Vietnam: What is the validity of a cosmetic product proclamation report? Is it required to make a proclamation again after expiry? What does the cosmetic proclamation dossier include?
What is the validity of a cosmetic product proclamation report in Vietnam? Is it required to make a proclamation again after expiry?
First of all, the receipt number of cosmetic product proclamation report is explained according to the provisions of Clause 4 Article 2 of Circular 06/2011/TT-BYT as follows:
Term Interpretation
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4. The receipt number of Cosmetic product proclamation is a number issued by the competent state management agency, when receiving the cosmetic product announcement dossier. The announcement receipt number is useful in order to prove cosmetic product have been declared by organizations, individuals who are responsible for circulation products in market, just about cosmetic shall be circulated in market, are not value to certify that such product have been guaranteed of the safety, the effectiveness, and meeting all requirements of the ASEAN Cosmetic Association and the Annexes attached.
The receipt number of a cosmetic product proclamation report is a number issued by the competent state management agency when receiving the cosmetic product announcement dossier and is useful in order to prove cosmetic products have been declared by organizations, individuals who are responsible for circulating products in the market.
Regarding the validity of a cosmetic product proclamation report is specified in Article 10 of Circular 06/2011/TT-BYT as follows:
The effect time of the receipt number of cosmetic product proclamation report
The receipt number of the cosmetic product proclamation report shall be valid for 05 years since issuing day. After 05-year-expiry, if organizations or individuals want to continue selling products in the market, they must make a proclamation again before the expiry of the receipt number of cosmetic product proclamation report and pay a regulated cost fee.
Thus, the validity of a cosmetic product proclamation report is 05 years from the date of issue.
After 05-year-expiry, if organizations or individuals want to continue selling products in the market, they must make a proclamation again before the expiry of the receipt number of cosmetic product proclamation report and pay a regulated cost fee.
What does the cosmetic proclamation dossier in Vietnam include?
According to the provisions of Article 4 of Circular 06/2011/TT-BYT (some regulations are abolished Point a Clause 2 Article 12 of Decree 155/2018/ND-CP and amended Point a Clause 1 Article 1 of Circular 29/2020/TT-BYT), the cosmetic proclamation dossier includes:
- Cosmetic product proclamation report (02 versions) with the proclamation data (soft version of proclamation report);
- Original or notarized copy of letter of attorney from the producers or the owners of products authorized for organizations, individuals are responsible for putting products on the market in Vietnam (applied to the import or domestic cosmetic of which organizations or individuals are responsible of putting products on the market, be not the manufacturer).
For the import product, the letter of attorney must be a copy notarized sign and consul legalized as provisions of law, except for being exempted from the consul legalization in regard to international treaties in which Vietnam is a member. The letter of attorney must satisfy requirements regulated at the Article 6 of this Circular.
- Except for the cases of CFS exemption, the application for notification of imported cosmetic products shall have a CFS that satisfies the following requirements:
+ The CFS is still effective and issued by a competent authority of the country or origin or exporting country (original copy or authenticated copy).
+ In case the CFS does not have an expiration date, it must be issued within the last 24 months;
- The CFS is consularly legalized as prescribed by law, unless:
++ Consular legalization is exempt under an international treaty to which Vietnam is a signatory or under principle of reciprocity between Vietnam and the issuing country;
++ The issuing authority or a diplomatic authority sends a physical document or email to Drug Administration of Vietnam to certify the CFS;
+ The CFS contains at least the information specified in Article 36 of the Law on Foreign Trade Management and Clause 3 Article 10 of the Government's Decree No. 69/2018/ND-CP
What are the regulations on preparing the cosmetic product proclamation report in Vietnam?
According to the provisions of Points a and b, Clause 1, Article 5 of Circular 06/2011/TT-BYT as follows:
- The cosmetic product report is set up in accordance with the form in appendix No 01-MP. The proclamation report must be signed by the representative under laws and with the seal of the organizations or individuals who are responsible for selling products in the market at the positions of the report's paper margins. The manner to write contents in the cosmetic product report shall followed the instruction in the appendix No 02-MP
- Every cosmetic product proclaimed in a proclamation report.
Cosmetic products which are perfectly produced in every different enterprise shall be proclaimed separately. In case there are more than one company, taking part in the manufacturing process in order to produce a complete product, may jointly make a proclamation report and clearly state each companies’ name and full address.
Products have the same owners in one of the following situations is permitted to proclaim in one proclamation report:
+ Products are packed with a joint name and sold out in the form of a product set.
+ Products have the same name, same product line with similar formulas but different in color or smell. For products of hair dye, perfume, must be separately proclaimed with each color, each smell.
+ Other kinds will be decided by the department of Medicine management – the Health Ministry based on the ASEAN Cosmetic Association’s decision.
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