Circular No. 09/2015/TT-BYT stipulates the confirmation of advertising content for special products, goods, and services under the management of the Ministry of Health.

CIRCULAR

Regulations on the confirmation of advertising content for

products, goods,special services under the management of the Ministry of Healthpolicies

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Pursuant to the Advertising Law dated June 21, 2012;

Pursuant to the Food Safety Law dated June 17, 2010;

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

Pursuant to the Chemicals Law on November 21, 2007;

Pursuant to the Drug Law dated June 14, 2005;

Pursuant to Decree No. 181/2013/NĐ-CP dated November 14, 2013 of the Government detailing the implementation of certain provisions of the Advertising Law;

Pursuant to Decree No. 100/2014/NĐ-CP dated November 6, 2014 of the Government on the business and use of nutritional products for infants, baby bottles, and artificial nipples;

Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Legal Department;

The Minister of Health issues this Circular regulating the confirmation of advertising content for products, goods, and special services under the management of the Ministry of Health.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the conditions, authority, files, and procedures for confirming the advertising content for products, goods, and special services under the management of the Ministry of Health, including:

1. Medicines not falling within the prohibited advertising cases as provided for in Clause 5, Article 7 of the Advertising Law.

2. Cosmetics.

3. Foods and food additives under the management of the Ministry of Health, including:

a) Functional foods;

b) Foods fortified with micronutrients;

c) Natural mineral water;

d) Bottled water;

đ) Food additives and food processing aids.

4. Chemicals and insecticides, bactericides used in household and medical fields.

5. Medical devices.

6. Milk and nutritional products for children under the management of the Ministry of Health not falling within the prohibited advertising cases as provided for in Clause 1, Article 7 of the Advertising Law.

7. Medical examination and treatment services.

Article 2. Applicability

This Circular applies to organizations and individuals related to the confirmation of advertising content for products, goods, and special services under the management of the Ministry of Health on the territory of Vietnam.

Article 3. Fees for assessment and fees for issuing and reissuing certificates of confirmed advertising content for products, goods, and special services under the management of the Ministry of Health

1. The entity requesting the confirmation of advertising content shall be responsible for paying the assessment fee and the fee for issuing and reissuing the certificate of confirmed advertising content at the agency receiving the application file for the confirmation of advertising content in accordance with the provisions of the law.

2. For each advertisement sample corresponding to one application file for the confirmation of advertising content, the following fees for assessment and confirmation shall be paid:

a) Cases considered as one application file for the confirmation of advertising content, including:

- One advertisement sample of a product, good, or service for one target group;

- One advertisement sample of a product, good, or service for one target group for multiple advertising forms (for example: flyers, posters, books, newspapers, etc.).

b) Cases not considered as one application file for the confirmation of advertising content, including:

- Multiple advertisement samples of a product, good, or service for one target group. In this case, each advertisement sample is considered as one application file for the confirmation of advertising content;

- One advertisement sample comprising multiple products, goods, or services for one target group. In this case, each product, good, or service is considered as one application file for the confirmation of advertising content.

c) For drug advertisements:

Cases considered as one application file for the confirmation of drug advertising content, including:

- The cases provided for in Point a, Clause 2 of this Article;

- One advertisement sample of a drug with one dosage form for one target group;

- One advertisement sample of two or more drugs with the same active ingredient but different dosages, dosage forms, and routes of administration from the same manufacturer for one target group.

d) For cosmetic advertisements:

Cases considered as one application file for the confirmation of cosmetic advertising content, including:

- The cases provided for in Point a, Clause 2 of this Article;

- One advertisement sample of two or more products corresponding to one registration certificate for cosmetic products that have been accepted.

đ) For food and food additive advertisements:

- Cases considered as one application file for the confirmation of food and food additive advertising content, including:

+ The cases provided for in Point a, Clause 2 of this Article;

+ One advertisement sample for two or more food and food additive products with the same function and target group.

- Cases not considered as one application file for the confirmation of food and food additive advertising content, including:

+ The cases provided for in Point b, Clause 2 of this Article;

+ One advertisement sample for two or more food and food additive products with different groups of functions and target groups. In this case, each product is considered as one application file for the confirmation of advertising content.

Chapter II

Article 4. Conditions, Authority, Files, Procedures for Confirming Advertising Content for Special Products, Goods, Services under the Management of the Ministry of Health

Article 4. General conditions for confirming advertising content

1. Advertising content must comply with the provisions of the Law on Advertising and not include prohibited acts as stipulated in Article 8 of the Law on Advertising.

2. The voice, writing, images in advertisements must be concise, common, and comply with the provisions of Article 18 of the Law on Advertising. The smallest font size in the advertising content must ensure a sufficient ratio to be readable under normal conditions and must not be smaller than the equivalent size of Vntime or Times New Roman 12 on A4 paper.

Article 5. Conditions for confirming advertising content for medicines

Medicines must meet the advertising conditions prescribed in Point a Clause 4 Article 20 of the Law on Advertising, comply with the provisions of Article 3 Decree No. 181/2013/ND-CP dated November 14, 2013 of the Government detailing certain provisions of the Law on Advertising (hereinafter referred to as Decree No. 181/2013/ND-CP), and specific regulations as follows:

1. Medicines permitted to advertise as specified in Clause 1 Article 1 of this Circular include:

a) Medicines listed in the non-prescription drug list and not subject to recommendations by competent state authorities to limit usage or use under medical supervision;

b) In cases of advertising medicines on radio or television, the active ingredient of the medicine must be included in the list of active ingredients of drugs and medicinal materials allowed to be advertised on radio or television as specified in Appendix 02 attached to this Circular.

2. The medicine must have been granted a registration number for circulation in Vietnam which remains valid, and the drug's user guide must have been approved by the Ministry of Health.

3. Must have complete files as prescribed in Article 14 of this Circular.

4. The entity requesting confirmation of advertising content must be the entity named on the product registration certificate for circulation or the representative office in Vietnam of the entity named on the product registration certificate for circulation, or an entity with legal personality authorized in writing by the entity named on the product registration certificate for circulation.

5. The advertising content for medicines must comply with the following regulations:

a) It must be consistent with the documents prescribed in Clause 1 Article 3 of Decree No. 181/2013/ND-CP;

b) It must contain all information prescribed in Clause 2 Article 3 of Decree No. 181/2013/ND-CP and the following information:

- For advertising medicines in books, newspapers, magazines, flyers, additional information such as caution, dosage, method of use must be provided;

- For advertising medicines on radio or television, the content prescribed in Clause 3 Article 3 of Decree No. 181/2013/ND-CP must be clearly read out, and the contents of indications, contraindications, or recommendations for special groups must be ensured to be fully and clearly heard or read by listeners or viewers;

- For advertising on online newspapers, information websites, advertising screens:

+ For advertising content with sound: it must contain information as on radio or television;

+ For advertising content without sound: it must contain information as in books, newspapers, magazines, flyers;

If there are multiple pages/scenes in the advertisement, the pages/scenes of the advertisement must appear consecutively, pause long enough for viewers to read all the information displayed on the page; pages/scenes containing product information must remain stationary, not moving, so that readers can thoroughly understand the product information.

c) Advertising content for medicines on outdoor advertising media must contain all information prescribed in Clause 4 Article 3 of Decree No. 181/2013/ND-CP.

d) Indications not to be included in the advertising content for medicines:

- Indications prescribed in Clause 5 Article 3 of Decree No. 181/2013/ND-CP;

- Treatment indication for viral hepatitis, newly emerging diseases.

đ) Information and images not to be used in advertising medicines include:

- Information and images prescribed in Clause 6 Article 3 of Decree No. 181/2013/ND-CP;

- Exaggerated descriptions of pathological conditions or effects of the medicine;

- Images of animals or plants in the conservation list;

- Information and images creating the impression: using this medicine does not require a doctor's opinion; using this medicine is completely harmless, has no side effects, no contraindications, guarantees 100% effectiveness.

Article 6. Conditions for confirming the content of cosmetic advertisements

1. Cosmetics must meet the advertising conditions prescribed in Point b Clause 4 Article 20 of the Advertising Law.

2. The advertisement content must comply with the provisions of Article 4 Decree No. 181/2013/ND-CP and the following contents:

a) Not to use images, costumes, names, letters, articles of healthcare units, hospitals, doctors, pharmacists, other healthcare staff;

b) The functions and effects of the product must be consistent with the nature of the product, the classification of the product, and the functions and effects already announced according to the law.

3. To have complete documents as stipulated in Article 15 of this Circular.

4. The entity requesting confirmation of the advertisement content must be the entity named on the product announcement form or the representative office in Vietnam of the entity named on the product announcement form, or an entity with legal personality authorized in writing by the entity named on the product announcement form.

Article 7. Conditions for confirming the content of food and food additive advertisements

1. Food products and food additives must have a certificate of conformity announcement for safety (for products without national technical standards) or a receipt of the conformity announcement from the competent state agency.

2. The advertisement content must comply with the provisions of Article 5 Decree No. 181/2013/ND-CP and the following contents:

a) For contents outside those already announced, there must be legal documents, scientific evidence, and clear references to the sources of information in the market, advertisement script; for products with special usage and storage methods, these must be specifically mentioned in the advertisement;

b) For advertisements on boards, signs, billboards, price shelves, scrolling text at the bottom of television programs, on other objects, airborne objects, underwater objects, mobile objects, it is not mandatory to contain all information about usage, effects, and storage, but they must be consistent with the conformity announcement or the safety compliance announcement;

c) It is not allowed to advertise food in the form of articles by doctors, pharmacists, healthcare staff, with content describing food having therapeutic effects;

d) It is not allowed to use images, costumes, names, letters of healthcare units, hospitals, doctors, pharmacists, healthcare staff, patient thank-you letters to advertise food.

3. To have complete documents as stipulated in Article 16 of this Circular.

4. The entity requesting confirmation of the advertisement content must be the entity named on the conformity announcement receipt or the safety compliance announcement (for products without national technical standards), or an entity with legal personality authorized in writing by the entity named on the conformity announcement receipt or the safety compliance announcement.

Article 8. Conditions for confirming the content of chemical and insecticide, bactericide advertisements for household and medical use

1. Must meet the advertising conditions prescribed in Point c Clause 4 Article 20 of the Advertising Law.

2. The advertisement content must comply with the provisions of Article 6 Decree No. 181/2013/ND-CP.

3. To have complete documents as stipulated in Article 17 of this Circular.

4. The entity requesting confirmation of the advertisement content must be the entity named on the product registration circulation certificate or an entity with legal personality authorized in writing by the entity named on the product registration circulation certificate.

Article 9. Conditions for confirming the content of medical device advertising

1. Must meet the advertising conditions prescribed in Point g Clause 4 Article 20 of the Advertising Law.

2. The advertising content must comply with the provisions set out in Article 7 of Decree No. 181/2013/ND-CP.

3. Must have complete files as prescribed in Article 18 of this Circular.

4. The unit requesting confirmation of the advertising content is the unit named on the product registration certificate for domestically produced products or the import permit for imported products or the representative office in Vietnam of the unit named on the import permit or the unit with legal personality authorized in writing by the unit named on the product registration certificate for domestically produced products or the import permit for imported products.

Article 10. Conditions for confirming the content of milk and nutritional products for children advertising

1. Must meet the advertising conditions prescribed in Point d Clause 4 Article 20 of the Advertising Law and have a receipt for the declaration of conformity or a confirmation of compliance with food safety regulations (for products without technical standards) issued by the competent state agency.

2. The advertising content must comply with the provisions set out in Article 8 of Decree No. 181/2013/ND-CP and Clause 2 Article 6 of Decree No. 100/2014/ND-CP dated November 6, 2014 of the Government regarding the business and use of nutritional products for young children, baby bottles and artificial nipples.

3. To have complete documents as stipulated in Article 16 of this Circular.

4. The unit requesting confirmation of the advertising content is the unit named on the receipt for the declaration of conformity or confirmation of compliance with food safety regulations (for products without technical standards) or the unit with legal personality authorized in writing by the unit named on the receipt for the declaration of conformity or confirmation of compliance with food safety regulations.

Article 11. Conditions for confirming the content of medical examination and treatment service advertising

1. Must meet the advertising conditions prescribed in Point e Clause 4 Article 20 of the Advertising Law, specifically as follows:

a) Medical examination and treatment activity permit for medical examination and treatment facilities;

b) Professional practice certificate for medical practitioners required by law to hold such a certificate.

2. The advertising content must comply with the provisions set out in Article 9 of Decree No. 181/2013/ND-CP.

3. Must have complete files as prescribed in Article 19 of this Circular.

4. The unit requesting confirmation of the advertising content is the unit named on the medical examination and treatment activity permit or the unit with legal personality authorized in writing by the unit named on the medical examination and treatment activity permit.

Article 12. Authority to issue certificates confirming the content of advertising within the purview of the Ministry of Health

1. Organizations under the Ministry of Health have the authority to issue certificates confirming the content of advertising:

a) The Drug Administration issues certificates confirming the content of drug advertising as prescribed in Clause 1 Article 1 of this Circular;

b) The Food Safety Administration issues certificates confirming the content of functional food; nutrient-enriched food; milk and nutritional products for children advertising as prescribed in Clause 6 Article 1 of this Circular;

c) The Medical Examination and Treatment Management Administration issues certificates confirming the content of modern medical examination and treatment service advertising of medical examination and treatment facilities licensed and approved for specialized techniques by the Minister of Health;

d) The Traditional Medicine and Pharmaceutical Administration issues certificates confirming the content of traditional medical examination and treatment service advertising of medical examination and treatment facilities licensed and approved for specialized techniques by the Minister of Health;

đ) The Health Environment Management Administration issues certificates confirming the content of advertising for chemicals, insecticides, and bactericides used in household and health care fields;

e) The Medical Equipment and Construction Administration issues certificates confirming the content of medical equipment advertising (on behalf of the Minister of Health).

2. Provincial Departments of Health under the Central Government issue certificates confirming the content of advertising for:

a) Cosmetics of units named on the cosmetic product declaration form with headquarters located within the jurisdiction of the Department of Health; In cases where cosmetics are advertised through conferences, seminars, or events, the provincial Department of Health where the conference, seminar, or event is planned shall issue the certificate confirming the content of the advertising;

b) Medical examination and treatment services of medical examination and treatment facilities licensed and approved for specialized techniques by the Director of the Department of Health.

3. Provincial Food Safety Control Centers under the Central Government have the authority:

a) To issue certificates confirming the content of natural mineral water, bottled drinking water, food additives, and food processing aids advertising;

b) To issue certificates confirming the content of advertising for forms of advertising through conferences, seminars, or events introducing food and food additives as prescribed in Clause 3 Article 1 of this Circular organized within their jurisdiction;

c) To respond to opinions on food advertising content claiming health effects when agencies tasked with issuing or reviewing advertising content for food under the purview of the Ministry of Industry and Trade, the Ministry of Agriculture and Rural Development seek their opinion.

Article 13. General requirements for the dossier requesting confirmation of advertising content for products, goods, and services under the management of the Ministry of Health

1. The dossier shall be made in one set.

2. The dossier shall include the following documents:

a) A request for confirmation of advertising content in accordance with Appendix 01 attached to this Circular;

b) Business registration certificate of the enterprise or representative office establishment permit of foreign traders;

c) Content requested for confirmation of advertising:

- If advertising on radio or television, there must be one copy of the recorded advertising content expected on a disc or audio file, accompanied by three copies of the expected advertising script, clearly describing the expected advertising content, means, images (for television), words, music;

- If advertising on non-radio or non-television media, there must be three copies of the color printout of the expected advertising content, accompanied by a soft file recording the expected advertising content;

- If advertising through seminars, conferences, events: In addition to the documents specified in this point, there must also be the following documents: advertisement samples used in the program that have been approved by the competent authority and are still valid (in cases where the advertisement content has already been approved), the program clearly stating the name of the report content, time (date/month/year), location (specific address); content of the report and presentation materials distributed to participants; list of speakers' names, scientific titles, professional qualifications (speakers must hold relevant professional qualifications appropriate to the field of advertised products, goods, or services. For drug advertisements: speakers must hold pharmaceutical qualifications. For medical examination and treatment service advertisements: speakers must hold medical qualifications appropriate to the field. For food and food additive advertisements: speakers must hold pharmaceutical or related qualifications at bachelor's level or above);

d) Product label sample or product label sample approved by the competent health authority when the law requires the product label to be reviewed by the competent health authority;

3. Other requirements for the dossier:

a) In case the entity requesting confirmation of advertising content is an authorized entity, it must provide the following documents:

- Valid authorization document;

- Business registration certificate or Representative Office Establishment Permit of foreign traders of the authorized entity;

b) Reference materials, evidence, and verification of information in the advertising content:

- Documents in English must be translated into Vietnamese along with the original English documents. The Vietnamese translation must be stamped with the confirmation seal of the entity requesting confirmation of advertising content;

- Documents in foreign languages other than English must be translated into Vietnamese and accompanied by the original foreign language documents. The Vietnamese translation must be notarized in accordance with the law;

c) Documents in the dossier must be printed clearly, arranged in the order prescribed in the provisions of this Circular, separated by colored paper between sections, with a cover page and a list of documents;

d) Documents in the dossier requesting confirmation of advertising content must still be valid, being certified copies or copies stamped by the entity requesting confirmation of advertising content. All documents in the dossier must bear the stamp, overlapping stamp of the entity requesting confirmation of advertising content;

e) The advertising content sample must be presented on A4 size paper. Large outdoor advertising format samples can be presented on A3 size paper or other sizes and clearly indicate the scale ratio compared to the actual size;

4. Requirements for the dossier submitted to the agency providing Level 4 online public services: The dossier must be transferred as a soft file (one copy) and follow the instructions of the agency providing Level 4 online public services.

Article 14. Documents for requesting confirmation of drug advertising content

1. The documents stipulated in Article 13 of this Circular.

2. The drug usage guide that has been approved by the Drug Administration Department under the Ministry of Health.

3. The product circulation permit issued by the Drug Administration Department or the decision on registering the drug number at the Drug Administration Department.

Article 15. Documents for requesting confirmation of cosmetic advertising content

1. The documents stipulated in Article 13 of this Circular.

2. The registration announcement form for cosmetics products that has been issued by the competent state agency.

3. Legitimate and reliable evidence proving the features and functions of the product when the cosmetic advertising content mentions features and functions not included in the registration announcement form for cosmetics products that has been issued by the authority with acceptance number.

Article 16. Documents for requesting confirmation of food, food additives, milk, and nutritional products for children advertising content

1. The documents stipulated in Article 13 of this Circular.

2. The receipt of conformity declaration or the confirmation of compliance with food safety regulations (for products without technical standards) issued by the competent state agency.

3. Detailed information about the product that has been confirmed by the competent authority.

4. Legitimate and reliable evidence proving the features, functions, and information of the product when the advertising content mentions features, functions, and information not included in the detailed information about the product that has been confirmed by the competent authority.

Article 17. Documents for requesting confirmation of chemical substances, insecticides, bactericides advertising content for household and medical use

1. The documents stipulated in Article 13 of this Circular.

2. The registration certificate for circulating chemical substances, insecticides, bactericides.

Article 18. Documents for requesting confirmation of medical equipment advertising content

1. The documents stipulated in Article 13 of this Circular.

2. The import permit for medical equipment or the registration certificate for circulating medical equipment.

Article 19. Documents for requesting confirmation of medical examination and treatment service advertising content

1. The documents stipulated in Article 13 of this Circular.

2. The medical examination and treatment operation permit of the facility providing the advertised services issued by the Minister of Health or the Provincial Health Department Director and the list of specialized techniques approved by the Minister of Health or the Provincial Health Department Director.

3. The medical practice certificate of the person providing the advertised medical examination and treatment services if required by law.

Article 20. Procedures for issuing the confirmation of advertising content certificate

1. The entity requesting confirmation of advertising content submits the application to the agency specified in Article 12 of this Circular (hereinafter referred to as the receiving agency).

2. In case the application is incomplete, within five working days from the date of receiving the application marked with the receiving agency's stamp, the receiving agency will issue a written request for the entity to amend and supplement. The maximum time for the entity to complete the amendment and supplementation of the application according to the requirements is ninety days from the date of receiving the notification letter from the receiving agency. If the deadline is exceeded, the application for confirming the advertising content loses its validity.

3. Within ten working days from the date of receiving the complete and valid application marked with the receiving agency's stamp, the competent state agency issues the confirmation of advertising content certificate according to the model prescribed in Appendix 03 attached to this Circular. In case the confirmation of advertising content certificate is not issued, the competent state agency must provide a written response and clearly state the reasons for non-issuance.

4. The receiving agency is responsible for publishing on its electronic portal the list of products, goods, and services within its jurisdiction that have been issued the confirmation of advertising content certificate or the confirmation of advertising content certificate has expired.

5. For advertising through seminar, conference, event organization forms:

a) At least two working days before conducting the advertising, organizations and individuals with special products, goods, and services under the management of the Ministry of Health who have obtained the confirmation of advertising content certificate from the competent agency of the Ministry of Health for the seminar, conference, event organization forms must submit a written notice about the form, time, and location of the advertising along with a copy of the confirmation of advertising content certificate, the advertisement sample or the approved advertising script to the Health Department where the advertising takes place for inspection and supervision if necessary;

b) In case there is a change in the location or time of the seminar, conference, event organization compared to the content recorded on the confirmation of advertising content certificate, organizations and individuals with advertised products, goods, and services must notify the local Health Department at least two working days before conducting the advertising.

6. The procedure for registering the confirmation of advertising content must be restarted in the following cases:

a) The entity requesting confirmation of advertising content amends and supplements the application not in accordance with the written request for amendment and supplementation of the receiving agency;

b) The entity requesting confirmation of advertising content amends and supplements the application not in accordance with the deadline stipulated in Clause 2 of this Article.

7. Stop accepting applications for confirming the advertising content from entities violating advertising laws until there is a violation handling decision from the competent agency or person and the entity has completed the execution of the handling decision.

Article 21. Reissuing the Certificate of Advertising Content

1. Reissuing the Certificate of Advertising Content in cases of loss or damage:

a) The entity named on the Certificate of Advertising Content or the entity authorized according to regulations shall submit a request for reissue to the competent authority that issued the Certificate of Advertising Content in accordance with the form prescribed in Appendix 04 attached to this Circular;

b) Within five working days from the date of receipt of the request marked with the stamp of receipt of the incoming document by the agency receiving the file, the competent authority shall consider and reissue the Certificate of Advertising Content to the entity. In case of refusal to reissue, the competent authority must issue a notification specifying the reasons.

2. Reissuing the Certificate of Advertising Content in cases where the Certificate of Advertising Content has expired as provided for 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 of this Circular and there is no change in the advertising content:

a) The entity named on the Certificate of Advertising Content or the entity authorized according to regulations shall submit a reissue application file to the competent authority that issued the Certificate of Advertising Content, including the following documents:

- A request for reissuance of the Certificate of Advertising Content in accordance with the form prescribed in Appendix 04 attached to this Circular;

- One of the valid documents corresponding to the product, goods, or service for which the advertising content is requested, as follows:

+ For drug advertisements: Product circulation permit issued by the Drug Administration Department or decision on drug registration number at the Drug Administration Department;

+ For cosmetic advertisements: Notification of cosmetic product declaration already approved by the competent state authority;

+ For food and food additive advertisements: Receipt of conformity declaration or confirmation of compliance with food safety regulations (for products without technical standards) issued by the competent state authority; Detailed information about the product; main label sample already approved by the competent state authority;

+ For chemical, insecticide, and bactericide advertisements for household and medical use: Registration certificate for chemical, insecticide, and bactericide circulation;

+ For medical device advertisements: Medical device import permit or medical device circulation registration certificate.

- The expired Certificate of Advertising Content along with the advertisement script already approved.

b) Within five working days from the date of receipt of the request marked with the stamp of receipt of the incoming document by the agency receiving the file, the competent authority shall consider and reissue the Certificate of Advertising Content to the entity. In case of refusal to reissue the Certificate of Advertising Content, the competent authority must issue a notification specifying the reasons.

3. Reissuing the Certificate of Advertising Content in cases where the Certificate of Advertising Content is still valid but there is a change in the name or address of the organization or individual responsible for bringing the product, goods, or service to the market, without changing the advertising content:

a) The entity named on the Certificate of Advertising Content or the entity authorized according to regulations shall submit a reissue application file to the competent authority that issued the Certificate of Advertising Content, including the following documents:

- A request for reissuance of the Certificate of Advertising Content in accordance with the form prescribed in Appendix 04 attached to this Circular;

- The previously issued Certificate of Advertising Content along with the advertisement script already approved;

- A document from the competent authority regarding the change in the name or address of the organization or individual responsible for bringing the product, goods, or service to the market.

b) The procedure for reissuing the Certificate of Advertising Content shall be carried out in accordance with the provisions of Clauses 2, 3, 4, and 5 of Article 20 of this Circular.

4. Reissuing the Certificate of Advertising Content in cases where the Certificate of Advertising Content has expired as provided for in Article 23 of this Circular but does not fall under the circumstances specified in Clause 2 of this Article, and in cases of changes or additions to the advertising content but do not fall under the circumstances specified in Clause 3 of this Article:

The enterprise must prepare the application file and procedures for registering the Certificate of Advertising Content as in the initial registration case.

5. The application file for reissuing the Certificate of Advertising Content must comply with the requirements stipulated in Clause 3 of Article 13 of this Circular.

Article 22. Format for Recording the Content Confirmation Certificate for Advertising

1. For advertising content confirmed by organizations under the Ministry of Health, the recording principle shall be as follows: registration number/year/Content Confirmation Certificate - abbreviated name of the issuing organization. Example: 123/2015/XNQC-ATTP.

2. For advertising content confirmation certificates issued by the Department of Health or the Food Safety and Hygiene Inspection Agency, the recording principle shall be as follows: registration number/year/Content Confirmation Certificate - abbreviated name of the issuing organization and abbreviated name of the province or centrally-administered city. Example: 123/2015/XNQC-YTHN or 123/2015/XNQC-ATTPHN.

Article 23. Cases Where the Advertising Content Confirmation Certificate Becomes Ineffective

1. Cases where the advertising content confirmation certificate for medicines becomes ineffective:

a) The registration number of the medicine has expired;

b) The medicine has been withdrawn from registration or has been subject to a recommendation by the competent state management agency to limit its use;

c) Changes in information regarding indications, contraindications, or dosage of the medicine.

2. Cases where the advertising content confirmation certificate for cosmetics becomes ineffective:

a) The registration number of the cosmetic product announcement form has become invalid;

b) Cosmetics have been suspended from circulation or recalled or withdrawn from registration;

c) There are changes in information affecting the safety and quality of the cosmetics.

3. Cases where the advertising content confirmation certificate for food, food additives, milk, and nutritional products for children becomes ineffective:

a) The conformity acceptance receipt or the content confirmation certificate for compliance with food safety regulations has become invalid;

b) The enterprise has had its food hygiene and safety certification revoked;

c) The product or goods have undergone changes in composition or function;

d) The product or goods have been suspended from circulation or recalled.

4. Cases where the advertising content confirmation certificate for chemicals, insecticides, and bactericides used in household and medical fields becomes ineffective:

a) The registration certificate for the circulation of chemicals, insecticides, and bactericides used in household and medical fields has become invalid;

b) The product or goods have been suspended from circulation or recalled;

c) The product or goods have undergone changes in composition, function, or other information affecting the safety of the product compared to the registration certificate still in effect issued by the Ministry of Health.

5. Cases where the advertising content confirmation certificate for medical equipment becomes ineffective:

a) The import permit or the product registration certificate has become invalid;

b) The product or goods have been suspended from circulation or recalled.

6. Cases where the advertising content confirmation certificate for medical examination and treatment services becomes ineffective:

a) The medical examination and treatment facility has had its operating license revoked or suspended;

b) The medical examination and treatment facility has had its operating license usage rights revoked according to laws on administrative violations;

c) The medical examination and treatment facility has been reissued an operating license due to changes in its professional scope related to advertised medical examination and treatment services.

7. Other cases as prescribed by law.

Chapter III

IMPLEMENTING PROVISIONS

Article 24. Effective Date

1. This Circular takes effect from July 16, 2015.

2. From the date this Circular takes effect, it abolishes the following documents and provisions:

a) Provisions on drug advertising in Circular No. 13/2009/TT-BYT dated September 1, 2009, guiding the operation of drug information and advertising activities issued by the Minister of Health;

b) Provisions on drug advertising in Circular No. 45/2011/TT-BYT dated December 21, 2011, amending and supplementing some articles of Decision No. 1570/2000/QĐ-BYT dated May 22, 2000, implementing the principles of "Good Laboratory Practice for Pharmaceutical Products"; Decision No. 2701/2001/QĐ-BYT dated June 29, 2001, implementing the principles of "Good Storage Practice for Pharmaceuticals"; Circular No. 06/2004/TT-BYT dated May 28, 2004, guiding pharmaceutical production; Decision No. 3886/2004/QĐ-BYT dated November 13, 2004, implementing the principles and standards of "Good Manufacturing Practice for Pharmaceuticals" recommended by the World Health Organization; Circular No. 13/2009/TT-BYT dated September 1, 2009, guiding drug information and advertising activities; Circular No. 22/2009/TT-BYT dated November 24, 2009, regulating drug registration; Circular No. 47/2010/TT-BYT dated December 29, 2010, guiding the export and import of drugs and direct contact drug packaging;

c) Circular No. 42/2010/TT-BYT dated December 15, 2010, promulgating the list of active ingredients and medicinal materials that can be registered for advertising on radio and television;

d) Provisions on cosmetic advertising in Circular No. 06/2011/TT-BYT dated January 25, 2011, regulating cosmetics management;

e) Circular No. 08/2013/TT-BYT dated March 13, 2013, guiding the advertising of foodstuffs under the jurisdiction of the Ministry of Health.

Article 25. Cross-referenced Provisions

1. In case the referenced documents in this Circular are amended, supplemented, replaced, or abolished, they shall be applied according to the amended, supplemented, replaced, or abolished documents.

2. In cases where certificates, licenses, receipts, confirmation certificates, announcement forms, and drug registration number issuance decisions specified in this Circular are replaced by other types of documents or renamed by competent state authorities, they shall be applied according to the new names of the documents.

Article 26. Transitional Provisions

1. Organizations and individuals who have registered advertising files for special products, goods, and services under the jurisdiction of the Ministry of Health before this Circular takes effect and received an advertising registration receipt from the competent state management authority shall continue to advertise until the advertising registration receipt becomes invalid.

2. For products, goods, and services eligible for online content confirmation certificates through e-government services, the competent authority shall issue such certificates based on this Circular and relevant laws.

Article 27. Responsibility for Implementation

1. The heads of agencies authorized to issue certificates confirming advertising content as stipulated in Article 12 of this Circular shall be responsible for implementing the Circular within their assigned scope and for supervising and monitoring advertising activities after issuing the certificate.

2. The entity requesting confirmation of advertising content shall be responsible for the legality and accuracy of the information and documents in the application dossier and the content of the advertisement.

3. The Heads of the Legal Affairs Department, the Director of the Ministry's Office, the Inspector General of the Ministry, the Heads of Departments, Directors of Bureaus, and Directors of General Departments under the Ministry of Health; the Directors of Provincial Health Services, the Chiefs of Food Safety Inspection Subdivisions under provinces and centrally governed cities, and related organizations and individuals shall be responsible for enforcing this Circular. In case of difficulties during implementation, agencies, organizations, and individuals shall report to the Ministry of Health for study and resolution.

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals shall report to the Ministry of Health for study and resolution./.