Some basic notes when registering to advertise drugs

With the rapid spread of information on media and social networks, advertising is playing an important role in business. Through advertising, consumers can easily approach and search for the products. At the same time, companies have the opportunity to find potential customers to promote the purchase demand. Nevertheless, in advertising activities in general and for some specific products such as cosmetics, chemicals, medical equipment and in particular advertising for medicines, legal regulations require that conditions be considered “strict enough” to ensure consumer safety. Accordingly, this article will analyze some key issues relating to the registration of drug advertising content to help operations gain an overview of the topic when implementing them.

Previously, the content of drug advertising was stipulated by (i) the Advertising Act of 2012 and the Guidance Regulations of the Advertising Act and (ii) the Pharmacy Act of 2016 and the Regulations of related guidance. However, from July 1, 2017, the specialized regulations related to the registration of drug advertisements will be uniformly implemented in accordance with the Pharmacy Law and Guidance Regulations, in particular Decree No. 54/2017. / ND-CP guiding the application of the law on pharmacy (hereinafter referred to as “Decree 54/2017”).

For the drug advertising content registration application, applicants should pay attention to 03 main content, which are:

(1) Requirements for the content of drug advertising.

(2) What content should not be provided in the advertising of the drug?

(3) Effect of the drug advertising content certificate.

Specifically:

(1) Requirements for the content of drug advertising

1.1. The content of advertising on medicinal products must comply with the following documents:

a) The label and instructions for use approved by the Ministry of Health;

b) The dissertation on the drug in the national pharmacopoeia of Vietnam;

c) Documents and professional instructions relating to the drug issued or accepted by the Ministry of Health.

Note: Normally, the label used for advertising must be approved by the Drug Administration of Vietnam. In some special cases, applicants can still use the old label. However, the old label used to apply for registration must be attached to the instruction sheet (for patients and medical personnel), which the Vietnam Drug Administration has stamped.

1.2. The content of drug advertising includes the following mandatory information:

1.2.1. General provisions

  1. Drug name;
  2. Active ingredients or herbal ingredients in the approved package insert. The names of the herbal ingredients should be written in Vietnamese. Names of untranslatable foreign herbal ingredients can be written in Latin;
  3. Indications;
  4. Uses;
  5. Dosage;
  6. Contraindications and warnings for particular users (pregnant women, breastfeeding women, children, the elderly, people with chronic diseases);
  7. Precautions and what to avoid when using the drug;
  8. Side effects and adverse effects;
  9. Name and address of manufacturer;
  10. The text “Đọc kỹ hướng dẫn sử dụng trước khi dùng” (“Read the instructions carefully before use”);
  11. The text “Số Giấy xác nhận nội dung quảng cáo thuốc của Bộ Y tế:… / XNQC…, ngày… tháng… năm…; “(” Number and date of the certificate of the content of the drug advertisement issued by the Ministry of Health: … “) at the end of the first page;
  12. The pages of a multi-page document must be numbered. The first page must specify the number of pages and contain the table of contents;
  13. Reference documents and their extracts are specified. Extracts should be accurate without adding or removing information that leads to a misunderstanding of the safety and effectiveness of the drug.

1.2.2. Other regulations

  1. The voice and text in an advertisement for a drug must comply with the law on advertising;
  2. The font size in the content of drug advertisements should be clear, easy to read and recognize, but should not be smaller than the 12 font size of the VnTime or Times New Roman font on A4 paper;
  3. The advertising script must clearly describe the image, text, text and music;
  4. The content of drug advertising should only provide information about the drug, not information unrelated to the drug;
  5. For each specific form of advertising, such as advertising on online newspapers, advertising screens, or advertising is an audio or video track that has multiple pages or sequences, in addition to meeting the general regulations above, applicants must meet and comply with a number of regulations corresponding to each form of advertising.

(2) What content should not be provided in drug advertising?

Information and images that are not authorized for use in advertising content are specified in article 126 of Decree 54/2017.

A common cause of rejection of an advertising record is the use of adjectives, such as fast pain relief. With the word “fast” on the record, the Drug Administration may require the provision of results of drug use to verify that the processing time is faster than that of other identical products. The other cases use a comparative word which is generally the best product; or contain additional phrases such as “root treatment”, “high quality”, “trusted for generations” etc.

(3) Effect of the drug advertising content certificate

The certification of the content of drug advertising does not have a specific expiration date and will be invalidated in the following cases:

  1. The drug registration certificate expires;
  2. The drug registration certificate is revoked;
  3. A change in the drug information is made and requires the issuance of another drug advertisement content certification. Specifically, the drug information certification has been issued, but the applicant for registration of the drug, drug name, ingredients, strength, dosage form, indications, contraindications, dosage, special case uses, warnings or drug safety information are changed;
  4. There is a recommendation from the state management agency in charge of pharmacy on the limitation of use or use under the supervision of medical examination and treatment practitioners;
  5. The drug contains an active ingredient or a herbal ingredient that has been removed from the list of over-the-counter (OTC) drugs promulgated by the Minister of Health.

In particular, in the event of renewal of the drug registration certificate, the certification of the advertising content of the drug will be automatically renewed with the same duration as that of the drug registration certificate.

Perhaps applicants faced with the restrictions of legal regulations will feel hesitant about administrative procedures. On the one hand, from a manufacturer’s point of view, when the manufacturer ensures compliance with the legal provisions and the quality of the product is highly valued by consumers, the manufacturer will have a competitive advantage over its competitors in the market. interior. On the other hand, meeting and complying with legal conditions is also the basis for manufacturers to protect themselves against certain side effects of products. However, it cannot be denied that from the point of view of consumers, they need to be protected because the drug will have a direct impact on health, especially when the drug is indicated for the elderly and children.

About Cedric Lloyd

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