Decision No. 964/QLD-QĐ promulgates temporary regulations on the management of cosmetic quality directly affecting human health.

 Pursuant to …;

Issuing temporary regulations on the quality management of cosmetics directly affecting human health

直接影响人类健康

DIRECTOR OF THE VIETNAM DRUG MANAGEMENT AGENCY

Pursuant to Decree No. 86-CP dated December 8, 1995 on the division of responsibilities for state management of product quality.

Pursuant to Circular No. 07/TTLB dated July 1, 1996 issued jointly by the Ministry of Health, the Ministry of Science, Technology and Environment guiding the implementation of Decree No. 86/CP dated December 8, 1995 on the division of responsibilities for state management of product quality.

Pursuant to Decision No. 547/TTg dated August 13, 1996 of the Prime Minister establishing the Vietnam Drug Management Agency under the Ministry of Health.

Pursuant to Decision No. 2063/BYT-QĐ dated November 4, 1996 of the Minister of Health promulgating the list of cosmetic products required to register their quality with the Ministry of Health.

Based on the proposal of the Registration Department of Drugs and Cosmetics under the Quality Control Department.

Pursuant to …;

Article 1. Attached herewith are the temporary regulations on the quality management of cosmetics directly affecting human health.

Article 2. All cosmetics directly affecting human health listed in the Ministry of Health's regulations, whether produced domestically or imported, must comply with the registration requirements stipulated in Article 1 if they wish to be circulated in Vietnam.

Article 3. This Decision shall take effect from January 1, 1997.

Article 4. Heads of departments under the Vietnam Drug Management Agency, Directors of Provincial Health Services, and heads of units producing, trading, exporting, and importing cosmetics directly affecting human health are responsible for implementing this Decision.

 

 

TEMPORARY PROVISIONS

QUALITY MANAGEMENT OF COSMETICS DIRECTLY AFFECTING HUMAN HEALTH
(Issued pursuant to Decision No. 964/QLD-QĐ dated December 27, 1996)

The cosmetics referred to in these regulations are those directly affecting human health included in the list of products required to register their quality with the Ministry of Health (referred to as cosmetics).

A. REGISTRATION OF QUALITY FOR COSMETICS DIRECTLY AFFECTING HUMAN HEALTH:

1- Domestic enterprises, individuals, and units with foreign investment (referred to as establishments) producing and trading in Vietnam the types of cosmetics listed in the "List of Cosmetic Products Required to Register Their Quality at the Ministry of Health" must submit quality registration files as prescribed to the Vietnam Drug Management Agency.

The quality registration file is a technical legal document that establishments must follow during production and trade; it serves as a legal basis for inspecting and testing product quality, resolving complaints and accusations regarding product quality, and economic disputes between producers and customers. Establishments must attach test reports with each batch of goods shipped out.

The registration number is valid for two years from the date of issuance. Six months before the expiration of the registration number, if the establishment wishes to continue production, it must resubmit a new registration file.

2- Regulations on quality standards.

Establishments registering quality standards for cosmetics may apply Vietnamese standards, national standards of other countries, or enterprise standards but must not be lower than Vietnamese standards (if available); they must have quality indicators for each type of product to ensure hygiene and safety of cosmetics.

All types of cosmetics must meet mandatory quality indicators ensuring they do not cause harmful effects on the human body such as skin irritation, allergic reactions, or the appearance of blisters, which must be specified in the quality standards.

3- Cosmetics registered for quality by the Ministry of Health must circulate in the market according to the approved technical dossier and must print the registration number on the label.

Establishments can only circulate cosmetics that have been tested and confirmed to meet the registered quality. Expired cosmetics cannot be circulated.

During circulation in the market, producers, traders, and importers are responsible for the quality of their cosmetics and any adverse events caused by them, including economic losses.

4- During the validity period of the quality registration number for cosmetics:

4.1- If there is a change in the name of the cosmetic or brand name or packaging style, the following must be submitted:

- Application for change.

- Samples of the new label and product for the change.

- Search results for the brand name at the National Office of Intellectual Property, Ministry of Science, Technology and Environment for domestic cosmetics; permission from the home country for the change for imported cosmetics (if applicable).

4.2- Any other changes must be registered anew according to the prescribed procedures.

5- Cosmetics applying for quality registration must not violate Vietnam's intellectual property regulations or international conventions to which Vietnam is a party.

6- The quality registration application must be made in three copies, at least one of which must be an original or certified copy; the application must be in Vietnamese for domestic production; Vietnamese or English for foreign production, securely bound to prevent loss, with clear printing without erasures, presented on A4 paper size.

7- Cosmetics listed in the regulations requiring registration with the Ministry of Health, which were previously granted a quality registration number or import permit by the competent authority, may continue to circulate with the old registration number or permit until its expiration. (However, to provide a basis for quality inspection of these cosmetics, establishments must submit to the Vietnam Drug Management Agency no later than the first quarter of 1997: a list of cosmetics permitted to circulate in Vietnam along with the standards for quality inspection.) After this period, if the establishment wishes to re-register the quality, it must proceed according to the Ministry of Health's regulations.

8- Establishments applying for quality registration of cosmetics must pay the registration fee as prescribed.

REGULATIONS ON QUALITY REGISTRATION FILES FOR COSMETICS

I. QUALITY REGISTRATION FILE FOR DOMESTICALLY PRODUCED COSMETICS

1- Application for registration: Form 1.

2- Product quality standards: as per Point 2 of Part A.

3- Test report: Issued by the Institute of Testing or Branch Institute of Testing.

4- Formula description:

- Scientific name of each ingredient.

- Quantity of ingredients in the formula for one unit of packaging.

- Standards for each component.

- Function and mechanism of action of the product.

5- Label model: must include the following contents:

- Product name.

- Name and address of the production facility.

- Product form.

- Formula.

- Packaging specifications: weight, volume, quantity of cosmetics in one unit of packaging.

- Registration number (RN - issued by the Department of Quality Control), control number (CN), expiration date (ED).

- Uses, usage instructions, precautions (if applicable).

- Storage conditions.

The above contents must be presented in Vietnamese; if in foreign languages, they must be smaller than the Vietnamese text.

6- Product samples: three samples.

7- Other related documents: if any.

II- QUALITY REGISTRATION FILE FOR FOREIGN COSMETICS

1- Application for registration: form 2.

2- Certificate of quality registration: issued by the competent authority of the country of origin (country with the production facility).

3- Standards and product quality: as specified in point 2 of part A.

4- Test report: Test report from the quality control laboratory of the production facility or issued by the national quality control agency of the country of origin.

5- Formula description:

- Scientific name of each ingredient.

- Quantity of each ingredient in the formula of one unit of packaging.

- Standards for each component.

- Function and mechanism of action of the product.

6- Label model: must be the officially circulated label in the country of origin, but it must also include an English or Vietnamese translation (Note: clearly indicate the country of production; ensure necessary information as required for domestic cosmetic labels).

7- Product samples: three samples.

8- Other related documents: if any.

III- QUALITY REGISTRATION FILE FOR COSMETICS PRODUCED BY FOREIGN ENTERPRISES OR JOINT VENTURES WITH INVESTMENT LICENSES IN VIETNAM

1- Application for registration: form 3.

2- Investment license: copy.

3- Standards and product quality: as specified in point 2 of part A.

4- Test report: Issued by the Institute of Testing or Branch Institute of Testing.

5- Formula description:

- Scientific name of each ingredient.

- Quantity of ingredients in the formula for one unit of packaging.

- Standards for each component.

- Function and mechanism of action of the product.

6- Label model: Must include the following contents:

- Product name.

- Name and address of the production facility.

- Product form.

- Formula.

- Packaging specifications: weight, volume, quantity of cosmetics in one unit of packaging.

- Registration number (RN), control number (CN), expiration date (ED).

- Uses, usage instructions, precautions (if applicable).

- Storage conditions.

The above contents must be in Vietnamese; if in foreign languages, they must be smaller than the Vietnamese text for domestic product labels; for export product labels, the contents can be in English (for export only).

6- Product samples: three samples.

7- Other documents: if any.

IV- QUALITY REGISTRATION FILE FOR LICENSED MANUFACTURED COSMETICS:

Licensed manufacturing is only carried out for products that have been legally circulating in Vietnam or abroad with licensed facilities. The file must be submitted in Vietnamese.

1- Application for registration: form 4.

2- Certificate of quality registration for licensed cosmetics issued by the competent authority in Vietnam or the country of origin to the licensed facility.

3- Quality standards and testing methods: the standard of the licensed facility.

4- Test report: Issued by the Institute of Testing or Branch Institute of Testing.

5- Formula description:

- Scientific name of each ingredient.

- Quantity of each ingredient in the formula of one unit of packaging.

- Standards for each component.

- Function and mechanism of action of the product.

7- Label model: must be the label of the licensed facility. It must include the uses and usage instructions in Vietnamese. The name and address of the licensed facility must be clearly indicated. For export purposes, it may be in English (for export only).

8- Product samples: three samples.

9- Other documents: if any.

V- PROCEDURE FOR ISSUING QUALITY REGISTRATION NUMBER

Upon receipt of a valid application, the Department of Drug Management of Vietnam will respond within six months from the date of receipt of the application.

1- If eligible for issuance of a quality registration number:

- Decision to issue the list of items granted a quality registration number.

- Within 45 days after receiving the registration number, the production facility must submit three samples of officially registered product labels (for domestic production facilities). Then, issue a certificate of quality registration.

2- If not eligible for issuance of a quality registration number: the issuing authority will inform the applicant that the number will not be issued, or that the application is incomplete and specify the reasons.

3- In cases where there is a request for inspection by the quality control agency, the applicant must submit samples and fees according to current regulations.

B. REGULATIONS ON EXPORT AND IMPORT OF COSMETIC RAW MATERIALS DIRECTLY IMPACTING HUMAN HEALTH

1- Ministry of Health (Department of Drug Management of Vietnam) reviews the list of export and import of cosmetic raw materials.

2- Only domestic enterprises with trading and direct import/export functions may apply for export and import of cosmetics.

3- Procedure for applying for permission to export and import cosmetics:

- Step 1: Enterprises must prepare an application (as stipulated in point 4 of this section) for review by the Department of Drug Management of Vietnam.

- Step 2: Based on the approval of the Department of Drug Management of Vietnam, enterprises process export and import procedures with the General Customs Department or relevant agencies according to current regulations.

4- Procedure for applying for import of cosmetics at the Department of Drug Management of Vietnam:

I- Cosmetics registered with a quality registration number by the Ministry of Health of Vietnam: Only cosmetic items registered with a quality registration number by the Department of Drug Management of Vietnam or as specified in point 7 of part A can be imported for circulation in Vietnam. The application file includes:

- Application form (form 5).

- List of imported cosmetic items (form 6).

II- Cosmetics not registered with a quality registration number by the Department of Drug Management of Vietnam are not allowed to be imported for circulation in Vietnam. These items can only be brought into Vietnam for the purpose of participating in trade fairs and exhibitions in Vietnam to understand the market and obtain samples for quality registration. The quantities are limited (depending on specific circumstances, the Department of Drug Management of Vietnam will consider). The application file includes:

- Application form: (form 7).

- List of items requested for import (form 8).

5- Only cosmetic items registered with a quality registration number by the Department of Drug Management of Vietnam or as specified in point 7 of part A can be exported for sale abroad. The application file is based on the regulations of the exporting country.

III- Regulations on the quality of imported cosmetics:

- Imported cosmetics must have original quality test reports accompanying each batch.

- Cosmetic products imported into Vietnam must be inspected for quality by the State Quality Inspection Agency (the Institute of Quality Inspection, Branch Institutes of Quality Inspection, or other agencies designated) according to the standards registered in Vietnam and certified to meet the standards before being put into circulation. To avoid potential losses, enterprises may base their import orders on approved import orders, sending samples to the State Quality Inspection Agency for pre-import quality inspection.

C. DISTRIBUTION AND CIRCULATION OF COSMETICS AFFECTING HUMAN HEALTH DIRECTLY

Cosmetics may be sold in pharmaceutical business establishments or commercial establishments, department stores of state organizations, collectives, or individuals, but they must have a dedicated area for cosmetics that meets the storage and hygiene conditions specified by the manufacturer. The area must be sufficient to conduct business operations.

D. INSPECTION AND QUALITY CONTROL WORK

1- The Department of Medicine Management of Vietnam, the Ministry of Health Inspectorate shall cooperate with the Market Management Department to organize inspections and checks on the implementation of cosmetic quality management regulations by establishments nationwide. The Health Departments, Health Department Inspectors, Pharmaceutical Affairs Departments shall cooperate with the Market Management Sub-departments to organize inspections within their respective jurisdictions.

The Department of Medicine Management of Vietnam, quality control agencies (Institute of Quality Inspection, Branch Institutes of Quality Inspection), health stations, and health centers under provincial and centrally-administered city Health Departments have the authority to take samples from the market according to the current drug sampling regulations and send them to quality control agencies for inspection. Upon receiving results, they must be sent to the manufacturing establishment, the location where the sample was taken, and relevant authorities.

Establishments must comply and provide all favorable conditions for inspections, sampling, and quality testing at their premises.

2- Suspension of circulation of cosmetics in the market in the following cases:

Batches of cosmetics do not meet the requirements as approved in the registration dossier.

3- Revocation of registration in the following cases: The same product has violated three or more times as stipulated in point 2 of this section.

4- The Department of Medicine Management of Vietnam is the agency issuing the Decision to suspend circulation and revoke registration for cosmetic quality.

5- Manufacturing establishments circulating such products must thoroughly and promptly recall batches that do not meet quality standards and are suspended, bear full responsibility for material compensation caused by the circulation of substandard cosmetics, and report to the Department of Medicine Management of Vietnam and relevant authorities.

The Department of Medicine Management of Vietnam will notify units concerned and request compliance. Any establishment violating the regulations will be subject to legal sanctions depending on the severity of the violation.