THE MINISTRY OF HEALTH THE SOCIALIST REPUBLIC OF VIETNAM ------- Independence - Freedom - Happiness --------------- No. 09/2015/TT-BYT Hanoi, May 25, 2015 CIRCULAR STIPULATING THE APPROVAL FOR CONTENTS OF ADVERTISEMENTS FOR SPECIAL PRODUCTS, COMMODITIES AND SERVICES UNDER THE AUTHORITY OF THE MINISTRY OF HEALTH Pursuant to the Law on Advertising dated June 21, 2012; Pursuant to the Law on Food Safety dated June 17, 2010; Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009; Pursuant to the Law on Chemicals dated November 21, 2007; Pursuant to the Law on Pharmacy dated June 14, 2005; Pursuant to the Government’s Decree No. 181/2013/NĐ-CP dated November 14, 2013 on providing specific provisions on implementation of several articles of the Law on Advertising; Pursuant to the Government’s Decree No. 100/2014/NĐ-CP dated November 6, 2014 on providing regulations on trading and consumption of infant nutritional products, feeding bottles and artificial nipples; Pursuant to the Government’s Decree No. 63/2012/NĐ-CP dated August 31, 2012 on defining the functions, tasks, powers and organizational structure of the Ministry of Health; After considering the request of the Director of the Department of Legal Affairs; The Minister of Health hereby promulgates the Circular on the approval for contents of advertisements for special products, commodities and services under the authority of the Ministry of Health. Chapter I GENERAL PROVISIONS Article 1. Scope of application This Circular stipulates requirements, authority to decide, necessary documentation submitted to apply for and procedures for approval for contents of advertisements for special products, commodities and services under the authority of the Ministry of Health which include: 1. Pharmaceutical products which are not prohibited from being advertised as stipulated in Clause 5 Article 7 of the Law on Advertising. 2. Cosmetic products. 3. Food, food additives under the delegated authority of the Ministry of Health, including: a) Functional foods b) Micronutrient-fortified foods c) Natural mineral water; d) Bottled drinking water; dd) Food additives or food processing aids 4. Chemicals, pesticide products, disinfectants or sanitizers used in household appliance and health care industry. 5. Medical equipment. 6. Baby milk and nutritional products under the authority of the Ministry of Health which are not subject to the advertising ban stipulated in Clause 1 Article 7 of the Law on Advertising. 7. Health care services. Article 2. Applicable entities This Circular shall apply to organizations or individuals engaged in approval for contents of advertisements for special products, commodities and services under the authority of the Ministry of Health throughout Vietnam. Article 3. Examination cost, fee for issuance and reissuance of the written approval for contents of advertisements for special products, commodities and services under the authority of the Ministry of Health 1. The applicant for approval for advertisement contents shall be liable for the examination cost, fee for issuance or reissuance of advertisement contents at the competent authority that receives the application for advertisement contents in accordance with laws. 2. While filing an application for approval for the content of an advertisement, advertisement examination cost and approval fee must be paid as follows: a) The followings shall be considered as one application for approval for advertisement contents, including: - An advertisement for a product, commodity or service that target a particular group of customers; - An advertisement for a product, commodity or service that targets a particular group of customers and takes different advertisement forms such as fliers, banners, books or newspapers, etc. b) The followings shall not be considered as one application for approval for advertisement contents, including: - Different advertisements for a product, commodity or service that target a particular group of customers. In this case, each advertisement shall be considered as an application for approval for advertisement contents; - An advertisement conveying a product, commodity or service to a particular group of customers. In this case, each product, commodity or service shall be considered as an application for approval for advertisement contents; c) Advertising of pharmaceutical products: The followings shall be considered as one application for approval for pharmaceutical advertisement contents, including: - Cases governed by regulations laid down in Point a Clause 2 of this Article; - An advertisement for a pharmaceutical product with one content or one dosage form that target a particular group of customers; - An advertisement for two or multiple pharmaceutical products with the same active ingredient, and different contents, dosage forms or administration which are produced by the same manufacturer and target a particular group of customers. d) Advertising of cosmetic products: a) The followings shall be considered as one application for approval for cosmetic advertisement contents, including: - Cases governed by regulations laid down in Point a Clause 2 of this Article; - One advertisement for two or multiple products together with one notification of the cosmetic products with the receiving number dd) Food or food additives: - The followings shall be considered as one application for approval for food or food additive advertisement contents, including: + Cases governed by regulations laid down in Point a Clause 2 of this Article; + An advertisement for two or multiple food or food additive products which have the same effect and target a particular group of customers. - The followings shall be considered as one application for approval for food or food additive advertisement contents, including: + Cases governed by regulations laid down in Point b Clause 2 of this Article; + An advertisement for two or multiple food or food additive products which have the same effects and target different groups of customers. In this case, each product shall be considered as an application for approval for advertisement contents. Chapter II REQUIREMENTS, AUTHORITY TO DECIDE, NECESSARY DOCUMENTATION SUBMITTED TO APPLY FOR AND PROCEDURES FOR APPROVAL FOR CONTENTS OF ADVERTISEMENTS FOR SPECIAL PRODUCTS, COMMODITIES AND SERVICES UNDER THE AUTHORITY OF THE MINISTRY OF HEALTH Article 4. General requirements for grant of approval for an advertisement content 1. The advertisement content must conform to legal regulations on advertising and none of prohibited acts stipulated in Article 8 of the Law on Advertising is committed. 2. Voices, wording and pictures used in an advertisement must be concise, common and conform to regulations laid down in Article 18 of the Law on Advertising. The smallest size of the font used in an advertisement content must be large enough to be read in a normal condition and is not smaller than the size proportional to the size of Vntime font or the 12-point size of Times New Roman font printed on the A4-size paper. Article 5. Requirements for grant of approval for a pharmaceutical advertisement content Pharmaceutical products must meet requirements for being advertised as stipulated in Point a Clause 4 Article 20 of the Law on Advertising, and conform to the regulations laid down in Article 3 of the Government's Decree No. 181/2013/NĐ-CP on providing specific regulations on implementation of several articles of the Law on Advertising (hereinafter referred to as the Decree No. 181/2013/NĐ-CP) as well as the following specific provisions: 1. Pharmaceutical products permitted to be advertised in accordance with Clause 1 Article 1 hereof shall include: a) Pharmaceutical products specified in the list of over-the-counter medicines and not subject to the competent authority’s warning of restricted use or permitted use under the doctor’s medical supervision; b) With regard to advertising of pharmaceutical products through audio and video news, such products must contain main active ingredients in the list of medicinal active ingredients and herbal materials permitted to be advertised through audio and video news as stipulated in the Appendix No. 02 enclosed herewith. 2. Pharmaceutical products have been accredited by numerical codes of free circulation in Vietnam which remain valid and instructional leaflets which have been approved by the Ministry of Health. 3. All necessary documents must be submitted as stipulated in Article 14 hereof. 4. The applicant for approval for advertisement contents is the organization that signs its name on the registration certificate of free circulation for products, or the Vietnam representative office of the organization that signs its name on the registration certificate of free circulation for products, or the organization with its legal standing authorized in writing by the organization that signs its name on the registration certificate of free circulation for products. 5. Contents of advertisements for pharmaceutical products must conform to the following regulations: a) Be consistent with documents stipulated in Clause 1 Article 3 of the Decree No. 181/2013/NĐ-CP; b) Provide sufficient information stipulated in Clause 2 Article 3 of the Decree No. 181/2013/NĐ-CP and the following information: - When advertising pharmaceutical products on books, newspapers, magazines and flyers, the information such as precautions, dosage and administration must be included; - As for advertising of pharmaceutical products on audio and video news,