THIÊN DI PROVIDES DRUG ADVERTISING PERMIT SERVICES

1. What is a drug? What is drug advertising?

2. Legal Basis

• Law on Advertising No. 16/2012/QH13
• Law on Pharmacy No. 105/2016/QH13
• Decree No. 181/2013/NĐ-CP detailing the implementation of some articles of the Law on Advertising.
• Decree No. 54/2017/NĐ-CP detailing some articles and measures for the implementation of the Law on Pharmacy.
• Circular No. 09/2015/TT-BYT stipulating the confirmation of advertising content for products, goods, and services specifically managed by the Ministry of Health.

3. Why is it necessary to obtain a drug advertising license?

4. General Conditions for Advertising and Granting Drug Advertising Licenses

4.1. Conditions for Drug Advertising

• Drug registration entity in Vietnam;
• Representative office in Vietnam of the foreign entity registering the drug in Vietnam and authorized by the entity;
• Vietnamese pharmaceutical business entity authorized by the drug registration entity in Vietnam.

• Belong to the Over-the-counter Drug List;
• Not subject to restrictions on use or use under the supervision of a doctor according to the recommendations of the competent state agency;
• The drug registration certificate is still valid in Vietnam.

• Current label and package insert approved by the Ministry of Health;
• Monograph on drugs listed in the Vietnamese National Pharmacopoeia;
• Relevant documents and professional instructions on drugs issued or recognized by the Ministry of Health.

• Drug name;
• Pharmaceutical or herbal ingredients listed in the approved package insert. For herbal medicines, the Vietnamese name must be written; if there is no Vietnamese name, the Latin name must be written;
• Indication;
• How to use;
• Dosage;
• Contraindications; warnings for special subjects (pregnant women; breastfeeding women; children; elderly people; people with chronic diseases);
• Precautions and things to avoid, notes when using the drug;

4.2. General Conditions for Granting Advertising License for Pharmaceuticals:

• The content of pharmaceutical advertising must comply with all legal regulations on advertising and avoid any prohibited acts as specified in Article 8 of the Law on Advertising.
• Documents must be printed on A4 paper size. For large-scale outdoor advertising, the content of pharmaceutical advertising can be presented on A3 paper size and clearly state the size ratio compared to the actual size. All documents in the file must have the official seal of the establishment requesting confirmation of the pharmaceutical advertising content. In case the design of the advertising object has a spatial structure, the file must have a description on A3 paper of the following mandatory contents:
• Spatial structure;
• Numbering the sides, size of each side;
• Size ratio of the design sample to the actual sample.

5. Types of Pharmaceuticals Granted Advertising License:

• Pharmaceuticals included in the list of over-the-counter drugs and not recommended by competent state agencies for restricted use or use under the supervision of a doctor;
• In case of advertising pharmaceuticals on newspapers and television, the pharmaceutical must have the main active ingredient included in the list of active pharmaceutical ingredients and medicinal herbs allowed for advertising on newspapers and television as specified in Appendix 02 issued together with Circular 09/2015/TT-BYT.
• Pharmaceuticals that have been granted a valid registration number for circulation in Vietnam and the instructions for use of the drug have been approved by the Ministry of Health.
• Complete application for advertising license for pharmaceuticals.
• The requesting unit for confirmation of advertising content must be the unit named on the certificate of registration for circulation of the product or the representative office in Vietnam of the unit named on the certificate of registration for circulation of the product or a legal entity authorized by the unit named on the certificate of registration for circulation of the product in writing.

6. Methods of Drug Advertisement

7. Instructions on the Procedure for Obtaining a Drug Advertisement License

8. Procedures for Applying for a Drug Advertising License

8.1. Application for a Drug Advertising License

• Application for confirmation of drug advertising content according to Form No. 01 in Appendix VI issued with this Decree;
• The designed sample of the drug advertising content to be confirmed; audio and video recording of the advertising content on the media of newspapers, television, or electronic devices, specialized advertising screens, and other advertising media as prescribed by law on advertising with sound and moving images;
• The current sample of drug label and instructions for use approved by the Ministry of Health;
• Reference documents related to the drug advertising content to be confirmed (if any);
• Drug registration certificate;
• Certificate of establishment of a representative office of a foreign company in Vietnam for a foreign entity applying for confirmation of drug advertising content or Certificate of eligibility for pharmaceutical business for a Vietnamese pharmaceutical business applying for confirmation of drug advertising content;
• Power of attorney of the drug registration entity for the entity named in the application file for confirmation of drug advertising content in case of authorization.

• Application for confirmation of drug advertising content according to Form No. 02 in Appendix VI issued with this Decree;
• Drug advertising content;
• The current sample of drug label and instructions for use approved by the Ministry of Health;
• Reference documents related to the drug advertising content to be confirmed (if any);
• Drug registration certificate;
• Certificate of establishment of a representative office of a foreign company in Vietnam for a foreign entity applying for confirmation of drug advertising content or Certificate of eligibility for pharmaceutical business for a Vietnamese pharmaceutical business applying for confirmation of drug advertising content;
• Power of attorney of the drug registration entity for the entity named in the application file for confirmation of drug advertising content in case of authorization; Notarized copy of the business registration certificate with the pharmaceutical business line.
• Expected program of the seminar, conference, or drug introduction event.

8.2. Requirements for a Drug Advertising License Application File

• Submit the original and 2 copies of the drug advertising content.
• Submit the original or certified copies of other documents.
• 01 design sample or audio and video recording of the drug advertising content for the file specified in Clause 1, Article 121 of Decree 54/2017/ND-CP or 01 drug advertising content for the file specified in Clause 2, Article 121 of Decree 54/2017/ND-CP for one drug;
• 01 design sample or audio and video recording of the drug advertising content for the file specified in Clause 1, Article 121 of Decree 54/2017/ND-CP or 01 drug advertising content for the file specified in Clause 2, Article 121 of Decree 54/2017/ND-CP for two or more drugs with the same active ingredient and route of administration of the same manufacturer but different in content or dosage form;
• Documents are printed on A4 size paper. For large-format outdoor advertising, the drug advertising content can be presented on A3 paper and clearly state the size ratio compared to the actual size. All documents in the file must have the seal of the entity requesting confirmation of the drug advertising content. In case the design of the advertising object has a spatial structure, the file must have a description on A3 paper of the following mandatory contents:
• Spatial structure;
• Numbering the sides, size of each side;
• The size ratio of the design sample to the actual sample.

8.3. Authority to Grant Drug Advertising License

8.4. Processing Time

• Drug advertising content confirmation certificate is lost or damaged;
• The information stated on the Drug Advertising Content Confirmation Certificate is incorrectly recorded due to the fault of the issuing agency.

10. Reapplying for a Drug Advertising License

• Application for Re-issuance of Drug Advertising Content Confirmation, following Form No. 03 in Appendix VI of Decree 54/2017/NĐ-CP.
• Design samples, recordings, or video recordings of the drug advertising content, or the drug advertising content for which a re-issued Confirmation is requested.
• Confirmation of drug advertising content incorrectly recorded due to the fault of the issuing agency, in the case specified in Point b, Clause 2, Article 120 of this Decree.

• Drug advertising content must comply with the following documents:
• Current drug label and leaflet approved by the Ministry of Health;
• Drug monograph in the Vietnam National Pharmacopoeia;
• Related documents and professional instructions on drugs issued or recognized by the Ministry of Health.
• Drug advertising content must include the following mandatory information:
• Drug name;
• Pharmaceutical ingredients or herbal ingredients listed in the approved drug leaflet. For herbal medicines, the Vietnamese name must be written; if there is no Vietnamese name, the Latin name must be written;
• Indications;
• Dosage and administration;
• Contraindications, warnings for special subjects (pregnant women, breastfeeding women, children, elderly people, people with chronic diseases);
• Precautions and things to avoid and note when using the drug;
• Side effects and adverse reactions;
• Name and address of the drug manufacturing establishment;
• Instructions to "Read the instructions carefully before use";
• The top page of the drug advertising content must clearly state: Ministry of Health's Drug Advertising Content Confirmation Number: .../XNQC..., date ... month ... year...;
• For advertising content consisting of multiple pages, the pages must be numbered, and the first page must clearly state the number of pages in this document and the page where detailed product information can be found;
• Drug advertising content must clearly cite the supporting documents and must specify the information quoted in the supporting documents. The citation must ensure accurate transmission of information, without speculation or truncation of information in a way that misleads about the safety and efficacy of the drug.
• Drug advertising content on radio and television must have all the required information. In case the drug composition contains 03 or more active ingredients, each active ingredient must be read or the common name of the vitamin, mineral, and herbal groups must be read.
• Advertising content on electronic newspapers, electronic information websites, electronic devices, dedicated advertising screens and other advertising media according to advertising law regulations:
• Advertising content with sound must present the advertising content as for radio and television as prescribed
• Advertising content without sound must have all the required information

• Drug advertising content through outdoor advertising media is only displayed on 01 side of the advertising medium and must have the information specified in points a, b, i, k and l, Clause 2, Article 125/NĐ-CP. In case the advertising content provides information related to the uses, effects, and indications of the drug, it is mandatory to provide complete information as prescribed in Clause 2, Article 125 of Decree 54/2017/NĐ-CP
• The voice and writing in the drug advertising content must comply with the provisions of the Advertising Law.
• The font size in drug advertising content must be clear, easy to read and easy to recognize, but not smaller than font size 12 of VnTime or Times New Roman font on A4 paper.
• The advertising script must clearly describe the image, narration, text, and music sections.
• Drug advertising content may only provide information about the drug and not provide information unrelated to the drug.

11. Information and Images Not Allowed in Pharmaceutical Advertising

• Information and images that mislead about the composition, effects, indications, and origin of the drug.
• Content creating the following understanding:
  • This drug is the best.
  • This drug is better than all others.
  • Using this drug is the best solution.
  • This drug can be used without consulting a doctor.
  • This drug is completely harmless.
  • This drug has no contraindications.
  • This drug has no unwanted or harmful effects.
• Sentences, words, and images that over-interpret the effects, indications, and efficacy of the drug or exceed the approved effects, indications, and efficacy.
• Listing the effects of each component in the drug to over-advertise the drug's benefits or confuse the effects of each component with the drug's effects.
• Phrases and expressions:
  • "Curing the root cause"
  • "Eradicating"
  • "Specializing in treating"
  • "Leading"
  • "Top-notch"
  • "First-hand"
  • "Choice"
  • "High quality"
  • "100% guaranteed"
  • "Safe"
  • "Ending"
  • "Cutting off"
  • "Stopping"
  • "Reducing immediately"
  • "Reducing instantly"
  • "Curing immediately"
  • "Curing completely"
  • "Reassured"
  • "Don't worry"
  • "No need to worry"
  • "Recommended"
  • "Hotline"
  • "Consulting phone number"
• Similar phrases and expressions.

• Indications for the treatment of tuberculosis and leprosy.
• Indications for the treatment of sexually transmitted diseases.
• Indications for the treatment of insomnia.
• Indications of a sexual nature.
• Indications for the treatment of cancer and tumors.
• Indications for the treatment of drug withdrawal.
• Indications for the treatment of diabetes or other similar metabolic disorders.
• Indications for the treatment of viral hepatitis and other emerging dangerous diseases.

• Test results for the quality of drugs and pharmaceutical ingredients.
• Preclinical research results.
• Clinical research results or bioequivalence test results not recognized by the Ministry of Health.
• Using the name, position, reputation, credibility, or thank-you letters of organizations or individuals to advertise drugs.
• Taking advantage of the origin of drugs or pharmaceutical ingredients to advertise drugs.
• Images, names, and symbols of healthcare professionals.
• Images of animals and plants that are endangered, rare, and prioritized for protection.
• Sentences and words that suggest or recommend the use of the drug.
• Using images of patients to describe the disease state or the drug's effects that are not in line with the drug's documentation and professional guidelines issued or recognized by the Ministry of Health.

12. Cases Where a Drug Advertising License Becomes Invalid

• The drug's registration certificate expires.
• The drug's registration certificate is revoked.
• Information changes, requiring the issuance of a new DAL as specified in Point b, Clause 1, Article 120 of Decree 54/2017/NĐ-CP.
• The drug regulatory authority recommends restricting the drug's use or requiring its use under the supervision of healthcare professionals.
• The drug contains an active ingredient or medicinal herb that is removed from the List of Over-the-Counter Drugs issued by the Minister of Health.

13. LICENSING FOR DRUG ADVERTISEMENT WITH THIÊN DI

13.1. Consultation for Drug Advertisement Licensing at Thiên Di:

• Free consultation on issues related to the licensing process, including:
  • Regulations on drug advertisement licensing.
  • Licensing procedures.
  • Preparing application documents.
  • Other related issues.

13.2. Information Required from Clients:

• Business information
• Advertising type
• Name of the drug to be advertised

13.3. Required Documents:

• 2 original copies of the proposed drug advertisement content design for confirmation; audio or video recording of the advertisement content on newspapers, television, or electronic devices, advertising screens, and other advertising media according to advertising regulations with sound and moving images;
• A copy of the current drug label and leaflet approved by the Ministry of Health;
• Reference materials related to the proposed drug advertisement content (if any);
• A copy of the drug circulation registration certificate;
• A copy of the certificate of eligibility for pharmaceutical business/ A certified copy of the business registration certificate of the representative office/ Original or certified copy of the power of attorney of the drug registration establishment for the establishment named in the drug advertisement content confirmation application file.
  

• Trademark registration
• Trademark registration procedures
• Exclusive product registration
• Product exclusivity registration
• Intellectual property registration of trademarks
• Trademark and logo registration
• Trademark registration at the Intellectual Property Office
• Trademark registration at the Intellectual Property Office
• Food trademark registration
• Cosmetic registration
• Industrial design registration
• Copyright registration
• Service of applying for import license of medical equipment
• Import license for medical equipment and devices
• Procedures for importing medical equipment and devices
• Applying for import license of medical equipment
• ...

 

Sign up for a consultation