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    Home > Medical News > Latest Medical News > There is no need to provide the application electronic document to apply for the approval number of drug advertisement~

    There is no need to provide the application electronic document to apply for the approval number of drug advertisement~

    • Last Update: 2018-12-26
    • Source: Internet
    • Author: User
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    Recently, the General Administration of marketing issued the order No 4 of the State Administration of market supervision on the decision of the General Administration of market supervision on Amending the three regulations including the measures for the examination of drug advertisements, and decided to make the following modifications to the three regulations: the measures for the examination of drug advertisements, the measures for the examination of medical device advertisements and the measures for the assessment of measurement standards: 1、 Revision of measures for examination of drug advertisements (1) In the first paragraph of Article 8, "when applying for the approval number of drug advertisement, the examination form of drug advertisement (attached table 1) shall be submitted, and the sample manuscript (sample film, sample tape) and electronic documents of drug advertisement application consistent with the published content shall be attached Meanwhile, the following authentic, legal and effective supporting documents shall be submitted" shall be revised to "the approval number of drug advertisement, and the drug shall be submitted" Product advertisement review form (attached table 1), sample manuscript (sample film, sample tape) consistent with the published content, and the following authentic, legal and effective supporting documents " Delete the second paragraph (2) Article 14 shall be amended as "for the filing application for the release of drug advertisements in other places put forward in accordance with the provisions of articles 12 and 13 of these measures, the drug advertisement examination authority shall make a letter of commitment to inform, provide the applicant with a model text, and inform the filing conditions and required materials at one time." If the Applicant promises to meet the requirements and submits materials, it shall be filed on the spot " It is reported that Article 14 of the original measures for the examination of drug advertisements is "for the filing application for the publication of drug advertisements in other places put forward in accordance with the provisions of articles 12 and 13 of these measures, the drug advertisement examination authority shall make the filing within 5 working days after accepting the filing application, sign" filed "on the drug advertisement examination form, affix the special seal for the examination of drug advertisements, and send it to the same level The advertising supervision and administration organ shall keep it for future reference " (Note: the full text of the measures for the examination of drug advertisements (Order No 27 of the Bureau) is attached at the end of the paper 2 The measures for the examination of medical device advertisements are revised (1) In the first paragraph of Article 8, "when applying for the approval number of medical device advertisement, the examination form of medical device advertisement shall be filled in, and the sample manuscript (sample film, sample tape) and electronic document of medical device advertisement consistent with the published content shall be attached, and the following authentic, legal and effective supporting documents shall be submitted" shall be revised to "the approval number of medical device advertisement shall be submitted."《 Medical device advertisement review form, sample manuscript (sample film, sample tape) consistent with the published content, and the following authentic, legal and effective supporting documents " Delete the second paragraph (2) In the first paragraph of Article 11, "20 working days" shall be revised to "10 working days" 3、 To amend the measures for the assessment of measurement standards (1) to amend the first item of the first paragraph of Article 8 to "application for assessment (reexamination) of measurement standards and technical report of measurement standards" (2) The first paragraph of the first paragraph of Article 9 shall be amended as "application for assessment (reexamination) of measurement standards and technical report of measurement standards" This decision shall be implemented as of the date of promulgation Appendix: Measures for examination of drug advertisements (Order No 27 of the Bureau) Article 1 in order to strengthen the administration of drug advertisements and ensure the authenticity and legality of drug advertisements, in accordance with the advertising law of the people's Republic of China (hereinafter referred to as the "advertising law"), the drug administration law of the people's Republic of China (hereinafter referred to as the "Drug Administration Law") and the regulations for the implementation of the drug administration law of the people's Republic of China (hereinafter referred to as the "Regulations for the implementation of the drug administration law"), Article 1 )These measures are formulated in accordance with the provisions of the state on the supervision and administration of advertising and drugs Article 2 Where an advertisement published through various media or forms contains the name, indications (function indications) or other contents related to a drug, it is a drug advertisement and shall be examined in accordance with these measures There is no need for examination if over-the-counter drugs only publicize the name of the drug (including the general name and commodity name of the drug), or prescription drugs only publicize the name of the drug (including the general name and commodity name of the drug) in the designated professional journal of Medical Pharmacy Article 3 an application for examination of a drug advertisement may be approved only if it conforms to the following laws, regulations and relevant provisions: (1) advertising law; (2) drug administration law; (3) Regulations for the implementation of drug administration law; (4) standards for examination and publication of drug advertisement; (5) other provisions of the state on advertisement administration Article 4 the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government are the drug advertisement examination organs, which are responsible for the examination of drug advertisements within their respective administrative regions The administrative department for Industry and commerce at or above the county level is the supervisory and administrative organ for drug advertisements Article 5 the State Food and drug administration shall guide and supervise the drug advertisement examination work of the drug advertisement examination organ, and deal with the violation of these measures by the drug advertisement examination organ according to law Article 6 the applicant for the approval number of a drug advertisement must be a legally qualified drug production enterprise or drug handling enterprise Where a pharmaceutical trading enterprise is an applicant, it must obtain the consent of the pharmaceutical producing enterprise The applicant may entrust an agent to handle the application for approval number of drug advertisement Article 7 an application for the approval number of a drug advertisement shall be submitted to the drug advertisement examination organ in the place where the drug manufacturer is located An application for the approval number of an import drug advertisement shall be submitted to the drug advertisement examination organ in the place where the import drug agency is located Article 8 to apply for the approval number of drug advertisement, the examination form for drug advertisement (attached table 1) shall be submitted, together with the sample manuscript (sample film, sample tape) consistent with the published content and the electronic documents for drug advertisement application Meanwhile, the following authentic, legal and effective supporting documents shall be submitted: (1) the copy of the applicant's business license; (2) A copy of the applicant's pharmaceutical production license or pharmaceutical trading license; (3) if the applicant is a pharmaceutical trading enterprise, the original of the certification document that the pharmaceutical manufacturing enterprise agrees that it is the applicant; (4) Where the agent applies for the approval number of drug advertisement on behalf of the applicant, it shall submit the original of the power of attorney of the applicant, the copy of the business license of the agent and other main qualification certificates; (5) the copy of the drug approval certificate (including the registration certificate of imported drugs and the registration certificate of pharmaceutical products), the copy of the approved instructions, the labels and instructions for actual use; (6) For an over-the-counter drug advertisement, a copy of the over-the-counter drug examination and registration certificate or the relevant supporting documents shall be submitted; (7) for an application for the approval number of an import drug advertisement, a copy of the relevant qualification supporting documents of the import drug agency shall be provided; (8) If the advertisement involves the contents of drug commodity name, registered trademark, patent, etc., a copy of the relevant valid supporting documents and other supporting documents confirming the authenticity of the contents of the advertisement shall be submitted The photocopy of the supporting documents specified in this article shall be stamped with the seal of the certificate holder Article 9 under any of the following circumstances, the drug advertisement examination organ shall not accept the application of the drug advertisement of the enterprise: (1) under the circumstances of rejection as stipulated in Articles 20, 22 and 23 of these measures; (2) the administrative procedure of revoking the approval number of drug advertisement is in progress Article 10 after receiving the application for approval number of drug advertisement, the drug advertisement examination organ shall issue a notice of acceptance of drug advertisement to those whose application materials are complete and meet the legal requirements; if the application materials are incomplete or do not meet the legal requirements, it shall inform the applicant on the spot or within 5 working days of all the contents that need to be supplemented; if it fails to inform within the time limit, it shall receive the application materials from itself It shall be accepted from the date of acceptance Article 11 the drug advertisement examination organ shall, within 10 working days from the date of acceptance, examine the authenticity, legality and validity of the certification documents submitted by the applicant, and examine the contents of the advertisements according to law For qualified drug advertisements, the approval number of drug advertisements shall be issued; for unqualified drug advertisements, the approval number of drug advertisements shall not be issued, and the applicant shall be informed in writing with reasons, and the applicant shall be informed of the right to apply for administrative reconsideration or file administrative litigation according to law For the approved drug advertisements, the drug advertisement examination organ shall report to the State Food and Drug Administration for the record, and submit the approved drug advertisement examination form to the advertising supervision and administration organ at the same level for the record The State Food and drug administration shall instruct the drug advertisement examination organ to correct the drug advertisements with problems in the record keeping The pharmaceutical supervisory and administrative departments shall publish the approved pharmaceutical advertisements to the public in a timely manner Article 12 Where a drug advertisement is published in a province, autonomous region or municipality directly under the central government other than the place where the drug manufacturing enterprise is located or the place where the import drug agency is located (hereinafter referred to as "the advertisement of a drug published in a different place"), it shall be filed with the drug advertisement examination organ of the place where the advertisement is published Article 13 the following materials shall be submitted for the record of drug advertisement published in other places: (1) the copy of drug advertisement examination form; (2) the copy of approved drug instruction; (3) the audio tape, optical disk or other media carriers consistent with the reviewed contents shall be submitted for TV advertisement and radio advertisement Copies of the materials specified in this article shall be provided with the seal of the unit holding the certificate Article 14 the drug advertisement examination authority shall, within 5 working days after accepting the application for filing of the off-site publication of drug advertisement filed in accordance with the provisions of articles 12 and 13 of these measures, record it, sign "filed" on the drug advertisement examination form, affix the special seal for drug advertisement examination, and submit it to the advertising supervision and administration authority at the same level for reference Where the drug advertisement examination authority at the place where the record is filed considers that the drug advertisement does not conform to the relevant provisions, it shall fill in the opinion on drug advertisement record (attached table 2), submit it to the original examination and approval drug advertisement examination authority for review, and copy it to the state food and drug administration The original examination and approval organ of drug advertisement shall, within 5 working days after receiving the opinions on filing of drug advertisement, inform the examination and approval organ of drug advertisement at the place of filing of the opinions If the opinions of the original approved drug advertisement examination organ and the drug advertisement examination organ at the place where the record is filed cannot be reached, they may be submitted to the State Food and Drug Administration for a ruling Article 15 the period of validity of the approval number of drug advertisement is one year, which is invalid upon expiration Article 16 approved drug advertisements shall not be changed when they are published If the contents of a drug advertisement need to be changed, the approval number of the drug advertisement shall be reapplied Article 17 Where an advertisement applicant publishes a drug advertisement on his own, he shall keep the original of the drug advertisement examination form for two years for future reference Where an advertisement publisher or advertising agent is entrusted by an advertisement applicant to act as an agent or issue a drug advertisement, it shall check the original copy of the drug advertisement examination form, publish it in accordance with the contents approved by the examination, and keep the copy of the drug advertisement examination form for two years for future reference Article 18 in case of any of the following circumstances in the approved drug advertisement, the original examination and approval organ of drug advertisement shall issue the notice of reexamination of drug advertisement (attached table 3) to the applicant for reexamination During the period of reexamination, the advertisement of the drug may continue to be published (1) In the opinion of the State Food and Drug Administration
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