients (food additives) must make a self-declaration of quality (declaration of conformity). For foreign manufacturers, the declaration would be made by the Vietnamese importer.

Any premixed food additives with new uses must go through the product announcement registration as described in Section 4.4.1.

4.3.1.2 Registration Procedure

1. The dossier of self-declaration is prepared, by completion of Form No. 01 (Appendix 1, 15/2018/ND-CP) in Vietnamese. Documents in a foreign language must be translated into Vietnamese and notarized.
2. The applicant must post the self-declaration documentation on mass media, their company website, or premises and submit a copy of the dossier to a competent state management agency. 
3. Immediately after self-declaration, the organization is entitled to manufacture or trade the product, taking full responsibility for its safety.

4.3.1.3 Documents Required from Ingredient Supplier

1. Certificate of Food Safety of Manufacturer
2. Demonstration of food safety through compliance of the ingredient with the relevant standard (e.g. National Standard, Codex Alimentarius). Results of testing must be issued by a designated testing laboratory or laboratory accredited with ISO 17025 and be within 12 months of the declaration date. 
3. Label

4.3.2 Importation

4.3.2.1 Overview of Process

Importers must be a registered business in Vietnam. For self-declared products, as above, an import permit is not required but the goods will be subject to a state inspection for imported food. The self-declaration dossier must be provided. 

Reduced inspection applies to consignments or items falling into one of the following cases:

1. Having been certified as meeting food safety requirements by a competent agency or organization of a country that has signed a treaty on mutual recognition in food safety inspection activities to which Vietnam is a contracting party; have inspection results of the competent authority of the exporting country for the shipment or goods in accordance with the provisions of Vietnamese law.
2. There have been 03 (three) consecutive instances within 12 months of meeting import requirements according to the normal inspection method.
3. Produced in facilities applying one of the quality management systems GMP, HACCP, ISO 22000, IFS, BRC, FSSC 22000, or equivalent.

Reduced inspection means the import dossier is only checked in 5% of the total number of imported consignments within a year. The inspection process involves only a check of the documentation. 

4.3.2.2 Documents Required from the Ingredient Supplier

1. Certificate of quality management system (GMP, HACCP, ISO 22000 or equivalent) (Certified copy)
2. Certificate of Free Sale

4.3.3 Change Notification

If there is a change of trade name, the self-declaration must be resubmitted with the new name. 

4.4 In Health Supplements Produced by Vietnamese Manufacturers (B2C)

4.4.1 Registration of Health Supplement

4.4.1.1 Registration Requirements

In accordance with Decree No. 15/2018/ND-CP Procedure, a registration of product announcement must be made for health supplements.

4.4.1.2 Registration Procedure

1. The registration dossier is prepared through the completion of Form 02 Appendix 1, 15/2018/ND-CP).
2. The dossier is submitted to the Ministry of Health.
3. If requirements are met, the product is issued with a Certificate of Registration.

4.4.1.3 Registration Documents to be Provided by Ingredient Supplier

The registration requires only a listing of the ingredients but as part of the manufacturer’s control of ingredients, the CoAs would be provided by the ingredient supplier to demonstrate compliance with the required standards.

4.4.1.4 Cost and Timelines

Evaluation is within 21 working days. Fee is 1,500,000 VND (approx. 55 EUR/USD).

4.4.2 Importation

Not applicable to locally manufactured products.

4.4.3 Change Notification

A change to the trade name of the active ingredient would have no regulatory impact on the registration of the health supplement product.

4.5 As Ingredients for Veterinary Products (B2B)

4.5.1 Registration

Registration of the ingredients is not required for use in veterinary products. 

4.5.2 Importation

4.5.2.1 Overview of the Process

In accordance with the Law on Veterinary Medicine and Circular No. 4/2015/TT-BNNPTNT, veterinary drug ingredients can be imported into Vietnam for:

1. Use in the production of veterinary drugs that have a Certificate of Sale in Vietnam;
2. Samples used for study, testing, laboratory diagnosis, or registration for sale;
3. Chemical standards in veterinary diagnosis or testing. 

The individual or organization importing the ingredients must submit an application for the import to the Department of Animal Health. Within five days, a license to import is granted if the application is successful. 

The ingredients will be required to undergo a quality inspection by the Department of Animal Health before import. Circular No. 13/2016/TT-BNNPTNT on Veterinary Drug Management states that two batches of consecutive import shipments will be sampled. If testing on these is satisfactory, the frequency of sampling will be one imported batch in five. Documentation will be checked and an inspection of the conformity of the contents of the CoA with the technical standards (e.g. pharmacopeial monograph).

4.5.2.2 Documents Required from Ingredient Supplier

The following documents are required from the ingredient supplier for an application to import:

1. Evidence of compliance with a quality management system (Good Manufacturing Practice Certificate/ISO Certificate/Equivalent Standard)
2. Certificate of Free Sale from a competent agency of the exporting country
3. Certificate of Analysis issued by the manufacturer

4.6 In Veterinary Product Produced by Vietnamese Manufacturers (B2C)

4.6.1 Registration

4.6.1.1 Overview of Process

Veterinary drugs require registration by obtaining a Certificate of Sale before supply in Vietnam. The applicant for registration must be a Vietnamese entity with an appropriate license for the manufacture or circulation of veterinary drugs.  

The registration dossier includes information on the product, its ingredients, a summary of product characteristics, labels, and product quality. Applications for new veterinary drugs require additional information on safety, pharmacology, and efficacy compared to generic drugs.

4.6.1.2 Documents Required from Ingredient Supplier

The drug product manufacturer is required to provide details of the raw materials including their specification and testing. 

In line with GMP requirements, it is the responsibility of the drug product manufacturer to control the raw materials used. However, if the ingredient supplier certificate of analysis is used to demonstrate compliance with some aspects of the specification, this would need to be provided by the ingredient supplier. 

4.6.1.3 Cost and Timeframes

The application is evaluated within six months of receipt. The cost of a registration certificate is 1,350,000 VND (approx. 50 EUR/USD).

4.6.1.4 Renewal Frequency and Cost

A Certificate of Sale is valid for five years. Re-registration incurs a fee of 350,000 VND (approx. 13 EUR/USD).

4.6.2 Importation

Not applicable to locally manufactured products.

4.6.3 Change Notification

A change to the API trade name would have no regulatory impact. 

4.7 References

1. Law on Pharmacy 2016 (Law 105/2016/QH13)

https://faolex.fao.org/docs/pdf/vie178850.pdf

2. Regulations on Registration of Circulation of Drugs and Medicinal Ingredients Number 08/2022/TT-BYT

https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-08-2022-TT-BYT-dang-ky-luu-hanh-thuoc-nguyen-lieu-lam-thuoc-528590.aspx

3. Announcement of fees in the field of Pharmaceuticals and Cosmetics August 2023 https://lawnet.vn/thong-tin-phap-luat/en/thong-bao-van-ban-moi/announcement-of-fees-in-the-field-of-pharmaceuticals-and-cosmetics-as-of-august-1-2023-in-vietnam-131096.html

4. Decree No. 15/2018/ND-CP Details Implementing Some Articles of the Food Safety Law (English Translation)

https://www.mpi.govt.nz/dmsdocument/42303-Food-Safety-requirements-for-imported-food-Decree-152018ND-CP

5. Circular No. 04/2015/TT-BNNPTNT on Guidelines for the Decree No. 187/2013/ND-CP Dated November 20, 2013 of the Government on Guidance on the Law on Commerce on Internation Trade in Good and Commercial Agency, Trading, Processing and Transit of Goods with Foreign Countries in the Agriculture, Forestry and Aquaculture Fields

https://faolex.fao.org/docs/pdf/vie170802.pdf

6. Decree No. 33/2005/ND-CP of March 15, 2005 Detailing the Implementation of a Number of Articles of the Ordinance on Veterinary Medicine

https://faolex.fao.org/docs/pdf/vie52438.pdf

7. Circular No. 13/2016/TT-BNNPTNT on Veterinary Drug Management

https://faolex.fao.org/docs/pdf/vie223725.pdf