Nội dung toàn văn Circular No. 09/2015/TT-BYT stipulating the approval for contents of advertisements for special products
THE MINISTRY OF HEALTH | THE SOCIALIST REPUBLIC OF VIETNAM |
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, the contents defined in Clause 3 Article 3 of the Decree No. 181/2013/NĐ-CP indications, contraindication or warnings to special users, must be clear in order for audiences to hear or read in a sufficient and explicit manner;
- Advertisements aired on online newspapers, electronic information pages and advertising screens:
+ Sound advertisement contents must include information pieces which are the same as advertisements aired on audio and video news;
+ Non-sound advertisement contents must include information pieces which are the same as advertisements aired on books, newspapers, magazines and flyers;
If there are many advertising pages/shots, these pages/shot should be in steady motion, or paused deliberately in order for viewers to read all information conveyed on that page; pages or shots displaying product information should be unanimated without any movement in order for viewers to carefully read such information.
c) Pharmaceutical advertisement contents by means of outdoor means must include all necessary information stipulated in Clause 4 Article 3 of the Decree No. 181/2013/NĐ-CP.
d) Indications prevented from being included in a pharmaceutical advertisement content shall comprise:
- Indications stipulated in Clause 5 Article 3 of the Decree No. 181/2013/NĐ-CP;
- Indications of curing viral hepatitis and strange diseases currently emerging.
dd) Information or images banned for use in the pharmaceutical advertising shall include:
- Information or images stipulated in Clause 6 Article 3 of the Decree No. 181/2013/NĐ-CP;
- Overstatement of pathological conditions or effects of a pharmaceutical product;
- Images of animals or plants defined in the list of protected animals or plants;
- Information, images likely to make consumers believe that consultation with doctors before using the pharmaceutical product is not important; the pharmaceutical product is absolutely harmless to consumers; there is none of side effects or contraindications; and the pharmaceutical product is 100% effective .
Article 6. Requirements for grant of approval for a cosmetic advertisement content
1. Cosmetic products must conform to advertisement requirements stipulated in Point b Clause 4 Article 20 of the Law on Advertising.
2. Cosmetic advertisement contents must conform to regulations laid down in Article 4 of the Decree No. 181/2013/NĐ-CP and the followings:
a) Do not use images, costumes, names, mails and articles of other organizations, healthcare establishments, doctors, pharmacists or medical staff;
b) Features and effects of a cosmetic product must accord with its nature, classification as well as those that have been already made known to the public in accordance with legal regulations.
3. All necessary documents must be submitted as stipulated in Article 15 hereof.
4. The applicant for approval for advertisement contents is the organization that signs its name on the product notification, or the representative office of that organization, or the organization with its legal standing authorized in writing by that organization.
Article 7. Requirements for grant of approval for a food, food additive advertisement content
1. Food or food additive products endorsed by the certificate of declaration of conformity to food safety regulations (applicable to products that have not been governed by National technical regulations) or certificate of declaration of conformity issued by the competent regulatory authorities.
2. Advertisement contents must conform to regulations laid down in Article 5 of the Decree No. 181/2013/NĐ-CP and the followings:
a) As for advertisement contents other than those that have been already announced, legal documents, scientific studies that support these contents must be submitted while reference sources must be specified in the mockup or script of an advertisement; as for products with special use and storage, these must be presented in an advertisement;
b) An advertisement displayed on signboards, signs, banners, racks, shelves, or in the form of texts running at the bottom of the screen in a television program, imprinted on other items, or objects in the air, under the water, or movable objects, shall not be required to contain all information about how to use the product, effects, storage but shall be required to be consistent with the contents regulated by declaration of conformity or declaration of compliance with food safety regulations;
c) Do not advertise food products in the form of an article composed by a doctor, pharmacist, medical staff, and mention the content which may describe the effect of such products on disease treatment;
d) Prohibit using images, costumes, names or mails of organizations, healthcare establishments, doctors, pharmacists, medical staff and testimonials of patients to serve the purpose of advertising food products.
3. All necessary documents must be submitted as stipulated in Article 16 hereof.
4. Applicants for approval for advertisement contents are those who sign their names on the Certificate of Declaration of conformity or Certificate of Declaration of conformity with the food safety regulations (applicable to products on which the National technical regulations has not been set yet), or have their legal standing to be authorized in writing by the legal holder of Certificate of Declaration of conformity and Certificate of Declaration of conformity with the food safety regulations.
Article 8. Requirements for approval for contents of advertisements for chemicals, insecticides, disinfectants or sanitizers used in household appliance and health care industry.
1. All advertisement requirements stipulated in Point c Clause 4 Article 20 of the Law on Advertising must be met.
2. Advertisement contents must conform to regulations laid down in Article 6 of the Decree No. 181/2013/NĐ-CP.
3. All necessary documents must be submitted as stipulated in Article 17 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 organization that has its legal standing to be authorized in writing by the legal holder of the registration certificate of free circulation for products.
Article 9. Requirements for grant of approval for contents of advertisements for medical equipment
1. All advertisement requirements stipulated in Point g Clause 4 Article 20 of the Law on Advertising must be met.
2. Advertisement contents must conform to regulations laid down in Article 7 of the Decree No. 181/2013/NĐ-CP.
3. All necessary documents must be submitted as stipulated in Article 18 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 in respect of products manufactured in Vietnam or the import license in respect of imported products, or the Vietnam representative office of the organization that signs its name on the import license, or the organization with its legal standing authorized in writing by the organization that signs its name on the certificate of product circulation for products manufactured in Vietnam or the import license for imported products.
Article 10. Requirements for approval for contents of advertisements for baby milk and nutritional products
1. All advertisement requirements stipulated in Point d Clause 4 Article 20 of the Law on Advertising must be met, and these products must be endorsed by Certificate of Declaration of conformity or Certificate of Declaration of conformity with the food safety regulations (applicable to products on which the technical regulations have not been set yet) issued by regulatory authorities.
2. Advertisement contents must conform to regulations laid down in Article 8 of the Government’s Decree 181/2013/NĐ-CP and Clause 2 Article 6 of 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.
3. All necessary documents must be submitted as stipulated in Article 16 hereof.
4. Applicants for approval for advertisement contents are those who sign their names on the Certificate of Declaration of conformity or Certificate of Declaration of conformity with the food safety regulations (applicable to products on which the National technical regulations has not been set yet), or those who have their legal standing to be authorized in writing by the legal holder of Certificate of Declaration of conformity and Certificate of Declaration of conformity with the food safety regulations.
Article 11. Requirements for approval for contents of advertisements for health care services
1. All advertisement requirements stipulated in Point e Clause 4 Article 20 of the Law on Advertising must be met as follows:
a) The license for medical operations, applicable to healthcare establishments;
b) The certificate of medical practice, applicable to those required to achieve the practicing certificate by laws before being allowed to practise medical services.
2. Advertisement contents must conform to regulations laid down in Article 9 of the Decree No. 181/2013/NĐ-CP.
3. All necessary documents must be submitted as stipulated in Article 19 hereof.
4. Applicants for approval for advertisement contents are those who sign their names on the licence for medical operations, or those who have the legal standing to be authorized in writing by the legal holder of the license for medical operations.
Article 12. Authority to issue the certificate of approval for advertisement contents that fall within the remit of the Ministry of Health
1. Organizations affiliated to the Ministry of Health shall have authority to issue the Certificate of approval for advertisement contents:
a) Drug administration of Vietnam shall issue the certificate of approval for advertisement contents for pharmaceutical products as stipulated in Clause 1 Article 1 hereof;
b) Vietnam Food Administration shall issue the Certificate of approval for advertisement contents for functional food; micronutrient-fortified food; baby milk and nutritional products as stipulated in Clause 6 Article 1 hereof;
c) Medical Examination and Treatment Administration shall issue the Certificate of approval for advertisement contents for medical examination and treatment by employing modern medicinal practices released by healthcare establishments of which operations are licensed, and the list of professional practices is approved by the Minister of Health;
d) Traditional Medicine Administration of Vietnam shall issue the Certificate of approval for advertisement contents for medical examination and treatment by employing traditional medicinal practices released by healthcare establishments of which operations are licensed, and the list of professional practices is approved by the Minister of Health;
dd) Health Environment Management Agency shall issue the Certificate of approval for contents of advertisements for chemicals, insecticides, disinfectants or sanitizers used in household appliance and health care industry;
e) Medical Equipment and Facilities Administration shall issue the Certificate of approval for advertisement contents for medical equipment and facilities (acting on behalf of the Minister of Health to sign).
2. The Department of Health in a centrally-affiliated city or province shall issue the Certificate of approval for advertisement contents for:
a) Cosmetic products of the organization that signs their name on the notification of cosmetic products with their head office located within the remit of the Department of Health; If cosmetic products are advertised through conferences, seminars or events, the Department of Health in a centrally-affiliated city or province which is the proposed venue for these activities shall issue the Certificate of approval for advertisement contents;
b) Medical examination or treatment services provided by healthcare establishments of which operations are licensed and the list of professional practices are approved by the Director of the Department of Health.
3. The Food Safety and Hygiene Subdepartment affiliated to the Department of Health in a centrally-affiliated city or province shall have authority to:
a) Issue the Certificate of approval for advertisement contents for mineral water, bottled water, food additives, food processing aids;
b) Issue the Certificate of approval for advertisement contents for forms of advertising through conferences, seminars and events for promotion of food and food additive products as stipulated in Clause 3 Article 1 hereof which are organized in the areas that fall within their remit;
c) Give their opinions on advertisement contents for food products with the announcement of health effects when regulatory authorities assigned to issue the certificate or verify advertisement contents for food products under the authority of The Ministry of Industry and Trade and the Ministry of Agriculture and Rural Development carry out opinion polls.
Article 13. General requirements for application for approval for contents of advertisements for products, commodities or services under the authority of the Ministry of Health
1. The application shall include 01 set of documents.
2. Each application shall include the following documents:
a) Application form for approval for advertisement contents in accordance with regulations laid down in the Appendix 01 enclosed herewith;
b) The Certificate of Business Registration of an enterprise or the license for representative office establishment of a foreign dealer;
c) Contents of applications for approval for advertisements:
- If these are advertised on audio and video news, the applicant is required to prepare 01 recording of proposed advertisement content written in VCDs, CDs or in the form of soft copies together with 03 copies of proposed advertising scripts in which contents, proposed advertisement instruments, pictorial (applicable to video news), oral and music contents, must be clearly described;
- If these are advertised on the advertising means distinct from audio and video news, the applicant is obliged to prepare 03 copies of mockups of proposed advertisement contents printed in color in combination with soft copies recording the proposed advertisement contents;
- If these are advertised through conferences, seminars or events: In addition to materials stipulated in this point, the applicant is required to submit the followings: the valid sample of advertisement contents used in the program approved by competent authorities (applicable to advertisements of which contents have been approved), agenda in which the presentation title and time (dd/mm/yy), venue (specific address); presentation contents, materials and handouts; name tags including academic ranks and professional qualifications of presenters (presenters must hold qualifications or degrees appropriate to products, commodities and services to be advertised. Advertising of pharmaceutical products: Presenters must hold professional qualifications in pharmacy. Advertising of healthcare services: Presenters must hold professional qualifications in medicine. Advertising of foods, food additives and food processing aids: Presenters must hold professional qualifications in medicine and pharmacy or other university degree or higher degree in relevant disciplines.
d) Sample labels of these products or those approved by competent healthcare authorities, applicable to the case in which the law stipulates that product labels must be approved by competent healthcare authorities.
3. Other requirements imposed on applications:
a) If the authorized applicant is filing the application for approval for advertisement contents, the following documents must be shown:
- Legal authorization letter;
- The Certificate of business registration or the license for representative office establishment of a foreign dealer held by the authorized applicant.
b) Materials used for reference, demonstration and verification of information provided in the advertisement content:
- English materials must be translated into Vietnamese, enclosing the original English ones. Translated materials in Vietnamese must be sealed by the applicant for approval for advertisement contents;
- Materials in foreign languages other than English must be translated into Vietnamese, enclosing the original copies of these materials. Materials translated into Vietnamese must be notarized in accordance with legal regulations.
c) Materials included in the application must be high-quality printouts which are arranged to follow procedures stipulated in articles hereof. Colorful pages are placed in between to separate different parts, and the cover page and list of materials are required as well;
d) Documents included in the application for approval for advertisement contents must remain valid, or must be the authenticated duplicate or sealed duplicate of the applicant for approval for advertisement contents. All materials attached must be validated by stamp or edge stamp of the applicant for approval for advertisement contents;
dd) Sample advertisements should be displayed on the A4-size paper. Sample large-size outdoor advertisement should be displayed on the A3-size paper or the paper in other size, and the ratio of the sample advertisement to the real one must be specified.
4. Requirements imposed on applications submitted to the provider of level-4 online public services:
Applications shall be converted into soft files (01 copy) and governed under the direction of the provider of level-4 online public services
Article 14. Application for approval for a pharmaceutical advertisement content
1. Documents stipulated in Article 13 hereof.
2. User’s instruction leaflets approved by the Drug Administration of Vietnam – the Ministry of Health.
3. Permit for product free circulation issued by the Drug administration of Vietnam or the decision on issuance of pharmaceutical registration numbers at the Drug Administration of Vietnam.
Article 15. Application for approval for a cosmetic advertisement content
1. Documents stipulated in Article 13 hereof.
2. Notification of cosmetic products issued by competent authorities.
3. Valid and authoritative materials that demonstrate features and useful effects of these cosmetic products. This will happen if the advertisement content provides information about features or useful effects of these products but such information are not included in the notification of cosmetic products of which the receiving numbers have been issued by competent authorities.
Article 16. Application for approval for advertisement contents for foods, food additives, baby milk and nutritional products
1. Documents stipulated in Article 13 hereof.
2. The Certificate of Declaration of conformity or Certificate of Declaration of conformity with the food safety regulations (applicable to products on which the technical regulations have not been set yet) issued by regulatory authorities.
3. Description of details about products which have been verified by competent authorities.
4. Valid and authoritative materials that demonstrate features, useful effects and particulars of these products. This will apply if the advertisement content provides information about features, useful effects and particulars of these products but such information are not included in the description of details about products verified by competent authorities.
Article 17. Requirements for approval for contents of advertisements for chemicals, insecticides, disinfectants or sanitizers used in household appliance and health care industry.
1. Documents stipulated in Article 13 hereof.
2. The registration Certificate of free circulation for chemicals, insecticides, disinfectants or sanitizers.
Article 18. Application for approval for contents of advertisements for medical equipment
1. Documents stipulated in Article 13 hereof.
2. The permit for import of medical equipment or the registration certificate of free circulation for medical equipment.
Article 19. Application for approval for contents of advertisements for health care services
1. Documents stipulated in Article 13 hereof.
2. The permit for advertising of healthcare services granted by the Minister of Health or the Director of the Department of Health to healthcare establishments, and the professional practices approved by the Minister of Health or the Director of the Department of Health.
3. The Certificate of healthcare practicing held by the medical practitioner licensed to advertise their services. This will apply if the law stipulates that the practice certificate is compulsory.
Article 20. Procedure for grant of the certificate of approval for advertisement contents
1. The applicant for approval for advertisement contents shall submit the application to the competent authority as stipulated in Article 12 hereof (hereinafter referred to as the receiving authority).
2. If the application is not valid, within a permitted period of 05 working days from receipt of such application based on the date stamp affixed to incoming documents at the receiving authority, the receiving authority shall send a request to the applicant for correction or improvement of this application. The maximum period allowed for the applicant to correct or improve their application is 90 days from receipt of the written notification from the receiving authority. After this period, the application for approval for advertisement contents shall be annulled.
3. Within 10 working days from receipt of all necessary documents based on the date stamp affixed to incoming documents, the competent authority shall issue the Certificate of approval for advertisement content by completing the form recommended in the Appendix 03 enclosed herewith. In case of refusing to issue the Certificate of approval for advertisement contents, the competent authority shall respond to the applicant to clearly state the reasons for such refusal.
4. The receiving authority shall be responsible for posting the list of products, commodities and services within their jurisdiction for which the certificate of approval for advertisement contents have been issued, or the certificate of approval for advertisement contents ends its validity on their electronic information portal.
5. As for advertising in the form of seminars, conferences or events:
a) At least 02 working days prior to commencement of advertising activities, organizations or individuals that have products, commodities or services under the authority of the Ministry of Health and have obtained the Certificate of approval for advertisement contents from the regulatory agencies affiliated to the Ministry of Health in terms of advertising carried out in the form of seminars, conferences or events must send a written notification of the advertising form, time and location along with the duplicate of the certificate of approval for advertisement contents, sample advertisements or layouts approved by the Department of Health of the place where advertising activities take place in order for them to carry out their inspection and examination whenever necessary;
b) In case there is any change made to the location, time of seminars, conferences or events in comparison with the contents specified on the Certificate of approval for advertisement contents, these organizations or individuals must notify the Department of Health located at the area where these events are held at least 02 working days prior to commencement of advertising activities.
6. Procedures for applying for grant of approval for advertisement contents must be repeated from the first steps under the following circumstances:
a) The applicant for approval for advertisement contents that corrects or improves their application upon the written request for improvement or correction of this application sent by the receiving authority;
b) The applicant for approval for advertisement contents that fail to correct or improve their application by the deadline as stipulated in Clause 2 of this Article.
7. Any organization or individual committing violations against the law on advertising shall be subjected to the competent authority’s refusal to continue to receive their application for approval for advertisement contents until the decision on sanction against such violations has been granted and the violating organization or individual has managed to take action according to this decision.
Article 21. Reissuance of the certificate of approval for advertisement contents
1. The damaged or lost certificate of approval for advertisement contents shall be reissued under the following circumstances:
a) The organization that signs their name on the Certificate of approval for advertisement contents, or the authorized organization in accordance with regulations, shall send the written request for this reissuance to the competent authority that issued the previous certificate according to the form recommended in the Appendix 04 enclosed herewith;
b) Within 05 working days from receipt of the written request based on the date stamp affixed to incoming documents at the receiving authority, the competent authority for approval for advertisement contents shall consider reissuing the certificate of approval for advertisement contents to the applicant. In case of refusing to reissue the Certificate of approval for advertisement contents, the competent authority shall respond to the applicant to clearly state the reasons for such refusal.
2. Reissuance of the certificate of approval for advertisement contents shall be permitted if the validity period of that certificate ends as stipulated in Point a Clause 1, Point a Clause 2, Point a Clause 3, Point a Clause 4 and Point a Clause 5 of Article 23 hereof and the advertisement contents shall remain unchanged as follows:
a) The organization that signs their name on the Certificate of approval for advertisement contents, or the authorized organization in accordance with regulations, shall send their application for this reissuance to the competent authority that issued the previous certificate, including the following documents:
- Application form for reissuance of the certificate of approval for advertisement contents by completing the form recommended in the Appendix 04 enclosed herewith;
- One of the valid documents relevant to products, commodities or services for which advertisement contents are requested to be approved as follows:
+ As for pharmaceutical advertisement: The certificate of free circulation for products issued by the Drug Administration of Vietnam and the decision on issuance of the pharmaceutical registration numbers granted by this Administration;
+ As for cosmetic advertisement: the notification of cosmetic products issued by competent authorities;
+ As for advertising of food or food additive products: the Certificate of Declaration of conformity or Certificate of Declaration of conformity with the food safety regulations (applicable to products on which the technical regulations have not been set yet) issued by regulatory authorities; the description of details about products; samples of main labels approved by competent authorities;
+ As for advertising of chemicals, insecticides, disinfectants or sanitizers used in household appliance and healthcare industry: the certificate of free circulation for chemicals, insecticides and fertilizers;
+ As for advertising of medical equipment: the permit for import of medical equipment or the registration certificate of free circulation for medical equipment.
- The expired certificate of approval for advertisement contents along with the approved advertisement sample or layout.
b) Within 05 working days from receipt of the written request based on the date stamp affixed to incoming documents at the receiving authority, the competent authority for approval for advertisement contents shall consider reissuing the certificate of approval for advertisement contents to the applicant. In case of refusing to reissue the Certificate of approval for advertisement contents, the competent authority should send a written notification in which the reasons for such refusal must be clearly stated.
3. Reissuance of the certificate of approval for advertisement contents shall be permitted if the validity period of that certificate still remains but there is a change made to the name, address of the organization or individual that takes responsibility to launch their products, commodities or services to the market, and the advertisement contents remain unchanged as follows:
a) The organization that signs their name on the Certificate of approval for advertisement contents, or the authorized organization in accordance with regulations, shall send their application for this reissuance to the competent authority that issued the previous certificate, including the following documents:
- Application form for reissuance of the certificate of approval for advertisement contents by completing the form recommended in the Appendix 04 enclosed herewith;
- The preexisting certificate of approval for advertisement contents along with the approved advertisement sample or layout;
- The document of the competent authority stating the change made to the name, address of the organization or individual that takes responsibility to launch their products, commodities or services to the market.
b) Procedure for reissuance of the certificate of approval for advertisement contents shall be governed under the provisions of Clause 2, 3, 4, 5 Article 20 hereof.
4. Reissuance of the certificate of approval for advertisement contents shall be permitted if the validity period of that certificate ends as stipulated in Article 23 hereof but it does not fall into the case stipulated in Clause 2 of this Article and the case in which the advertisement contents are changed or amended but it does not fall into the case stipulated in Clause 3 of this Article as well:
The enterprise must go through procedures for application for approval for advertisement contents which are the same as the initial application.
5. Application for reissuance of the certificate of approval for advertisement contents must conform to requirements stipulated in Clause 3 Article 13 hereof.
Article 22. Method of numbering the certificate of approval for advertisement contents
1. As for advertisement contents subject to the certificate of approval for advertisement contents issued by competent agencies affiliated to the Ministry of Health, the numbering shall adhere to the principle as follows: the ordinal numbers/issuance year/XNQC- the shortened name of the issuer. Example: 123/2015/XNQC-ATTP
2. As for the certificate of approval for advertisement contents issued by the Department of Health, and Food Safety and Hygiene Subdepartment, the numbering shall adhere to the principle as follows: the ordinal numbers/issuance year/XNQC- the shortened name of the issuer and the shortened name of a centrally-affiliated city and province. Example: 123/2015/XNQC-YTHN or 123/2015/XNQC-ATTPHN
Article 23. Circumstances under which the validity of the certificate of approval for advertisement contents is terminated
1. Circumstances under which the validity of the certificate of approval for advertisement contents is terminated
a) Pharmaceutical products have the expired registration numbers;
b) Pharmaceutical products have suspended registration numbers, or pharmaceutical products are subject to the warning of restricted use given by regulatory authorities;
c) Change has been made to information about indications, contraindications or administration dosage.
2. Circumstances under which the validity of the certificate of approval for advertisement contents for cosmetic products is terminated:
a) The receiving numbers of the notification of cosmetic products has expired;
b) Cosmetic products subject to suspension of free circulation or revocation or recall of the receiving numbers of the notification of products;
c) There is any change made to information affecting the safety and quality of cosmetic products.
3. Circumstances under which the validity of the certificate of approval for advertisement contents for foods, food additives, baby milk and nutritional products:
a) The Certificate of Declaration of Conformity or Certificate of Declaration of conformity with the food safety regulations has been expired;
b) The enterprise is subject to revocation of the certificate of conformity with food safety and hygiene requirements;
c) Products or commodities are subject to change to ingredients or useful effects;
d) Products or commodities are subject to suspension of free circulation, or are recalled.
4. Circumstances under which the Certificate of approval for contents of advertisements for chemicals, insecticides, disinfectants or sanitizers used in household appliance and health care industry is expired:
a) The registration Certificate of free circulation for chemicals, insecticides and fertilizers used in household appliance and healthcare industry has expired;
b) Products or commodities are subject to suspension of free circulation, or are recalled;
c) Products or commodities have been changed or amended in terms of their ingredients, useful effects or other information causing impacts on the product safety in comparison with information about products or commodities specified in the valid registration certificate of free circulation issued by the Ministry of Health.
5. Circumstances under which the validity of the certificate of approval for medical equipment is terminated:
a) The import permit or the registration certificate of free circulation for products or commodities has expired;
b) Products or commodities are subject to suspension of free circulation, or are recalled.
6. Circumstances under which the validity of the certificate of approval for advertisement contents for healthcare services is terminated:
a) Healthcare establishments are subject to revocation of the permit for operations, their operations are suspended;
b) Healthcare establishments have been deprived of the ownership of the permit for operations in accordance with legal regulations on penalties for administrative violations;
c) Healthcare establishments have been reissued the permit for operations due to change to their scope of professional operations in relation to healthcare services allowed to be advertised.
7. Other circumstances in accordance with legal regulations.
Chapter III
IMPLEMENTARY PROVISIONS
Article 24. Effect
1. This Circular shall come into force from July 16, 2015.
2. From the effective date of this Circular, the following documents or regulations shall be abolished:
a) Regulations on advertising of pharmaceutical products enshrined in the Circular No. 13/2009/TT-BYT of the Minister of Health dated September 1, 2009 on providing guidance on pharmaceutical product communication and advertising operations;
b) Regulations on pharmaceutical advertising enshrined in the Circular No. 45/2011/TT-BYT of the Minister of Health dated December 21, 2011 on amendments to several articles of the Decision No. 1570/2000/QĐ-BYT of the Minister of Health dated May 22, 2000 on application of the good laboratory practices; the Decision No. 2701/2001/QĐ-BYT of the Minister of Health dated June 29, 2001 on application of the good storage practices; the Circular No. 06/2004/TT-BYT of the Ministry of Health dated May 28, 2004 on providing guidance on pharmaceutical contract manufacturing; the Decision No. 3886/2004/QĐ-BYT of the Ministry of Health dated November 13, 2004 on application of the good manufacturing practices in conformity with the warning issued by the World Health Organization; the Circular No. 13/2009/TT-BYT of the Ministry of Health dated September 1, 2009 on providing guidance on pharmaceutical communication and advertising operations; the Circular No. 22/2009/TT-BYT of the Ministry of Health dated November 24, 2009 on stipulating the pharmaceutical registration; the Circular No. 47/2010/TT-BYT dated December 29, 2010 on providing guidance on export or import of pharmaceutical products and packages in physical contact with pharmaceutical products;
c) The Circular No. 42/2010/TT-BYT of the Ministry of Health dated December 15, 2010 on promulgating the List of medicinal active ingredients and herbal ingredients permitted to be advertised through radio or television programs;
d) Regulations on advertising of cosmetic products enshrined in the Circular No. 06/2011/TT-BYT of the Minister of Health dated January 25, 2011 on providing regulations on cosmetic product administration;
dd) The Circular No. 08/2013/TT-BYT of the Minister of Health dated March 13, 2013 on providing guidance on advertising of food products under the authority of the Ministry of Health;
Article 25. Terms of reference
1. Where documents used as references in this Circular have been amended, replaced or abolished, newly-adopted documents shall be applied.
2. Where documents such as certificates, licenses, notifications and decisions on issuance of the pharmaceutical registration number stipulated in this Circular are subject to amendment or replacement or change of document title stipulated in the competent authority’s legal documents, newly-adopted documents shall be applied.
Article 26. Transition provisions
1. Organizations or individuals that have filed their applications for permission for advertising of special products, commodities or services under the authority of the Ministry of Health shall obtain the notice of receipt of applications for permission for advertising from regulatory authorities before the effective date of this Circular shall be allowed to continue their advertising activities until the validity of notice of receipt ends.
2. As for products, commodities or services that meet requirement for issuance of the certificate of approval for Internet-based advertisement contents in the form of online public services, competent authorities shall issue that certificate on the basis of regulations laid down in this Circular and other relevant laws.
Article 27. Responsibility for implementation
1. The Heads of competent authorities for issuance of the certificate of approval for advertisement contents as prescribed in Article 12 hereof shall be responsible for performing their assigned tasks according to this Circular, and carrying out examination and supervision of advertising activities after issuance of that certificate is completed.
2. The applicants for approval for advertisement contents shall assume responsibility for legitimacy and accuracy of information and materials provided in their applications and advertisement contents.
3. The Director of the Department of Legal Affairs, the Chief of the Ministry Office, the Chief Inspector of the Ministry, the Department’s Director, the Administration’s Director, the General Director of Departments, Administrations or General Departments affiliated to the Ministry of Health, the Director of the Department of Health, the Director of the Food Safety Subdepartment in a centrally-affiliated city or province as well as other relevant organization or individual, shall take responsibility to implement this Circular.
In the course of implementation, if there is any difficulty that may arise, agencies, organizations or individuals concerned should report to the Ministry of Health for to conduct further study and recommend possible solutions./.
| PP. THE MINISTER |
APPENDIX 01
APPLICATION FORM FOR APPROVAL FOR ADVERTISEMENT CONTENTS
(Issued together with the Circular No /2015/TT-BYT of the Minister of Health dated ……….., 2015 on the approval for contents of advertisements for special products, commodities and services under the authority of the Ministry of Health)
NAME OF THE APPLICANT | THE SOCIALIST REPUBLIC OF VIETNAM |
No.: /Abbreviated name of the applicant | ……(1)……, ………. 20…. |
APPLICATION
Approval for advertisement contents
Dear (2)……………………………,
1. Contact information about the applicant: ..................................................................................................................
1.1. The applicant's name: ...............................................................................................
1.2. Address: (3).............................................................................................................
............................................................................................................................................
Telephone number: .........................................................Fax: .........................................
Applies for issuance of approval for advertisement contents for………………………….:
No. | Description of product, commodity or service (specifying type, ....(if any)) | Numerical code of the Certificate of free circulation for product, or the Decision on issuance of the registration number of pharmaceutical product/ Notification of cosmetic product/ Certificate of Declaration of conformity with the food safety regulations or Certificate of Declaration of Conformity/ Certificate of free circulation for chemicals, insecticides, fertilizers used in household appliance and healthcare industry/ Permit for import of medical equipment or Certificate of free circulation for medical equipment/ Permit for healthcare service operations and the Decision on approval for the list of professional practices |
|
|
|
|
|
|
Means of advertising:
(If verbal, pictorial or printing press are used for advertising, please specify the specific title of such press; If seminars, conferences or events are used for advertising, please specify proposed schedule and venue)
……………………………………………………………………………………………
……………………………………………………………………………………………
Application including the following documents or materials:
……………………………………………………………………………………………
……………………………………………………………………………………………
I herein undertake all information and documentation mentioned above are genuine and I am committed to advertising product, commodity or service under the authority of the Ministry of Health in accordance with the approved contents.
I am looking forward to your consideration and issuance of approval for the advertisement content./.
| The Director or Legal representative |
APPENDIX 02
LIST OF PHARMACEUTICAL ACTIVE INGREDIENTS AND HERBAL MATERIALS REGISTERED FOR PERMISSION TO BE ADVERTISED ON VERBAL OR PICTORIAL PRESS
(Issued together with the Circular No /2015/TT-BYT of the Minister of Health dated ……….., 2015 on the approval for contents of advertisements for special products, commodities and services under the authority of the Ministry of Health)
1. CHEMICALLY SYNTHESIZED PHARMACEUTICALS
No. | Active ingredients | Administration, dosage form, limited content or concentration | Other specific provisions |
1 | Acetylcysteine | Oral administration: all forms |
|
2 | Acetylleucine | Oral administration: all forms |
|
3 | Single acetylsalicylic acid (Aspirin) used singly or in combination with Vitamin C and/or Citric Acid and/or Sodium bicarbonate and/or Sodium Salicylate | Oral administration: all forms | Medication for pain or fever relief, anti-inflammation |
4 | Alginic acid (Sodium alginate) used singly or in combination with aluminum or magnesium compounds | Oral administration: all forms |
|
5 | Single or compound amino acid (including amino acid combined with Vitamins) | Oral administration: all forms | Medication for amino acid supplement to human body |
6 | Aminobenzoic acid (para-aminobenzoic acid) | Oral administration: all forms |
|
7 | Pure or compound Benzoic acid | Topical administration Oral administration: lozenge |
|
8 | Single or compound Boric acid | Topical administration Eye drop |
|
9 | Citric acid combined with sodium or potassium | Oral administration: all forms |
|
10 | Cromoglicic acid and cromoglicat of all types | Eye, nasal drop with limited concentration calculated by Cromoglicic acid ≤ 2% |
|
11 | Dimecrotic acid | Oral administration: all forms |
|
12 | Folic acid used singly or in combination with iron and/or B-group Vitamins, minerals or Sorbitol | Oral administration: all forms | Medication for anti-anaemia, nutritional supplement |
13 | Glycyrrhizic acid (Glycyrrhizinat) combined with other active ingredients such as Chlorpheniramine Maleate, Dl-methylephedrine and caffeine, etc. | Oral administration: all forms, including lozenge Topical administration |
|
14 | Single or compound Lactic acid | Topical administration |
|
15 | Mefenamic acid | Oral administration: all forms |
|
16 | Salicylic acid used singly or in combination with topical pharmaceutical products (in combination with lactic acid; precipitate phosphorus, etc.) | Topical administration |
|
17 | Albendazol | Oral administration: all forms | Anti-worm medication |
18 | Dichlorobenzyl alcohol used in combination and contained in lozenges | Oral administration: lozenges |
|
19 | Polyvinyl alcohol | Topical administration |
|
20 | Alimemazin tartrat (Trimeprazin tartrat) | Oral administration: all forms |
|
21 | Allantoin used in combination and contained in topical or rectal suppository pharmaceuticals (cepae fluid extracts, etc.) | Topical administration Suppositories |
|
22 | Allantoin used in combination with Vitamins and/or Chondroitin | Eye drop |
|
23 | Almagate | Oral administration: all forms |
|
24 | Ambroxol used singly or in combination with cough suppressants, fever or pain relief medicines | Oral administration: all forms with limited active ingredients as follows: - Ambroxol clorhydrate with dose unit measurement ≤ 30mg/unit - Ambroxol clorhydrate without dose unit measurement ≤ 0.8% |
|
25 | Amylase used singly or in combination with protease and/or lipase and/or cellulase | Oral administration: all forms |
|
26 | Amylmetacresol used in combination and contained in lozenges (like essential oil or Bacitracin, etc.) | Oral administration: lozenges |
|
27 | Argyron | Eye drop Topical administration |
|
28 | Aspartame | Oral administration: all forms |
|
29 | Single or compound Aspartat | Oral administration: all forms |
|
30 | Attapulgite | Oral administration: all forms |
|
31 | Azelastin | Eye, nasal drop |
|
32 | Silver sulfadiazine | Topical administration |
|
33 | Bacitracin combined with several other active ingredients in lozenges (combined with Neomycin Sulfate, Amylocaine, Tixocortol, etc.) | Oral administration: lozenges |
|
34 | Benzalkonium used in combination in topical medicines (with choline, salicylic acid, Nystatin and Diiodohydroxyquin, etc.), or in lozenges (with Tyrothricin, Bacitracin and essential oil, etc.) | Topical administration Lozenges |
|
35 | Compound benzocaine | Topical administration all forms with limited benzocaine ≤ 10%; Rectal suppositories Oral administration: lozenges |
|
36 | Benzoyl peroxide used singly or combined with Iodine and/or phosphorus | Topical administration all forms with limited concentration ≤ 10% |
|
37 | Benzydamine hydrochloride used singly or in combination | Topical administration: oral mucosal gel, mouth rinse, oromuscosal spray Oral administration: lozenges |
|
38 | Benzydamine salicylate used singly or in combination | Topical administration |
|
39 | Compound benzyl benzoate contained in topical ingredients (combined with essential oil, isopropyl alcohol, etc.) | Topical administration; all forms Patches |
|
40 | Berberine | Oral administration: all forms |
|
41 | Biclotymol used singly or in combination with Enoxolone and/or Phenylephrine HCl and/or Clorpheniramin maleat and/or essential oil | Topical administration Nasal drop Oral administration: lozenges |
|
42 | Bifonazole used singly or combined with Urea | Topical administration |
|
43 | Bisacodyl | Oral administration: measured unit dose with content ≤ 10mg/unit |
|
44 | Bismuth salts | Oral administration: all forms |
|
45 | Boldin | Oral administration: all forms |
|
46 | Bromelain used singly or combined with trysin | Oral administration: all forms |
|
47 | Bromhexin HCl used singly or in combination in expectorants, fever or pain relief medicines | Oral administration: all forms with a restricted amount of Bromhexin HCl as follows: - With measured dosage ≤ 8mg/unit - Without measured dosage ≤ 0.8% Rectal suppository |
|
48 | Brompheniramine maleates used singly or in combination in expectorants, fever or pain relief medicines | Oral administration: all forms |
|
49 | Bufexamac used singly or in combination in topical, rectal suppository medicines (with Titanium dioxide, Bismuth, Subgallate, Lidocaine, etc.) | Topical administration Rectal suppositories |
|
50 | Butoconazol | Topical administration |
|
51 | Caffeine (combined with paracetamol) | Oral administration: all forms |
|
52 | Calamine used singly or in combination in topical medicines | Topical administration |
|
53 | Calcium (including compound forms) used singly or in combination with Vitamin D (Calcitriol) and/or Vitamins and/or Ipriflavone | Oral administration: all forms | Medication for calcium supplement to human body |
54 | Carbinoxamine used singly or in combination in expectorants, fever or pain relief medicines (with Bromhexine and/or Paracetamol) | Oral administration |
|
55 | Carbocysteine | Oral administration: all forms |
|
56 | Carbomer | Topical administration Eye drop |
|
57 | Catalase used singly or in combination in topical medicines (with Neomycin) | Topical administration |
|
58 | Cetirizine dihydrocloride | Oral administration: all forms |
|
59 | Cetrimide used in combination in topical medicines (Lidocaine, zinc, Calamine, Aminacrine, essential oil, etc.) | Topical administration |
|
60 | Cetrimonium compounds used in topical medicines, lozenges (combined with Lidocaine; Tyrothricin, essential oil, etc.) | Topical administration Oral administration: lozenges |
|
61 | Chitosan (Polyglusam) | Topical administration |
|
62 | Choline used singly or in combination with amino acids, Vitamins in medicines administered orally; in combination with salicylic acids, Benzalkonium, etc. in topical pharmaceuticals | Oral administration: all forms Topical administration |
|
63 | Chondroitin used singly or in combination with Glucosamine and/or fish oil and/or vitamins and/or amino acids | Oral administration: all forms |
|
64 | Chondroitin used singly or in combination with Borneol and/or Vitamins | Eye drop Topical administration |
|
65 | Ciclopirox olamine | Topical administration |
|
66 | Cinnarizine | Oral administration: all forms |
|
67 | Cinchocaine used singly or in combination in topical, rectal suppository medicines (with Hydrocortisone, Neomycin, Aesculin, etc.) | Topical administration Rectal suppositories |
|
68 | Citrulline | Oral administration: all forms |
|
69 | Chlorhexidine | Topical administration |
|
70 | Chlorophyll | Oral administration: all forms |
|
71 | Clorpheniramine maleate used singly or in combination in expectorants, fever or pain relief medicines | Oral administration: all forms Metered-dosage single form: Clorpheniramine maleate ≤ 4mg/unit. |
|
72 | Clorpheniramine maleate combined with Chondroitin and/or Vitamins | Eye drop |
|
73 | Clotrimazol | Oral administration: all forms with limited concentration ≤ 3% Vaginal suppositories |
|
74 | Coenzyme Q10 used singly or combined with Vitamins | Oral administration: all forms |
|
75 | Crotamiton | Topical administration |
|
76 | Dequalinium used singly or compounds contained in topical medicines or lozenges (Tyrothricin; Hydrocortisone; glycyrrhetinic acid; Lidocaine, etc.) | Topical administration Vaginal suppositories Oral administration: lozenges |
|
77 | Desloratadine | Oral administration: all forms with limited content ≤ 5mg/metered-dosage unit |
|
78 | Dexbrompheniramine maleate used singly or compounds contained in expectorants, fever or pain relief medicines | Oral administration: all forms |
|
79 | Dexclorpheniramine maleate used singly or in combination in expectorants, fever or pain relief medicines | Oral administration: all forms |
|
80 | Dexibuprofen | Oral administration: all forms with limited content ≤ 400mg/metered-dosage unit. |
|
81 | Dexpanthenol | Eye drop Topical administration |
|
82 | Diclofenac used singly or combined with Methyl salicylate; essential oil-based ingredients, etc. | Topical administration Eye drop (single) |
|
83 | Dicyclomine | Oral administration: all forms |
|
84 | Diethylphtalate (DEP) | Topical administration |
|
85 | Dimenhydrinate | Oral administration: all forms |
|
86 | Dimethicone (Dimethylpolysiloxane) used singly or combined with Guaiazulene | Oral administration: all forms |
|
87 | Dimethicone compound contained in topical medicines (with zinc, calamine, cetrimide, etc.) | Topical administration |
|
88 | Dimethindene | Oral administration: all forms Topical administration |
|
89 | Disodium inosine monophosphate | Eye drop |
|
90 | Diosmectite (Dioctahedral smectite) | Oral administration: all forms |
|
91 | Diosmin combined with Hesperidin and/or flavonoid-contained herbal extracts | Oral administration: all forms |
|
92 | Diphenhydramine hydrochloride or monocitrate | Oral administration: all forms with limited content (calculated by the base form) as follows: - With measured dosage ≤ 50mg/unit - Without measured dosage ≤ 2.5% |
|
93 | Domperidone | Oral administration: all forms with a limited content as follows: - With measured dosage ≤ 10mg/unit - Without measured dosage ≤ 0.1% |
|
94 | Copper sulfate | Topical administration |
|
95 | Doxylamine compounds contained in expectorant, fever, pain relief medicines (with Paracetamol, other active ingredients specified in the list of non-prescription medicines | Oral administration: all forms |
|
96 | Econazole used singly or combined with Hydrocortisone | Oral administration, limited concentration of Hydrocortisone calculated in the base form ≤ 0.05% |
|
97 | Enoxolone used singly or in combination in topical medicines or lozenges | Topical administration: skin cream, oral mucosal cream, mouth rinse Oral administration: lozenges |
|
98 | Eprazinone | Oral administration: all forms |
|
99 | Esdepallethrin compounds contained in topical medicines (with Piperonyl, Spregal, essential oil, substances contained in essential oil) | Topical administration |
|
100 | Single or compound Ethanol | Topical administration (sterilization alcohol) Oral administration: compound form |
|
101 | Etofenamate | Topical administration |
|
102 | Fenticonazole | Topical administration |
|
103 | Fexofenadine | Oral administration: all forms |
|
104 | Flurbiprofen | Lozenges Topical administration Eye drop |
|
105 | Glucosamine used singly or in combination with Chondroitin and/or Vitamins | Oral administration: all forms |
|
106 | Glucose or Dextrose used singly or in combination with Sodium or Potassium | Oral administration: all forms | Medication for sugar or electrolyte supplement. |
107 | Glycerine used singly or in combination in topical medicines, eye drops (with Polysorbate 80) | Topical administration Eye drop |
|
108 | Glycerol combined with herbal extracts | Rectal suppositories |
|
109 | Guaiphenesin used singly or in combination with active ingredients specified in the list of over-the-counter medicines with useful effects of cough suppression, fever and pain relief. | Oral administration: all forms |
|
110 | Hexamidine used singly or combined with Cetrimide, Lidocaine, Clotrimazole and Catalase) | Topical administration |
|
111 | Hexetidine used singly or combined with Benzydamine, Cetylpyridinium, Choline Salicylate, Methyl salicylate, essential oil, etc.) | Topical administration: skin application cream, mouth rinse |
|
112 | Hydrocortisone used singly or combined with Miconazole, Econazole, Tioconazole, Neomycin) | Topical administration: all forms with Hydrocortisone concentration ≤ 0.5% |
|
113 | Hydrogen peroxide (hydrogen peroxide) used singly or combined with sodium lauryl sulfate and/or essential oil | Topical administration |
|
114 | Hydrotalcit | Oral administration: all forms |
|
115 | Hydroxypropyl Methylcellulose (HPMC) | Eye drop |
|
116 | Hyoscine (Scopolamine) butylbromid used singly or in combination with Meclizine hydrochloride | Oral administration: all forms, including chews. Limited content ≤ 20mg/ metered-dosage unit Patches |
|
117 | Hypromellose used singly or combined with Dextran 70 and/or Carbomer | Eye drop: all forms |
|
118 | Ibuprofen | Oral administration: all forms with limited content ≤ 400mg/metered-dosage unit. Topical administration |
|
119 | Ichthammol | Topical administration |
|
120 | Iodine combined with Potassium iodide and/or Benzoic Acid and/or Salicylic Acid | Topical administration: Concentration ≤ 5% |
|
121 | Isoconazol | Topical administration |
|
122 | Isopropyl Methylphenol | Topical administration |
|
123 | Zinc oxide, Zinc pyrithione, Zinc Gluconate, Zinc undecylenate used singly or in combination in topical medicines | Topical administration |
|
124 | Zinc sulfate | Topical administration Eye drop |
|
125 | Ketoconazole used in singly or combined with Zinc pyrithione and/or Hydrocortisone and/or Trolamine | Topical administration: all forms with Ketoconazole concentration ≤ 2% |
|
126 | Ketoprofen | Topical administration |
|
127 | Lactitol | Oral administration: all forms |
|
128 | Lactoserum atomisate | Topical administration |
|
129 | Lactulose | Oral administration: all forms |
|
130 | L-Carnitin used singly or combined with Vitamins | Oral administration: all forms |
|
131 | Levocetirizine | Oral administration: all forms |
|
132 | Single or compound Lidocaine | Topical administration |
|
133 | Lindan (Benhexachlor, 666, Gamma-BHC) used singly or combined with Lidocaine | Topical administration: Lindan concentration ≤ 1% |
|
134 | Loratadine used singly or in combination with Paracetamol | Oral administration: all forms with limited content (calculated by the base form) as follows: - With measured dosage: Loratadins ≤ 10mg/unit; - Without measured dosage: Loratadine ≤ 0.1% |
|
135 | Loxoprofen | Oral administration: all forms |
|
136 | Macrogol | Oral administration: all forms Rectal suppositories |
|
137 | Magaldrate used singly or combined with Aluminum, Magnesium, Alginic Acid compounds (or Alginate salts). | Oral administration: all forms |
|
138 | Magnesium, including its salts or compounds | Oral administration: all forms | Medication for magnesium supplement to human body, gastric acid neutralization or laxativity. |
139 | Mangiferin | Topical administration |
|
140 | Mebendazole | Oral administration: all forms with a limited content as follows: - With measured dosage ≤ 500mg/unit - Without measured dosage ≤ 2% |
|
141 | Fungi enzyme (cellulase fongique) | Oral administration: all forms |
|
142 | Digestive enzymes used singly or in combination, including vitamins | Oral administration: all forms |
|
143 | Menthol combined with others such as essential oil complex, Methyl Salycilate, etc. | Oral administration: all forms Topical administration: all forms |
|
144 | Mequinol | Topical administration |
|
145 | Mequitazine | Oral administration: all forms Topical administration |
|
146 | Mercurocrome (Antiseptic solution) | Topical administration: Package size ≤ 30ml |
|
147 | Methyl salicylate compounds contained in lozenges, topical medicines (combined with essential oil, etc.) | Topical administration Patches Lozenges |
|
148 | Metronidazole | Topical administration |
|
149 | Miconazole | Topical administration Vaginal cream ≤ 2% |
|
150 | Miconazole combined with Hydrocortisone | Topical administration Vaginal cream with Miconazole content ≤2%; Hydrocortisone content ≤0.05% |
|
151 | Minoxidil | Topical administration: all forms with content ≤ ≤5% |
|
152 | Mupirocin | Topical administration |
|
153 | Myrtol used singly or compound contained in lozenges | Oral administration: all forms Topical administration |
|
154 | Naproxen | Oral administration: all metered-dosage forms with limited content ≤ 275mg/unit |
|
155 | Single or compound Sodium benzoate | Oral administration: all forms |
|
156 | Single or compound Sodium bicarbonate | Oral administration: all forms |
|
157 | Single or compound Sodium carbonate | Oral administration: all forms |
|
158 | Sodium Carboxymethylcellulose (Na CMC) | Eye drop |
|
159 | Sodium chloride used singly or in combination with potassium citrate, sodium citrate, etc. | Oral administration: all forms Topical administration Eye or nasal drop with concentration 0.9% |
|
160 | Ducosate sodium | Oral administration: all forms |
|
161 | Sodium fluoride compound | Topical administration: teeth cleaning or mouth rinse |
|
162 | Sodium hyaluronate (Hyaluronic acid) | Topical administration |
|
163 | Sodium Monofluorophosphate | Topical administration, including oromucosal cleaning |
|
164 | Sodium Salicylate compound | Oral administration: compound form contained in lozenges Topical administration |
|
165 | Neomycin sulfate compound contained in lozenges (zinc; Bacitracin; Amylocaine, etc.), topical medicines | Oral administration: lozenges Topical administration |
|
166 | Dietary elements: Chromium, copper, potassium, magnesium, zinc, etc. used singly or in combination, including those combined with vitamins | Oral administration: all forms | Medication for mineral supplement to human body |
167 | Aluminum, magnesium, calcium and aluminum compound, magnesium, calcium used singly or in combination | Oral administration: all forms | Medication for gastric acid neutralization, gastric ulcer or duodenum mobility. |
168 | Nomahydrated Natri Sulfid + Saccharomyces Cerevisiae | Oral administration: all forms Topical administration |
|
169 | Single or compound Nystatin | Topical administration |
|
170 | Omeprazole | Oral administration: metered-dosage forms with content ≤10mg/unit | Medication for gastro esophageal reflux disease. |
171 | Ossein hydroxy apatite | Oral administration: all forms |
|
172 | Oxeladin | Oral administration: all forms |
|
173 | Oxomemazine | Oral administration: all forms |
|
174 | Oxymetazoline | Nasal drop with concentration 0.5% |
|
175 | Pancreatin used singly or in combination with Simethicone and/or digestive enzymes and/or Group-B vitamins and/or Azintamide | Oral administration: all forms |
|
176 | Panthenol | Topical administration Eye drop |
|
177 | Single paracetamol | Oral administration: all forms Rectal suppository | Compound form stipulated in the List |
178 | Paracetamol combined with active ingredients specified in this List with useful effects of cough suppression, fever, pain relief and anti-inflammation | Oral administration: all forms |
|
179 | Pentoxyverin | Oral administration: all forms |
|
180 | Phenylephrine HCl | Eye or nasal drop with concentration ≤ 1% |
|
181 | Phenylephrine HCl used in combination in topical medicines (such as Petrolatum sperti yellow; Mineral oil light; Shark liver oil...) | Topical administration |
|
182 | Phenylephrine HCl used in combination in cough suppressant, fever and pain relief medicines | Oral administration: all forms Rectal suppository |
|
183 | Phospholipid | Oral administration: all forms |
|
184 | Picloxydine | Eye drop |
|
185 | Piroxicam | Topical administration: all forms with content ≤ 1% |
|
186 | Policresulen (Metacresolsulphonic acid-formaldehyd) | Topical administration Rectal suppository |
|
187 | Polyethylene glycol 400 used singly or in combination with Propylene glycol | Eye drop |
|
188 | Polysacharide | Oral administration: all forms |
|
189 | Polytar used singly or in combination in topical medicines (such as Zinc Pyrithione, etc.) | Topical administration |
|
190 | Povidone Iodine | Topical administration: all forms (including mouth rinse with concentration ≤ 1%). Eye drop |
|
191 | Promethazine HCl used singly or in combination in cough suppressant, fever, pain relief medicines (with Carbocystein; Paracetamol, etc.) | Oral administration: all forms with limited content, concentration of Promethazine (calculated by the base form) as follows: - With measured dosage ≤ 12.5mg/unit; - Without measured dosage ≤ 0.1% Topical administration: concentration ≤ 2% |
|
192 | Pyrantel | Oral administration: all forms | Medication for worm infection |
193 | Rutin used singly or in combination with Vitamin C and/or herbal extracts | Oral administration: all forms |
|
194 | Saccharomyces boulardii | Oral administration: all forms |
|
195 | Saccharomyces cerevisiae and Magnesium sulfate trihydrate | Oral administration: all forms |
|
196 | Compound iron in the single active ingredient form or iron combined with vitamin and mineral based medicines | Oral administration: all forms | Medication for iron supplement to human body |
197 | Organic selenium used in combination in Vitamin, mineral contained medicines | Oral administration: all forms with limited content as follows: - With measured dosage ≤ 50mcg/unit |
|
198 | Selenium sulfide | Topical administration |
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199 | Silymarin used singly or in combination with Vitamin C and/or herbal extracts. | Oral administration: all forms |
|
200 | Simethicone used singly or in combination with Pancreatin and/or Desoxycholic Acid and/or Group-B Vitamins and/or digestive enzymes | Oral administration: all forms |
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201 | Simethicone combined with aluminum compound, magnesium and/or Dicyclomine and/or activated carbon | Oral administration: all forms |
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202 | Single or compound Sorbitol | Oral administration: all forms |
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203 | Sterculia (gum sterculia) | Oral administration: all forms Rectal suppository |
|
204 | Sucralfate | Oral administration: all forms |
|
205 | Sulbutiamine | Oral administration: all forms |
|
206 | Sulfogaiacol used singly or in combination in fever, pain relief or cough depression medicines | Oral administration: all forms |
|
207 | Terbinafine | Topical administration: all forms with content ≤ 1% |
|
208 | Single terpin | Oral administration: all forms |
|
209 | Tetrahydrozoline | Nasal drop |
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210 | Activated carbon used singly or in combination with Simethicone | Oral administration: all forms |
|
211 | Essential oil (including Menthol, Pinen, Camphor, Cineol, Fenchone, Borneol, Anethol, Eucalyptol...) | Oral administration: all forms Topical administration: skin treatment cream Mouth wash, oromucosal paste |
|
212 | Tioconazol used singly or in combination with Hydrocortisone | Topical administration: all forms with concentration as follows - Tioconazol ≤ 1.00% - Hydrocortisone ≤ 0.05% |
|
213 | Tolnaftate | Topical administration |
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214 | Triclosan used singly or in combination with topical medicines | Topical administration |
|
215 | Triprolidine used singly or in combination in cough suppressants, fever or pain relief medicines | Oral administration: all forms |
|
216 | Trolamine used singly or in combination in topical medicines (with Triclosan and/or Tyrothricin) | Topical administration |
|
217 | Tyrothricin used singly or in combination (with Benzalkonium, Benzocaine, Formaldehyde, Trolamine, essential oil and ingredients contained in essential oil) | Oral administration: lozenges Topical administration: mouthwash solution, spray and skin cream |
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218 | Urea used singly or in combination with Vitamin E and/or Bifonazole and/or herbal ingredients which are not specified in the List of toxic herbal ingredients used for producing pharmaceuticals | Topical administration |
|
219 | Vitamin A and pre-Vitamin A (Betacarotene) used singly and in combination with vitamins | Oral administration: all forms with limited content of Vitamin A ≤ 5000 IU/unit Topical administration Eye drop |
|
220 | Single Vitamin (except for single Vitamin D) or compounds containing Vitamins, minerals, Amino acids, fatty acids, taurine, lutein and Zeaxanthin | Oral administration: all forms Topical administration Oral compounds containing Vitamin A with limited content as follows: Vitamin A ≤ 5000 IU/ metered dosage unit | Medication for Vitamin, mineral and nutrition supplement |
221 | Single or compound Group-B vitamin, Vitamin PP | Eye drop
|
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222 | Bacteria beneficial to digestive health: Bacillus claussi, Bacillus subtilis, Lactobacillus acidophilus in the single or compound form, including those combined with vitamins | Oral administration: all forms |
|
223 | Methylene blue | Topical administration |
|
224 | Xylometazoline used singly or in combination with Benzalkonium. | Nasal drop with limited concentration of Xylometazoline ≤ 1% |
|
2. ORIENTAL MEDICINES AND HERBAL MEDICINES
Oriental or herbal medicines are specified in the List of non-prescription medicines and meet regulations laid down in this Circular.
APPENDIX 03
TEMPLATE OF CERTIFICATE OF APPROVAL FOR ADVERTISEMENT CONTENTS
(Issued together with the Circular No /2015/TT-BYT of the Minister of Health dated ……….., 2015 on providing guidance on advertising activities under the authority of the Ministry of Health)
THE MINISTRY OF HEALTH/THE DEPARTMENT OF HEALTH | THE SOCIALIST REPUBLIC OF VIETNAM |
No.: /XNQC-…(5)… | Name of province/city, ………., 20... |
CERTIFICATE OF APPROVAL FOR ADVERTISEMENT CONTENTS
Name of organization, individual: ....................................................................................
Address: .........................................................................................................
Telephone number: ………………………………..Fax:……………………….
No. | Description of product, commodity or service (specifying type, ....(if any))
| Numerical code of the Certificate of free circulation for product, or the Decision on issuance of the registration number of pharmaceutical product/ Notification of cosmetic product/ Certificate of Declaration of conformity with the food safety regulations or Certificate of Declaration of Conformity/ Certificate of free circulation for chemicals, insecticides, fertilizers used in household appliance and healthcare industry/ Permit for import of medical equipment or Certificate of free circulation for medical equipment/ Permit for healthcare service operations and the Decision on approval for the list of professional practices |
|
|
|
Means of advertising:
(If verbal, pictorial or printing press are used for advertising, please specify the specific title of such press; If seminars, conferences or events are used for advertising, please specify proposed schedule, venue and presenters)
……………………………………………………………………………………………
……………………………………………………………………………………………
Advertisement contents: In conformity with approved attached contents of organization/individual in conformity with applicable regulations.
Organization/ individual shall assume responsibility to conform to approved advertisement contents.
| Approver |
APPENDIX 04
TEMPLATE OF APPLICATION FOR REISSUANCE OF CERTIFICATE OF APPROVAL FOR ADVERTISEMENT CONTENTS
(Issued together with the Circular No /2015/TT-BYT of the Minister of Health dated ………..,2015 on providing guidance on approval for contents of advertisements for special products, commodities and services under the authority of the Ministry of Health)
NAME OF THE APPLICANT | THE SOCIALIST REPUBLIC OF VIETNAM |
No.: /Abbreviated name of the applicant | (6)…, ……………, 20…. |
APPLICATION
Reissuance of the certificate of approval for advertisement contents
Dear: ..........................(7)...................................
1. The applicant’s details:………………………………………………………..
1.1. Name of the applicant:………………………………………………………….
1.2. Office address: (8)…………………………………………………………….
...........................................................................................................................................
Telephone number: ………………………………..Fax:……………………….
The previous Certificate of approval for advertisement contents:…………………..
Issue date:..................................... Issue place:...........................................................
Applies for issuance of the Certificate of approval for advertisement contents for………..
No. | Description of product, commodity or service (specifying type, ....(if any))
| Numerical code of the Cerificate of free circulation for product, or the Decision on issuance of the registration number of pharmaceutical product/ Notification of cosmetic product/ Certificate of Declaration of conformity with the food safety regulations or Certificate of Declaration of Conformity/ Certificate of free circulation for chemicals, insecticides, fertilizers used in household appliance and healthcare industry/ Permit for import of medical equipment or Certificate of free circulation for medical equipment/ Permit for healthcare service operations and the Decision on approval for the list of professional practices |
|
|
|
|
|
|
Means of advertising:
(If verbal, pictorial or printing press are used for advertising, please specify the specific title of such press; If seminars, conferences or events are used for advertising, please specify proposed schedule and venue)
……………………………………………………………………………………………
……………………………………………………………………………………………
Reasons for application for reissuance of the certificate of approval for advertisement contents: (9)………………
……………………………………………………………………………………………
Application including the following documents or materials:
……………………………………………………………………………………………
……………………………………………………………………………………………
I herein undertake all information and documentation mentioned above are genuine and I am committed to advertising product, commodity or service under the authority of the Ministry of Health in accordance with the approved contents.
I am looking forward to your consideration and issuance of approval for the advertisement content./.
| The Director or Legal representative |
(1) Geographical name
(2) The receiving authority: The competent authorities stipulated in Article 12 hereof.
(3) Provide the address printed on the certificate of business registration
(4) Name of the receiving authority
(5) Abbreviation of the authority for approval for advertisement contents
(6) Geographical name
(7) Name of the issuer of the certificate of approval for advertisement contents
(8) Provide the address printed on the certificate of business registration
(9) Specify reasons as stipulated in Article 21 hereof.
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