According to Beijing Youth Daily, a pharmaceutical chain company recently published a drug advertisement on its WeChat public account, and received a fine of 5,000 yuan from the Beijing Dongcheng District Market Supervision Administration for illegally using the words "store manager's recommendation".
During the supervision and inspection, the Dongcheng District Market Supervision Bureau found that a pharmaceutical chain company had published an advertisement on its WeChat public account for "Heat Relief Special - Huo Xiang Zhengqi Soft Capsules", and used the words "recommended by the store manager" in the advertisement.
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The law enforcement personnel said that the above-mentioned conduct of the parties violated the provisions of Article 11 (6) of the Interim Measures for the Review and Administration of Advertisements for Drugs, Medical Devices, Health Foods, and Formula Foods for Special Medical Purposes, and was an act of drug advertisements containing comprehensive evaluation content such as "recommendations". In accordance with Article 28 of the Interim Measures, the Dongcheng District Market Supervision Bureau ordered the parties to stop publishing the advertisement and imposed a fine of 5,000 yuan.
The Interim Measures stipulate a number of prohibited circumstances for advertisements of drugs, medical devices, health foods and formula foods for special medical purposes.
The names or images of state organs, functionaries of state organs, military units, or military personnel must not be used or covertly used, or military equipment or facilities must not be used to engage in advertising and publicity; The names or images of scientific research units, academic institutions, industry associations, experts, scholars, physicians, pharmacists, clinical dietitians, patients, etc. must not be used for recommendation or certification.
It must not violate scientific laws by explicitly or implicitly that it can treat all diseases, adapt to all symptoms, adapt to all people, or be necessary for normal life and treatment of diseases.
It must not contain "safe", "safe and non-toxic side effects", "small toxic side effects" and other content; Do not explicitly or imply that the ingredients are "natural" and therefore safe as such.
It must not contain inducing content such as "hot sale, rush purchase, trial", "family must-have, free treatment, free gift", comprehensive evaluation content such as "evaluation, ranking, recommendation, designation, selection, and award", "invalid refund, insurance company insurance" and other guaranteed content, and content that encourages consumers to arbitrarily and excessively use drugs, health foods, and formula foods for special medical purposes.
On March 1, 2020, the "Interim Measures for the Review and Administration of Advertisements for Drugs, Medical Devices, Health Foods, and Formula Foods for Special Medical Purposes" came into force. The Measures consist of 34 articles, which systematically and comprehensively stipulate the review procedures, release requirements and legal liabilities of advertisements for "three products and one device".
1. What is the scope of review for the "three products and one device" advertisement?
The Interim Measures for the Review and Administration of Advertisements for Advertisements for Drugs, Medical Devices, Health Foods and Formula Foods for Special Medical Purposes (Order No. 21 of the State Administration for Market Regulation, hereinafter referred to as the Measures) shall apply to the review of advertisements for drugs, medical devices, health foods and formula foods for special medical purposes.
Where advertisements for drugs, medical devices, health foods, and formula foods for special medical purposes only advertise product names (including generic names of drugs and drug trade names), their content will no longer be reviewed.
(Refer to Articles 2 and 23 of Order No. 21 of the Measures)
2. Who are the applicants for drugs, medical devices, health foods, and formula foods for special medical purposes?
The holders of registration certificates or filing certificates for drugs, medical devices, health foods and formula foods for special medical purposes and the production and operation enterprises authorized and agreed to them shall be the advertising applicants (hereinafter referred to as the applicants).
The applicant may entrust an agent to handle the application for review of advertisements for drugs, medical devices, health foods and formula foods for special medical purposes.
(Refer to Article 12 of Order No. 21 of the Measures)
3. How to determine the place of approval for drugs, medical devices, health foods, and formula foods for special medical purposes?
Applications for review of advertisements for drugs and formula foods for special medical purposes shall be submitted to the advertising review authority in the place where the advertiser is located, such as the manufacturer or import agent, in accordance with law.
Applications for review of advertisements for medical devices and health foods shall be submitted to the advertising review authority where the manufacturer or import agent is located in accordance with law.
(Refer to Article 13 of Order No. 21 of the Measures)
4. What materials should be submitted to apply for the approval number of advertisements for drugs, medical devices, health foods, and formula foods for special medical purposes?
(1) Submitting the "Advertisement Review Form" in accordance with law, and sample advertisements consistent with the published content;
(2) Materials related to the applicant's subject qualifications, or lawful and valid registration documents; (Business license is required for business operations)
(3) Product registration certificates or filing certificates;
(4) Product labels registered or filed with product registration certification documents;
(5) Product manual;
(6) Production license documents;
(7) Valid proof materials related to intellectual property rights involved in the advertisement.
Production and operation enterprises that have been authorized to act as applicants shall also submit legal authorization documents; Where an agent is entrusted to make an application, a power of attorney and materials related to the agent's qualifications shall also be submitted.
(Refer to Article 14 of Order No. 21 of the Measures)
5. What are the precautions and mandatory items for drug advertising content?
The content of drug advertisements shall be subject to the instructions approved by the drug regulatory department under the State Council. Where drug advertisements involve the name of the drug, the indications of the drug, or the functional indications, pharmacological effects, etc., they must not exceed the scope of the instructions.
Required items for drug advertising:
Conspicuous indication of contraindications and adverse reactions;
Advertisements for prescription drugs should also prominently indicate "This advertisement is for medical and pharmaceutical professionals only", and advertisements for over-the-counter drugs should also prominently indicate the over-the-counter drug label (OTC) and "Please purchase and use according to the drug instructions or under the guidance of a pharmacist".
Reserved advertising approval number: Zhejiang Medicine Guang Review ( ) No.
(Refer to Articles 5 and 9 of Order No. 21 of the Measures)
6. What are the precautions and mandatory items for medical device advertising content?
The content of medical device advertisements shall be subject to the registration certificate or filing certificate approved by the drug regulatory department, and the content of the product manual for registration or filing. Where a medical device advertisement involves the name, scope of application, mechanism of action, or structure and composition of the medical device, it must not exceed the scope of the registration certificate or filing certificate, or the registered or filed product manual.
Required items for medical device advertising:
Advertisements for medical devices recommended for personal use shall clearly indicate "Please read the product manual carefully or purchase and use it under the guidance of medical personnel".
If there are taboo contents or precautions in the medical device product registration certificate, the advertisement shall be conspicuously marked with "see the instruction manual for the prohibited content or precautions for details".
Reserved advertising approval number: Zhejiang Machinery Guangxi ( ) No.
(Refer to Articles 6 and 9 of Order No. 21 of the Measures)
7. What are the points to note and mandatory items in health food advertising?
The content of health food advertisements shall be subject to the registration certificate or filing certificate approved by the market regulatory department, and the content of the registered or filed product manual, and shall not involve disease prevention or treatment functions. Where the advertisement of health food involves health care functions, product functional ingredients or iconic ingredients and content, suitable groups of people or consumption amounts, etc., it must not exceed the scope of the registration certificate or filing certificate, or the registered or filed product manual.
Required items for health food advertising:
(1) Health food advertisements shall clearly indicate that "health food is not a drug and cannot replace the treatment of diseases";
(2) The advertisement is marked "this product cannot replace the drug";
(3) Conspicuously marking the health food logo;
(4) Conspicuously indicate the suitable and unsuitable groups of health food.
(5) Reserved advertising approval number: Zhejiang Food Health Guang Review () No.
(Refer to Articles 7 and 9 of Order No. 21 of the Measures)
8. What are the precautions and mandatory items in the advertising content of formula food for special medical purposes?
The content of advertisements for formula foods for special medical purposes shall be subject to the registration certificate approved by the State Administration for Market Regulation and the product labels and instructions. Where advertisements for formula foods for special medical purposes involve product names, formulas, nutritional characteristics, applicable populations, etc., they must not exceed the scope of registration certificates, product labels, and instructions.
Required items for advertising formula foods for special medical purposes:
The applicable population should be conspicuously marked;
Clearly marked "not suitable for use by non-target groups";
Clearly marked "Please use under the guidance of a doctor or clinical dietitian".
Reserved advertising approval number: Zhejiang Food Special Guang Review () No.
(Refer to Articles 8 and 9 of Order No. 21 of the Measures)
9. What are the acceptance and approval procedures for advertisements for drugs, medical devices, health foods, and formula foods for special medical purposes?
After the advertising review organs receive the application submitted by the applicant, they shall make a decision on acceptance or inadmissibility within five working days. Where the application materials are complete and comply with the legally-prescribed form, it shall be accepted and a Notice of Acceptance of Advertisement Review shall be issued. Where the application materials are incomplete or do not conform to the legally-prescribed form, the applicant shall be informed of all the contents that need to be corrected at one time.
The advertising review organs shall review the materials submitted by the applicant, and complete the review work within 10 working days of acceptance. After review, a decision to review and approve advertisements that comply with laws, administrative regulations, and these Measures shall be made, and an advertisement approval document number shall be compiled and issued. For advertisements that do not comply with laws, administrative regulations, and the provisions of these Measures, a decision not to approve shall be made, served on the applicant with the reasons, and informed that they enjoy the right to apply for administrative reconsideration or initiate administrative litigation in accordance with law.
(Refer to Articles 15 and 16 of Order No. 21 of the Measures)
10. How to adjust the advertising approval ID number?
The new rules for the approval number of advertisements for drugs, medical devices, health foods and formula foods for special medical purposes are "X Drug/Device/Food/Food Guangguang Review (Video/Sound/Text) No. 000000-00000". where "X" is the abbreviation of each province, autonomous region and municipality directly under the Central Government; "Medicine", "Equipment", "Food Health" and "Food Special" are product classifications; "Video", "sound" and "text" are the classification of advertising media forms; "0" consists of 11 digits, the first 6 digits represent the expiration date of the advertisement approval document number (only the last 2 digits are displayed in the year), and the last 5 digits represent the advertisement approval serial number.
11. How to determine the validity period of the advertising approval number of drugs, medical devices, health foods, and formula foods for special medical purposes?
The validity period of the advertising approval number of drugs, medical devices, health food and formula food for special medical purposes is consistent with the shortest validity period of product registration certificate, filing certificate or production license document. If the product registration certificate, filing certificate or production license document does not stipulate the validity period, the advertising approval number is valid for two years.
(Refer to Article 18 of Order No. 21 of the Measures)
12. What are the requirements for the content that should be clearly marked in the "three products and one device" advertisement in the audio and video advertisement?
Content that should be prominently marked in advertisements for pharmaceuticals, medical devices, health foods, and formula foods for special medical purposes must be clearly visible and easily recognizable, and should be continuously displayed in video ads. Content conspicuously marked in advertisements requiring "three products and one device" shall be broadcast in audio advertisements.
(Refer to Article 10 of Order No. 21 of the Measures)
13. How to handle the approval of advertisements for drugs, medical devices, health foods, and formula foods for special medical purposes?
Online search for "State Administration for Market Regulation" - service - I want to check - click to download the latest version (add anti-counterfeiting code) enterprise end - download and fill in relevant information - export XML documents, advertising review form (PDF), advertising pictures (JPG) - print advertising review form and advertising pictures - prepare the corresponding materials to the Sichuan Provincial Administration for Market Regulation to handle relevant business.
14. How to inquire about the results of the approval of advertisements for drugs, medical devices, health foods, and formula foods for special medical purposes?
For advertisements for drugs, medical devices, health foods, and formula foods for special medical purposes that have been reviewed and approved, the advertising review organs shall disclose them to the public within 10 working days through the department's website and other methods that facilitate public inquiries. The information disclosed shall include content such as the advertising approval document number, the name of the applicant, the content of the advertisement release, the validity period of the advertisement approval document number, the advertisement category, the product name, the product registration certificate or the filing certificate number, and so forth.
Source: Food and Drug Law Garden, Pharmacy Headlines