Decision 40/2008/QD-BYT delegates national administration of cosmetics produced in Vietnam to provincial and municipal health departments. These departments will perform functions of announcing, advertising, and post-market surveillance of cosmetics.
适用范围
Provincial and municipal health departments
要点
- Provincial and municipal health departments → receive and process applications for announcing cosmetic products, issue registration numbers for announcement certificates of cosmetic products, and collect fees as prescribed.
- Provincial and municipal health departments → receive and handle applications for registering advertisements of cosmetic products.
- Provincial and municipal health departments → report monthly lists of cosmetic products that have been issued registration numbers for announcement certificates of cosmetic products to the Ministry of Health.
- Provincial and municipal health departments → conduct inspections and post-market surveillance of cosmetic products within their jurisdiction.
- Provincial and municipal health departments → announce recalls of substandard quality cosmetic products and handle violations according to regulations.
🌐 本文件的社会影响
- Positive impact: Reduces administrative burden for domestic cosmetic manufacturing enterprises.
- Negative impact: Increases the management responsibility of provincial and municipal health departments in inspecting and supervising post-market cosmetic products.
❓ 常见问题
What tasks must the health departments undertake?
Provincial and municipal health departments must receive and process applications for announcing cosmetic products, register advertisements for cosmetic products, and report monthly lists of cosmetic products that have been issued registration numbers for announcement certificates of cosmetic products to the Ministry of Health.
Does the health department charge fees when issuing registration numbers for announcement certificates of cosmetic products?
Yes, the health department will collect fees as prescribed in Decision No. 59/2008/QD-BTC dated July 21, 2008, of the Minister of Finance.
What responsibilities does the health department have in inspecting and supervising post-market cosmetic products?
Provincial and municipal health departments will conduct inspections and post-market surveillance of cosmetic products within their jurisdiction.
What is the duration of effectiveness of this Decision?
This Decision takes effect 90 days from the date of publication in the Official Gazette.
How should the health department submit reports on lists of cosmetic products?
Monthly reports should be submitted before the 15th day of the following month, with the quantity and form of submission including: 01 copy via email (email address: [email protected]); 01 copy via official correspondence (address: Drug Administration - Ministry of Health - 138A Giang Vo Street, Hanoi).
全文
Pursuant to …;
Delegation of State Management Authority over Cosmetics Produced in Vietnam
____________________________________
THE MINISTER OF HEALTH
Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to the Law on Product and Goods Quality 2007;
To implement Resolution No. 08/2004/NQ-CP dated June 30, 2004 of the Government on further promoting the delegation of state management authority between the Government and provincial-level city authorities;
Considering the proposal of the Director of the Drug Administration Department,
DECISION:
Article 1. The Ministry of Health delegates to the Health Departments of provinces and centrally governed cities the function of managing state authority over cosmetics produced in Vietnam.
Article 2. The Health Departments of provinces and centrally governed cities shall be responsible for implementing regulations on managing domestically produced cosmetics as stipulated in Decision No. 48/2007/QĐ-BYT dated December 31, 2007 of the Minister of Health on the Regulation on Managing Cosmetics with specific contents as follows:
1. Receiving and processing applications for declaration and re-declaration of cosmetic products, issuing registration numbers for declaration forms of cosmetic products, and collecting fees according to Decision No. 59/2008/QĐ-BTC dated July 21, 2008 of the Minister of Finance amending and supplementing Decision No. 44/2005/QĐ-BTC dated July 12, 2005 of the Minister of Finance on the system of collection, payment, management, and utilization of fees for business trade licensing, standard and condition assessment fees for medical and pharmaceutical professions, and fees for issuing export and import permits and certificates of practice for medical and pharmaceutical professions.
Cosmetic products produced in Vietnam that have been issued Declaration Forms for Quality Standards by the Drug Administration Department or registration numbers for Declaration Forms for cosmetic products will continue to be produced within their validity period; upon expiration, they must be re-declared at the local Health Department (where the cosmetic production facility is located).
Regulations on recording registration numbers for Declaration Forms for cosmetic products: serial number issued + forward slash + year of issuance (last two digits) + forward slash + CBMP + hyphen + abbreviation of the province or city name according to Model No. 1 attached hereto.
Example: 234/08/CBMP-HN means the registration number for the Declaration Form for cosmetic products issued by the Hanoi Health Department in 2008, with serial number 234.
2. Receiving and processing applications for advertising registration of cosmetic products; receiving and processing applications for organizing seminars/events to introduce cosmetic products (excluding advertising methods implemented according to Circular Joint No. 06/2007/TTLT/BVHTT-BYT-BNN-BXD dated February 28, 2007 of the Ministry of Culture, Sports and Tourism, the Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Construction on guiding procedures for unified single-window business trade licensing).
3. Reporting monthly to the Ministry of Health (Drug Administration Department) a list of cosmetic products that have been issued registration numbers for Declaration Forms for cosmetic products according to Model No. 2 attached hereto (monthly reports sent before the 15th day of the following month).
Quantity and form of report submission: 01 copy via email (email address: [email protected]); 01 copy via official communication (address: Drug Administration Department - Ministry of Health - 138A Giang Vo Street, Hanoi City).
4. Implementing post-market inspection and supervision of cosmetic products within their jurisdiction.
5. Implementing announcements from the Drug Administration Department regarding the recall of non-compliant cosmetic products. Handling violations according to current regulations. Reporting the recall and handling of violations to the Drug Administration Department.
Article 3. This Decision takes effect ninety days from the date of publication in the Official Gazette.
Article 4. The Heads of the Ministry's Office, the Inspector General of the Ministry of Health, the Director of the Drug Administration Department, heads of units under the Ministry, Directors of Health Departments of provinces and centrally governed cities, and heads of health sector units are responsible for enforcing this Decision./.
DEPUTY MINISTER
原始文件（PDF）
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