Granting certification of drug advertisement content

Currently, drug advertisements in the media are being widely carried out. However, the drug is a special product. To advertise drugs, organizations, and individuals must meet certain conditions and be licensed by a competent authority. In this article, Viet An Law will introduce information about the procedures for granting certification of drug advertisement content in Vietnam.

Legal basis

• Law on Advertisement 2012, as amended and supplemented in 2018;
• Law on Pharmacy 2016, as amended and supplemented in 2018;
• Decree 54/2017/ND-CP details several articles and measures to implement the Pharmacy Law, as amended and supplemented by Decree 155/2018/ND-CP, Decree 88/2023/ND-CP;
• Circular 09/2015/TT-BYT regulating the confirmation of advertisement content for special products, goods, and services under the management of the Ministry of Health, as amended and supplemented by Circular 25/2018/TT-BYT.

Regulations on drug advertisement in Vietnam

Drug advertisement is the use of media to introduce medicine products to the public. Drug advertisements may be for profit or non-profit purposes.

According to the provisions of Article 7 of the Law on Advertisement 2012, prescription drugs and non-prescription drugs that are recommended by competent state agencies to limit use or to be used under the supervision of a physician are on the list of products prohibited in advertisement.

Currently, the law allows advertisement of drugs on the List of non-prescription drugs. However, advertisements must comply with legal regulations. Drug advertisement is carried out by the provisions of Article 79 of the Pharmacy Law 2016 and is carried out according to the advertisement content confirmed by the Ministry of Health and complies with the provisions of the law on advertisement as follows:

• The drug is on the List of non-prescription drugs;
• The drug is not subject to restricted use or must be used under the supervision of a physician as recommended by a competent authority;
• The drug has a valid drug registration certificate in Vietnam.

Conditions for registration drug advertisement content

According to the provisions in Article 4 and Article 5 of Circular 09/2015/TT-BYT, the conditions for confirming drug advertisement content are:

• Advertisement content must comply with legal regulations on advertisement and contain no prohibited acts;
• Voice, writing, and images in advertisement must be concise, common, and by regulations: The smallest font size in advertisement content must ensure a ratio large enough to be readable under normal and irregular conditions. must be smaller than the equivalent of Vntime or Times New Roman 12 font size on A4 paper size.

In addition, to be granted drug advertisement certification, the following conditions must also be met:

• Advertised drugs include: The drug is on the list of non-prescription drugs and is not recommended by a competent state agency to limit use or to be used under the supervision of a physician; When advertising drugs on audio or video newspapers, the drug must have the main active ingredient in the list of active drug ingredients and medicine herbs advertised on audio or video newspapers.
• The drug has been granted a valid registration number for circulation in Vietnam and the drug instruction sheet has been approved by the Ministry of Health.
• Have enough documents according to regulations;
• The unit requesting confirmation of advertisement content is the unit named on the product circulation registration certificate or the representative office in Vietnam of the unit named on the product circulation registration certificate or the unit with legal status authorized in writing by the unit named on the product circulation registration certificate.
• Drug advertisement content must comply with regulations.

What is a Certification of drug advertisement content?

Certificate of drug advertisement content is a document issued by a competent authority to entities wishing to advertise drugs when certain conditions are met. When meeting the prescribed conditions and having a need to advertise drugs, organizations and individuals provide registration documents, the registration agency will evaluate the documents and issue a Certificate of drug advertisement content to the organization. organization or individual if the dossier is complete and valid.

The Certificate of Drug advertisement content does not state the validity period but expires in the following cases:

• The drug circulation registration certificate expires (if the drug circulation registration certificate is renewed, the drug advertisement content confirmation certificate will be automatically renewed);
• The drug has its circulation registration certificate revoked;
• Changing information leads to a case where a Certificate of drug advertisement content must be issued;
• There is a recommendation from the state pharmacy management agency to limit use or use under the supervision of medical examination and treatment practitioners;
• Drugs containing active ingredients or medicine herbs are removed from the List of non-prescription drugs.

Granting certification of drug advertisement content

According to the provisions of Article 120 of Decree 54/2017/ND-CP amended and supplemented by Decree 155/2018/ND-CP, organizations, and individuals are granted Certificates of drug advertisement content in schools. the following:

• Content of drug advertisement requested for first-time certification;
• The drug advertisement content has been granted a Certificate but there are changes in the drug registration basis, drug name, ingredients, concentration or content, dosage form, indications, contraindications, dosage, method of use, drug use in special subjects, information related to warnings and drug safety.

Application for Granting certification of drug advertisement content

Application for issuance of Certificate of drug advertisement content:

• Application for confirmation of drug advertisement content (Form No. 01 in Appendix VI of Decree 54/2017/ND-CP);
• Sample design of drug advertisement content requested for confirmation; audio and video recordings of advertisement content on audio and visual media, electronic devices, advertisement screens, and other advertisement media;
• Current drug labels and instructions for use have been approved by the Ministry of Health;
• Reference documents related to drug advertisement content requested for confirmation;
• Authorization letter from the drug registration facility for the facility whose name is on the dossier requesting confirmation of drug advertisement content in case of authorization.
• One of the following 3 types of documents:
• License to establish a representative office of a foreign company in Vietnam (foreign establishment’s name requests confirmation of drug advertisement content);
• Certificate of eligibility for pharmacy business (Vietnamese pharmacy business establishment requests confirmation of drug advertisement content).
• Exemption from submitting the Certificate of eligibility for pharmacy business issued by the Ministry of Health for Vietnamese pharmacy business establishments requesting certification of drug advertisement content.

Application for issuance of Certificate of drug advertisement content through the means of organizing seminars, conferences, and events

• Application for confirmation of drug advertisement content according to Form No. 02 in Appendix VI of Decree 54/2017/ND-CP;
• Drug advertisement content;
• Current drug labels and instructions for use have been approved by the Ministry of Health;
• Reference documents related to the drug advertisement content requested for confirmation;
• Authorization letter from the drug registration facility for the facility whose name is on the application for confirmation of drug advertisement content in case of authorization;
• The program includes seminars, conferences, and drug introduction events;
• One of the following documents:
• License to establish a representative office of a foreign company in Vietnam (foreign establishment’s name requests confirmation of drug advertisement content);
• Certificate of eligibility for pharmacy business (Vietnamese pharmacy business establishment requests confirmation of drug advertisement content).
• Exemption from submitting the Certificate of Eligibility for pharmacy business issued by the Ministry of Health for Vietnamese pharmacy business establishments requesting certification of drug advertisement content.

Procedures for certification of drug advertisement content

Step 1: Submit application

The facility applying for a Certificate of drug advertisement content prepares documents and submits them to the Ministry of Health.

Step 2: Receive and process documents

Within 10 days from the date of receiving complete documents, the receiving agency will check the documents.

• If the application is valid: issue a Certificate;
• If the dossier is not valid: do not issue the Certificate, the agency receiving the dossier must respond in writing and clearly state the reason for not issuing it.
• If there is a request to amend or supplement the dossier, within 10 days from the date of receiving the complete dossier, the dossier-receiving agency shall send a written request to the establishment to amend and supplement the specific and detailed details of the dossier. Documents and content need to be revised and supplemented:
• Within 10 days from the date of receipt of the amended or supplemented dossier as requested, the agency receiving the dossier shall issue a Confirmation or reply in writing not to issue a confirmation, clearly stating the reason;
• Within 90 days from the date the dossier-receiving agency issues a written notification of amendments and supplements, the facility must submit the amended and supplemented dossiers as requested. If the above deadline is exceeded, the submitted application is no longer valid.

Consulting services on procedures for granting certificates of drug advertisement content from Viet An Law

• Support in consulting on regulations related to drug advertisement activities;
• Support customers in preparing documents and drafting dossiers for certification of drug advertisement content;
• Support customers in submitting applications for certification of drug advertisement content;
• Other legal services upon customer request.

If you have questions related to drug advertisement, please contact Viet An Law Firm for the best support from our team of lawyers!