VIETNAM COSMETICS REGULATORY AUTHORITIES . VIETNAM COSMETICS REGULATORY AUTHORITIES Nguyen Thanh Van – Drug Administration of Vietnam

VIETNAM COSMETICS REGULATORY AUTHORITIES ASEAN COSMETIC DIRECTIVE Circular No 06/2011/TT-BYT dated 25th January 2011 of Ministry of Heath regulations on cosmetics manager Decision No 10/2010/QD-TTg dated 10th September 2010 of President on Certificate of Free Sale of products

. CIRCULAR No 06/2011/TT-BYT dated 25th January 2011 of Ministry of Heath regulations on cosmetics manager

Definition of Cosmetic Product A “cosmetic product” shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.

Safety Requirements 1. A cosmetic product placed on the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product’s presentation, its labeling, instructions for its use and disposal, warning statements as well as any other indication or information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the market. 2. The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down.

Documents to be submitted with a product notification Company responsible for placing the cosmetic product in the market have to notify with authorities before importing or manufacturing, Notification files contain: Notification form with full ingredient listing and the percentage of restricted ingredients appearing in the annexes of the ASEAN Cosmetic Directive and other infomations (PL No 01); Copy of the Business Licence of registrant or company responsible for placing the product in the market; Letter of the authorisation from the product owner or manufacturer (only apply to imported cosmetic); Certificate of Free Sale - CFS

PL No 01 The company responsible for placing the cosmetic product in the market have to submit the information about the product on the Template for Notification of Cosmetic Product, such as: Name of product (include it’s brand). Product type (make up, perfume, hair care, etc). Intended use. Product presentation. Particulars of manufacturer. Particulars of local company responsible for placing the cosmetic product in the market. Product ingredient list

Ingredient Listings Cosmetic Products have to be adopt all Annex: Annex II – List of substances which must not form part of the composition of cosmetic products Annex III – List of substances which cosmetic products must not contain except subject to restrictions and condition laid down Annex IV - List of colouring agents allowed for use in cosmetic products Annex VI – List of preservatives allowed Annex VII – List of UV filters which cosmetic products may contain

PRODUCT INFORMATION FILE- PIF Must be at the address of the Company responsible for placing the product in the market; PIF must be in the local language or English; Must be kept updated of all modifications;

PRODUCT INFORMATION FILE- PIF Part 1: Administrative documents and product summary: allways available Part 2: Quality data of raw materials; Part 3: Quality data of finished products; Part 4: Safety and efficacy data; Part 2,3,4 can be performed later (but not more than 60 days later).

Post-Market Surveillance Authorities has been deploying Post-Market Surveillance, collaborates with the National Institute for Drug Quality Control, Health Inspectorate, Market Control Department to go for audit. High-risk cosmetic products have been selected for priority audit. Authorities coordinates with the customs and other relevant authorities to prevent cosmetic products illegally imported into Viet Nam. Authorities can audit the PIF, Product quality, GMP, Labeling, etc.

COSMETIC LABELLING REQUIREMENT 1. The following particulars shall appear on the outer packaging of cosmetic products or, where there is no outer packaging, on the immediate packaging of cosmetic products. 1.1. The name of the cosmetic products and its function, unless it is clear from the presentation of the product. Name of the product on the original label must in Latin language. 1.2. Instructions on the use of the cosmetic products, unless it is clear from the product name or presentation;

COSMETIC LABELLING REQUIREMENT 1.3. Full ingredient listing. The ingredients shall be specified by using the nomenclature from the latest edition of standard references. Botanicals and extract of botanicals should be identified by its genus and species. The genus may be abbreviated; The following shall not, however, be regarded as ingredients; - Impurities in the raw materials used; - Subsidiary technical materials used in the preparation but not present in the final product; - Materials used in strictly necessary quantities as solvents, or as carriers for perfume and aromatic compositions.

COSMETIC LABELLING REQUIREMENT 1.4. Country of manufacture. 1.5. The name and address of the company or person responsible for placing the product on the local market. 1.6. The contents given by weight or volume, in either metric or both in metric and imperials system. 1.7. The manufacturer’s batch number. 1.8. The manufacturing date or expiry date of the product in clear terms (e.g. month/year).

COSMETIC LABELLING REQUIREMENT 2. In cases where the size, shape or nature of the container or package does not permit the particulars laid down in para 1 (a) – (i) to be displayed, the use of leaflets, pamphlets, hang tags, display panel, shrink wrap etc. shall be allowed. However, the following particulars at least shall appear on small immediate packaging: 2.1. the name of the cosmetic products; 2.2. the manufacturer’s batch number

MANUFACTURING Cosmetic product are consistently manufactured and controlled to the specified quality, compliance with CGMP- ASEAN Guidelines. It is concerned with all aspects of production and quality control.

. DECISION No 10/2010/QD-TTg dated 10th September 2010 of President on Certificate of Free Sale of products

Certificate of Free Sale Regulatory Authority to issue: State management agency. Legalized by Vietnamese Embasy in local country. Contents: Name of issuer. Date and reference number. Name of product. Kind of product. Name and address of manufacturer. Name, signature and seal. CFS must be show that the product is freely sole in the market of the manufacturing country.

Thank you for your attention !