(March 13, 2007 national food drug supervision authority, and national business administration General makes 27th, announced since May 1, 2007 up purposes) first article for strengthening drug advertising management, guarantee drug advertising of authenticity and legitimacy, according to People's Republic of China advertising method (following referred to advertising method), and People's Republic of China drug management method (following referred to drug management method) and People's Republic of China drug management method implementation Ordinance (following referred to
Drug Administration law implementing regulations) and national provisions relating to advertising, pharmaceutical supervision and management, these measures are formulated.
Article uses various media or publish advertisements contain the name of the drug, the drug indications (indications) or other content associated with the drug, drug advertising should be reviewed according to these measures.
OTC promotional drug name only (including the generic names of drugs and drug product), or on particular publications in medical pharmacy prescription drugs propaganda only drug names (including the generic names of drugs and drug product) without review.
Article III application for review of drug advertising, in line with the relevant provisions of the following laws and regulations, as well, may be passed in the examination: (a) the advertising Act, (ii) the drug management law and (iii) implementing regulations of the pharmaceutical administration law; (d) the standards for the examination and publication of drug advertisements and (v) other advertising-related regulations of the State. Fourth of provinces, autonomous regions and municipalities directly under the drug advertising review drug regulatory authorities, responsible for the administration of drug advertising in the review.
Industry and commerce administration departments at or above the county level is the supervision and administration of drug advertising agency.
Fifth the State food and Drug Administration on drug advertising review drug advertising review process guidance and supervision of drug advertising review Department acts in violation of these measures, be dealt with according to law. Sixth drug ad approval, applicants must have legal qualifications of a drug manufacturer or trading enterprises.
Pharmaceutical trading company as the applicant, you must obtain the drug manufacturer's consent.
Applicant may appoint agent agent drug ad approval number bid.
Article seventh application of drug ad approval number shall be made to the drug advertising review bodies, where the drug manufacturer.
Applications for import drug ad approval number shall be made to the imported drugs drug advertising review bodies, where the Agency. Eighth article application drug advertising approved paper,, should submitted drug advertising review table (Schedule 1), and attached and released content phase consistent of sample (sample, and sample with) and drug advertising application of electronic file, while submitted following real, and legal, and effective of proved file: (a) applicants of license copies; (ii) applicants of drug production license or drug business license copies; (three) applicants is drug business enterprise of,
Should submitted drug production enterprise agreed its as applicants of proved file original; (four) agent people on behalf of bid drug advertising approved paper, of, should submitted applicants of Attorney original and agent people of license copies, subject qualification proved file; (five) drug approved proved file (containing imports drug registered card, and medicine products registered card) copies, and approved of manual copies and actual using of label and the manual;
(Six) non-prescription drug advertising needed submitted non-prescription drug audit registration certificate copies or related proved file of copies; (seven) application imports drug advertising approved paper, of, should provides imports drug agent institutions of related qualification proved file of copies; (eight) advertising in the involved drug commodity name, and registered trademark, and patent, content of, should submitted related effective proved file of copies and other confirmed advertising content authenticity of proved file.
Copies of the supporting documents provided for in this article, need to stamp documents unit seal.
Nineth under any of the following circumstances, drug advertising review bodies not to accept applications for the enterprise the pharmaceutical advertising: (I) this article 20th, 22nd, 23rd articles will not be accepted; (b) revocation of approval of drug advertisements in its administrative procedures are being implemented.
Tenth Article drug advertising review organ received drug advertising approved paper, application Hou, on application material complete and meet statutory requirements of, to drug advertising accepted notice; application material not complete or not meet statutory requirements of, should spot or in 5 a days within once told applicants need correction of all content; late not told of, since received application material of day up that for accepted. Article 11th drug advertising review bodies shall within 10 working days from the date of acceptance, to prove the authenticity of the documents submitted by the applicant reviewed the validity, legality, and reviewed the content and advertising under the law.
The examination of drug advertisements, drug ad approval numbers; not qualified to review drug advertising shall not be issued to drug advertising approval number of the decision, notify the applicant in writing and state the reasons, at the same time inform the applicant have the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law. On approval of drug advertising, drug advertising review bodies shall report to the State food and Drug Administration for record, and will approve the drug advertising review form, to send advertising supervision and administration authorities for the record at the same level.
State food and Drug Administration for record-keeping problems in drug advertising, should be entrusted with drug advertising review bodies to remedy the situation.
On approval of drug advertising, pharmaceutical supervisory and administrative departments shall be announced to public.
12th in pharmaceutical production enterprises are located and imported drugs agencies located outside the province, autonomous region and municipality directly under the release of drug advertisements (hereinafter referred to as off-site releases drug ads), before being released to drug advertising review bodies for the record should be published.
13th remote publishing record of drug advertisements should submit the following materials: (a) copies of the drug advertising review form, and (ii) copies of approved medicines; (c) the television commercials and radio ads be submitted content consistent with the review of the tape, disc or other media support.
Provide copies of the material under this article, need to stamp documents unit seal.
14th in accordance with this article 12th, 13th provided off-site releases drug advertising application, drug advertising review bodies accepted within 5 working days after filing the application record should be given, in the endorsement on the drug advertising review form "filed", stamped with the Special seal for drug advertising review and send peer advertising regulatory authority for reference.
Record drug advertising review bodies think drug advertising does not comply with the provisions should fill out of the drug advertisements filed submissions (Schedule 2), the review bodies review the original examination and approval of drug advertising, and reported to the State food and drug administration. Drug advertising review of the original approval of advertisement for the record in the drug submissions should be received within 5 working days after, to drug advertising review bodies will inform the record.
Drug advertising review of the original approval authorities and record drug advertising review bodies cannot agree, can be brought to the State food and Drug Administration ruling.
15th drug ad approval number is valid for 1 year, and expire. 16th approved drug advertisement, publication shall not change the ad content.
Drug advertising content changes, and should re-apply for approval of drug advertisements.
Applicant self publish 17th ad drug advertising, originals of the drug advertising review form should be kept for 2 years for reference.
Advertisers, advertising agents advertising the applicant Agency, publishing, pharmaceutical advertising, originals shall be identification of the drug advertising review form, in accordance with the review and approval of the content, and save copies of the drug advertising review form for 2 years for reference. 18th an already approved drug ads in any of the following circumstances, drug advertising review of the original approval authority shall issue to the applicant a notice of the review of drug advertisements (Schedule 3), review.
During the review, the drug advertisements you may proceed to publish.
(A) believes that drug advertising review agencies of the State food and Drug Administration approval of medicines advertising does not comply with the provisions of (ii) to review recommendations of the advertising supervision and administration authorities at or above the provincial level, (iii) drug advertising review bodies deem a review of other cases.
Upon review, that does not comply with the statutory requirements of, withdrawing the drug advertising review form, original pharmaceutical advertising approval number invalid.
19th article has following case one of of, drug advertising review organ should cancellation drug advertising approved paper,: (a) drug production license, and drug business license was revoked of; (ii) drug approved proved file was revoked, and cancellation of; (three) national food drug supervision authority or province, and autonomous regions, and municipalities drug supervision management sector ordered stop production, and sales and using of drug.
Article 20th tampered with false propaganda on the content of the approved drug advertising, by the pharmaceutical supervisory and administrative departments shall be ordered to immediately stop the publication of drug advertisements, revoke the drug ad approval number, will not be accepted within 1 year of the vetting of advertising. Article 21st of any expanded indications (indications) range, absolute exaggerated drug effects, serious illegal ads that delude and mislead consumers, the provincial pharmaceutical supervisory and administrative departments at and above found, shall take administrative enforcement measures, suspended sales of the drugs in the area, and ordered to publish illegal drug advertisements in local press release correction.
Enterprises that illegally published drug advertising after you publish the correction as required, above the pharmaceutical supervisory and administrative departments shall, within 15 working days to make disarmament decisions of administrative compulsory measures; need for drug testing, the pharmaceutical supervisory and administrative departments shall, from the date of inspection reports issued in the 15th, and make a decision on whether to lift the compulsory administrative measures. 22nd to provide false information to apply for approval of drug advertisement, review bodies found in the admissibility of drug advertisements, will not be accepted within 1 year of the enterprise the vetting of advertising.
Article 23rd on the provision of false information to apply for approval of drug advertisements, made drug ad approval number, drug advertising review bodies should be withdrawn after it was discovered the drug ad approval number, and will not be accepted within 3 years the enterprise the vetting of advertising.
24th according to the article 18th, 19th, 20th and 23rd was withdrawn, cancellation or revocation of drug ad approval number of drug advertising, you must immediately stop publishing; remote censors stopped receiving the drug advertising corporate advertising of the drug ad approval number for the record.
Drug advertising review bodies in accordance with the present article 18th, 19th, 20th and 23rd, resumption, cancellation or revocation of approval of drug advertisements, shall make a decision of administrative handling within 5 working days of the date notice advertising regulatory bodies at the same level, supervisory and administrative organs shall be dealt with by advertising.
25th off-site releases drug advertising has not been released to drug advertising review authority for the record, drug advertising review bodies found after the release shall be ordered to go through formalities, it fails, stop advertising activity of the drug release. 26th pharmaceutical supervisory and administrative departments at and above the county level shall be examined and approved by the monitoring inspections of drug advertising.
On illegal released of drug advertising, levels drug supervision management sector should fill in illegal drug advertising transferred notice (Schedule 4), together with illegal drug advertising sample pieces, material, transferred sibling advertising supervision management organ investigation; belongs to offsite released tampered with by approved of drug advertising content of, released to drug advertising review organ also should to original approval of drug advertising review organ proposed in accordance with drug management method 92nd article, and this approach 20th article revoked drug advertising approved paper, of recommends.
27th on the release illegal drug advertisement, if the circumstances are serious, drug regulatory agency of provinces, autonomous regions and municipalities directly under the notice and report to the State food and drug administration, the State food and Drug Administration summary published on a regular basis.
False illegal drug advertisements serious and, if necessary, by the State administration for industry and commerce, in conjunction with the State food and Drug Administration jointly announce.
28th article on without review approved released of drug advertising, or released of drug advertising and review approved of content not consistent of, advertising supervision management organ should according to advertising method 43rd article provides be punishment; constitute false advertising or inductive misunderstanding of false publicity of, advertising supervision management organ according to advertising method 37th article, and anti-not due competition method 24th article provides be punishment.
Advertisement supervision and management bodies in dealing with the illegal medicine ads case, involving drug technical content need to be identified, shall inform of the need to identify the pharmaceutical supervisory and administrative departments at or above the provincial level, pharmaceutical supervisory and administrative departments at or above the provincial level shall, within 10 working days after receiving the notice of determination results advertising supervision and administration authorities. Article 29th drug advertising review staff and drug advertising supervision staff shall be subject to the advertising law, the drug management law and other relevant laws and regulations of the training. Drug advertising review and supervision of drug advertisement organs staff negligence, abuse of authority or engages in a disciplinary sanction.
Constitute a crime, criminal responsibility shall be investigated according to law. Article 30th drug ad approval number for "drug x wide (as) No. 0000000000", "drug x wide (acoustic) No. 0000000000," and "wide x drugs trial (article) No. 0000000000." Where "x" is referred to in various provinces, autonomous regions and municipalities directly under the. "0" for up to 10 digits, 6 representatives before the review date, 4 representatives of their approved serial numbers after.
"As", "", "" the classification of representative form for advertising media code. 31st article this way come into effect May 1, 2007.
March 22, 1995 issued by the Administration for industry and commerce, the Ministry of health of the drug advertising review (25th, SAIC) repealed simultaneously. Appendix 1: = (Editor's Note: fifth to sixth row following the end of the box symbols see manuscript) drug advertising review form drug names: generic name---------------(trade name)--------------ad categories: Visual-sound-the-drug classification: prescription drugs- Non-prescription drugs-the applicant--------------agent (seal)-------------review-----------------instructions 1, passed electronically fill out and print this form.
Print not clear, fill in incomplete inadmissible; 2, the "advertising content" section, sealed by the censors in the advertising content requirements edge Zhang Fang to be valid. 3, five copies of this form. Archiving a copy sent industrial and commercial administrative departments at one.
After examination and approval of advertising, after reviewing the authorities to agree to a corresponding increase in the number of copies. =tbl/>
=
┏━━━━━━━┯━━━━━━━━━━━━━━┯━━━━┯━━━━━━━━┓
┃ 申 请 人 │ │ 法 定 │ ┃
┃ │ │ 代表人 │ ┃
┠───────┼──────────────┴─ ───┴────────┨
┃ 地 址 │ ┃
┠───────┼──────────────┬────┬────────┨
┃ 邮政编码 │ │ 电 话 │ ┃
┠───────┼───────── ─────┼────┼────────┨
┃ E-mail │ │ 传 真 │ ┃
┣━━━━━━━┿━━━━━━━━━━━━━━┿━━━━┿━━━━━━━━┫
┃ 代 办 人 │ │ 法 定 │ ┃
┃ │ │ 代表人 │ ┃
┠───────┼──────────────┴────┴────────┨
┃ 地 址 │ ┃
┠───────┼──────────────┬────┬────────┨
┃ 邮政编码 │ │ 电 话 │ ┃
┠───────┼──────────────┼────┼────────┨
┃ E-mail │ │ 传 真 │ ┃
┠───────┼──────────────┼────┼─────── ─┨
┃ 具体经办人 │ │经 办 人│ ┃
┃ │ │联系电话│ ┃
┣━━━━━━━┿━━━━━━━━━━━━━━┷━━━━┷━━━━━━━━┫
┃ 药品通用名称 │ ┃
┠───────┼────────────────────────────┨
┃ 药品商品名称 │ ┃
┠───────┼────────────────────────────┨
┃ 生产批准文号 │ ┃
┠───────┼────────────┬───────┬───────┨
┃ 广告类别 │ │ 广告时长 │ 秒 ┃
┃（视、声、文）│ │ （视、声） │ ┃
┠───────┼ ────────────┴───────┴───────┨
┃ 计划发布媒介 │ ┃
┗━━━━━━━┷━━━━━━━━━━━━━━━━━━━━━━━━━━━━┛
=tbl/>
=
（编者注：下面表格的方框里的圆点见原稿）
┌──┬────┬───────────────────────────┐
│序号│ │ 证明文件目录（证明文件附后） │
├──┼────┼───────────────────────────┤
│ 1 │ □ │申请人营业执照 │
├──┼────┼───────────────────────────┤
│ 2 │ □ │药品生产许可证 │
├──┼────┼───────────────────────────┤
│ 3 │ □ │药品经营许可证 │
├──┼────┼───────────────────────────┤
│ 4 │ □ │药品注册批件 │
├──┼────┼───────────────────────────┤
│ 5 │ □ │批准的药品说明书 │
├──┼────┼───────────────────────────┤
│ 6 │ □ │实际使用的药品说明书 │
├──┼────┼───────────────────────────┤
│ 7 │ □ │实际使用的药品标签 │
├──┼────┼───────────────────────────┤
│ 8 │ □ │药品生产企业委托书（药 品经营企业作为申请人时） │
├──┼────┼───────────────────────────┤
│ 9 │ □ │进口药品注册证 │
├──┼────┼───────────────────────────┤
│ 10 │ □ │医药产品注册证
│
├──┼────┼───────────────────────────┤
│ 11 │ □ │药品商品名称批准文件 │
├──┼────┼───────────────────────────┤
│ 12 │ □ │非处方药品审核登记证书 │ ├──┼────┼───────────────────────────┤
│ 13 │ □ │商标注册证 │
├──┼────┼───────────────────────────┤
│ 14 │ □ │专利证明文件 │
├── ┼────┼───────────────────────────┤
│ 15 │ □ │法律法规规定的其他确认药品广告内容真实性的证明文件 │
├──┼────┼───────────────────────────┤
│ │ (1) │ │
├──┼────┼─────────── ────────────────┤
│ │ (2) │ │
├──┼────┼───────────────────────────┤
│ │ (3) │ │
├──┼────┼── ─────────────────────────┤
│ │ (4) │ │
├──┼────┼───────────────────────────┤
│ │ (5) │ │
├─ ─┼────┼───────────────────────────┤
│ │ (6) │ │
├──┴────┴───────────────────────────┤
│备注： │ │ 1, please submit proof of file box in front of "√"; │ │ 2, provide relevant supporting documents in the 15th, please fill in the documents under the name │ │ as is not enough, you can attach pages. │
└───────────────────────────────────┘
=tbl/>
=
┌───────────────────────────────────┐
│广告发布内容（样稿粘贴，样片、样带或者其他介质另附） │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
├───────────────────────────────────┤
│审查意见： │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ 审查机关签章： │
│ │
│ │
│ 日期： │
├────────┬──────────────────────────┤
│ 广告批准 文号 │ 药广审（ ）第 号 │
├────────┼──────────────────────────┤
│ 有效期至 │ 年 月 日 │
└────────┴──────────────────────────┘
=tbl/>
=
┌────── ─────────────────────────────┐
│异地广告审查机关备案意见 │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ 异地广告备案机关签章： │
│ │
│ 日期： 年 月 日 │
├──┬───────┬────────────────────────┤
│ │ 申 请 人 │ │
│ ├───────┼────────────────────────┤
│ │ 地 址 │ │
│ 备 │ （含邮编） │ │
│ 案 ├───────┼────────────────────────┤
│ 申 │ 联系电话 │ │
│ 请 ├───────┼──────── ────────────────┤
│ 人 │ 传 真 │ │
│ 情 ├───────┼────────────────────────┤
│ 况 │ E-mail │ │
│ ├───────┼
───────────┬───────┬────┤
│ │ 经 办 人 │ │ 经 办 人 │ │
│ │ │ │ 联系电话 │ │
└──┴───────┴───────────┴───────┴────┘
=tbl/>
附表2： =
药品广告备案意见书
（ ）第 号
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
______________食品药品监督管理局：
现发现，___药广审（ ）第_________
__ Record ad content has the following problems: now your Council.
(Here stamped record to review organ dedicated chapter) years day-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the notes: this instruments a type three copies, a copies archive reference, a copies sent approval to food drug supervision authority, a copies copy national food drug supervision authority. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
=tbl/>
附表3：
=
药品广告复审通知书
（ ）第 号
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
广告申请 人：______________________________________________________________
广告代办人：______________________________________________________________
药品名称：_____________________________ ___________________________________
药品广告批准文号：________________________________________________________
___________________________________________________________________ _______ (Following indicate review of reason) (here stamped review organ dedicated chapter) years day-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the notes: this instruments a type two copies, a copies archive reference, a copies make advertising applicants or advertising generation
Do people. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
=tbl/>
附表4：
=
违法药品广告移送通知书
（ ）药广移字（ ） 号
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
________工商 Administrative authority advertising supervision management sector: by verified, _____ years ___ months ___ day in (fill in media name, and period, and layout)-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the released of (fill in drug production Enterprise name)-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the-the of (fill in drug name) 广告，
────────── ────────────────────────
存在
────────────────────────────────────
违法问题。
According to law. 特此通知
XXXX食品药品监督管理局
（公 章）
年 月 日
───
------------------------------------Note: this instrument in triplicate, one copy for future reference, a copy, with the industrial and commercial administrative departments at the same level, a copy to the superior food and drug administration.
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
=tbl/>
