Administrative Measures On Veterinary Drug Approval Number

Original Language Title: 兽药产品批准文号管理办法

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  Chapter I General provisions article to strengthen the management of veterinary drug product approval number, in accordance with the regulations on the management of veterinary drugs, these measures are formulated.

Article animal drug product approval number the application, issuance and regulatory procedures apply.

The third production of veterinary drugs veterinary drugs, veterinary drug product approval number issued by the Ministry of agriculture should be made.

Veterinary drug product approval number is national standards, according to the Ministry of agriculture veterinary drugs in the production process and production conditions of approval of specific veterinary drug manufacturers produce specific veterinary drug approval document issued by the veterinary drug products.

The fourth Ministry of agriculture is responsible for the national veterinary drug product approval number issued by the work management and supervision.

Veterinary Administrative Department under the people's Governments at and above the county level shall be responsible for the administrative supervision of veterinary drug product approval number.

Chapter II veterinary drug product approval number the application and issuance of the fifth application for product approval number of veterinary drugs veterinary drugs should be subject to the following conditions: (a) in the veterinary drug production licenses containing the production range; (b) was not revoked within three years prior to the application the approval numbers of the product record.

Applications for veterinary drug product approval number 2 times in a row to review test results do not meet requirements, within 1 year not to proceed with the application for veterinary drug product approval number. Sixth article application this enterprise development of has get new veterinary drugs registered certificate of veterinary drugs products approved paper,, and new veterinary drugs registered Shi of review samples Department applicants production of, applicants should to Ministry of agriculture submitted following information: (a) veterinary drugs products approved paper, application table a type a copies; (ii) veterinary drugs production license copies a type a copies; (three) veterinary drugs GMP certificate copies a type a copies; (four) new veterinary drugs registered certificate copies a type a copies; (five) review test report copies a type a copies

(Vi) labels and samples in duplicate; (VII) product, production, a copies of the recipes and other information. Department of agriculture within 5 working days from the date of receipt will be sent for information specialists in the China Institute of veterinary drug control, and on the date of receipt of the review comments within 15 working days from approval decisions.

In conformity with the provisions and issuance of veterinary drug product approval number, approval of labels and instructions; do not meet requirements, notify the applicant in writing and state the reasons.

Applications developed by the enterprise has received the new certificate of registration of veterinary drugs veterinary drugs the approval number, but when a new veterinary drug registration review samples of non-production of the applicant, respectively, in accordance with the present article seventh and Nineth regulations, applicants do not need to submit copies of intellectual property transfer contracts or power of attorney. Seventh article application others transfer of has get new veterinary drugs registered certificate or imports veterinary drugs registered certificate of biological products class veterinary drugs products approved paper, of, applicants should to Ministry of agriculture submitted this enterprise production of continuous three a batch of samples and following information: (a) veterinary drugs products approved paper, application table a type a copies; (ii) veterinary drugs production license copies a type a copies; (three) veterinary drugs GMP certificate copies a type a copies; (four) new veterinary drugs registered certificate or imports veterinary drugs registered certificate

Copies a type a copies; (five) label and manual sample a type II copies; (six) by submitted samples of since check report a type a copies; (seven) products of production process, and formula, information a type a copies; (eight) intellectual property transfer contract or authorized book a type a copies (first application provides original, renewal application provides copies and stamped applicants seal).

Samples should be submitted by the provincial veterinary drug Inspection Agency site, and add to stick the seal. The Ministry of agriculture within 5 working days from the receipt of samples and application materials sent China Institute of veterinary drug control required for verification and expert review, and receipt of inspection findings and review comments made within 15 working days from the date of the approval decision.

In conformity with the provisions and issuance of veterinary drug product approval number, approval of labels and instructions; do not meet requirements, notify the applicant in writing and state the reasons.

Eighth article application sixth article, and seventh article provides zhiwai of biological products class veterinary drugs products approved paper, of, applicants should to Ministry of agriculture submitted this enterprise production of continuous three a batch of samples and following information: (a) veterinary drugs products approved paper, application table a type a copies; (ii) veterinary drugs production license copies a type a copies; (three) veterinary drugs GMP certificate copies a type a copies; (four) label and manual sample a type II copies; (five) by submitted samples of since check report a type a copies;

(Vi) product, production, a copies of the recipes and other information; (VII) bacterial (viral, insect) legal source copy (stamped with the official seal of the applicant).

Samples should be submitted by the provincial veterinary drug Inspection Agency site, and add to stick the seal. The Ministry of agriculture within 5 working days from the receipt of samples and application materials sent China Institute of veterinary drug control required for verification and expert review, and receipt of inspection findings and review comments made within 15 working days from the date of the approval decision.

In conformity with the provisions and issuance of veterinary drug product approval number, approval of labels and instructions; do not meet requirements, notify the applicant in writing and state the reasons. Nineth article application others transfer of has get new veterinary drugs registered certificate or imports veterinary drugs registered certificate of non-biological products class of veterinary drugs products approved paper, of, applicants should to location provincial government veterinary administration sector submitted this enterprise production of continuous three a batch of samples and following information: (a) veterinary drugs products approved paper, application table a type II copies; (ii) veterinary drugs production license copies a type II copies; (three) veterinary drugs GMP certificate copies a type II copies; (four)

New veterinary drugs registered certificate or imports veterinary drugs registered certificate copies a type II copies; (five) label and manual sample a type II copies; (six) by submitted samples of batch production, and batch test original copies and the since check report a type II copies; (seven) products of production process, and formula, information a type II copies; (eight) intellectual property transfer contract or authorized book a type II copies (first application provides original, renewal application provides copies and stamped applicants seal).

Provincial Veterinary Administration received information and samples within 5 working days from the date the samples sent veterinary drug inspection institutions at the provincial level for verification, and receipt of the verification completed within 10 working days from the date of the conclusion of a preliminary review, will review the comments and review inspection reports and a copies of all application materials submitted to the Ministry of agriculture. Department of agriculture veterinary Administrative Department under the people's Governments at the provincial level to review comments received within 5 working days from the date sent by the China Institute of veterinary drug control for expert review, and receipt of the review comments made within 10 working days from the date of the approval decision.

In conformity with the provisions and issuance of veterinary drug product approval number, approval of labels and instructions; do not meet requirements, notify the applicant in writing and state the reasons.

Section tenth for the sixth, Nineth provides veterinary drug product approval number other than non-biological products, the Ministry of agriculture the progressive introduction of test management. Implementation of test management of veterinary drugs list of requirements and the test formulated by the Ministry of agriculture.

Inspection Agency carried out test shall comply with non-clinical research and the quality control of veterinary drugs standard and veterinary medicine clinical test specification, the list published by the Ministry of agriculture. 11th article tenth article provides of veterinary drugs yet included than on test varieties directory of, applicants should to location provincial government veterinary administration sector submitted following information: (a) veterinary drugs products approved paper, application table a type II copies; (ii) veterinary drugs production license copies a type II copies; (three) veterinary drugs GMP certificate copies a type II copies; (four) label and manual sample a type II copies; (five) products of production process, and formula, information a type II copies; (six) site verification application single

A duplicate. Veterinary Administrative Department under the people's Governments at the provincial level shall, within 5 working days from the date of receipt of the information organization to review the application materials.

In conformity with the provisions, should be with the applicant agreed field verification time, organized on-site verification verification requirements, take three samples on the spot, plus closure sign and sent veterinary drug inspection institutions at the provincial level for verification.

Veterinary Administrative Department under the people's Governments at the provincial level since the review, on-site verification or verification within 10 working days from the date of completion of this review, review inspection reports and a copies of all application materials submitted to the Ministry of agriculture. Department of agriculture veterinary Administrative Department under the people's Governments at the provincial level to review comments received within 5 working days from the date, applications will be sent by the China Institute of veterinary drug control experts, review the comments received and made within 10 working days from the date of the approval decision.

  In conformity with the provisions and issuance of veterinary drug product approval number, approval of labels and instructions; do not meet requirements, notify the applicant in writing and state the reasons.

12th article tenth of the species has been included in the test directory of veterinary drugs, submitted in accordance with article 11th application, on-site verification, sampling and verification, but taking on three batches of samples should have a number of online sample. Veterinary Administrative Department under the people's Governments at the provincial level since receiving the verification completed within 10 working days from the date of the conclusion of a preliminary review. Through a preliminary review, notify the applicant pharmaceutical research related information and add seal online samples to its autonomous institutions selected test.

Comparative test bodies should be strictly in accordance with the drug than to test the guiding principles of conduct test, report distribution and test veterinary Administrative Department under the people's Governments at the provincial level and the applicant.

Veterinary Administrative Department under the people's Governments at the provincial level will be on-site verification reports, verification reports, test plan, test protocols, specific pharmaceutical research of test reports, related information and one copy of all application information reported to the Ministry of agriculture. Department of agriculture information on the receipt of the application within 5 working days from the date sent by the China Institute of veterinary drug control for expert review, and receipt of the review comments made within 10 working days from the date of the approval decision.

In conformity with the provisions and issuance of veterinary drug product approval number, approval of labels and instructions; do not meet requirements, notify the applicant in writing and state the reasons.

13th data review, on-site verification, verification does not meet the requirements or test, veterinary administrative departments under the people's Governments at the provincial level the applicant wishes to be returned to the applicant for information.

Article 14th test varieties before the list was released have been given management of veterinary drugs veterinary drugs veterinary drug product approval number, shall, within the prescribed period in accordance with article 12th supplement test and provide relevant materials, not adopted within the prescribed period to review, in accordance with the regulations on the management of veterinary drugs article 69th second to lift the product approval number. 15th issued by the Department of agriculture in new veterinary drugs veterinary drugs when product approval number may be set up not more than 5-year monitoring period.

During the monitoring period, the new animal drug is not approved for production or import.

Production enterprises should be collected during the monitoring period the new veterinary drug efficacy and adverse reaction data, and submitted to the Ministry of agriculture.

After expiry of the monitoring of veterinary drugs and other veterinary drug manufacturers under this approach the seventh to Nineth or the provisions of article 12 apply for veterinary drug product approval number, but should be submitted and signed a contract of assignment or licensing of intellectual property, or statement does not constitute an infringement of the patent rights of others.

16th under any of the following circumstances, veterinary medicine production enterprises shall, in accordance with the article eighth or article 11th reapply for veterinary drug product approval number, veterinary drug products comparative tests were carried out and the results are in line with provisions of the no longer test: (a) relocation of reconstruction, (ii) new offsite workshop, (iii) other circumstances that changed production site.

17th veterinary drug product approval number needs to continue production of the expiry, veterinary drug manufacturers shall, before the expiry of 6 months according to the approved procedures apply for veterinary drug product approval number of the replacement.

In veterinary drug product approval number within the validity period, class 1 batch of biological products or non-biological products 3 batches of supervision by the people's Governments above provincial level administrative departments above sampling and all that pass the veterinary drug product approval number change without verification.

Comparative tests were carried out and the results are in conformity with the provisions of veterinary products, veterinary drug product approval number change will no longer be on the test.

18th there is evidence that there are security risks of veterinary drug products, veterinary drug product approval number the Ministry suspended the application has been accepted, suspension of the veterinary drug product approval number issued.

Article 19th major animal disease prevention and control in China urgently needed veterinary drug products and, if necessary, temporary veterinary approval number issued by the Ministry of agriculture.

Temporary veterinary approval number valid for not more than 2 years. 20th veterinary drug inspection bodies shall be completed within 90 days from the date of receipt of the samples tested, the samples should be under observation.

Samples belonging to biological products, inspection period shall not exceed 120 working days.

China Institute of veterinary drug control expert assessment shall not exceed the time limit of 30 working days; implement test, experts review the time limit may not exceed 90 working days.

Chapter III veterinary drugs on-site verification and sampling 21st provincial veterinary administrative departments responsible for on-site verification and sampling should be based on the need to set up on-site verification sampling group of 2-4 people.

22nd field verification of on-site sampling sampling personnel, shall, in accordance with veterinary medicine sampling regulations, ensure the scientific and impartial nature of sampling. Samples should be tested and test programme set forth the 3-5 times the number of extraction, and a separate seal.

Of the veterinary check by sampling personnel and was signed by sampling units and special seal and shall affix unit veterinary drugs test samples sample unit.

23rd article site verification should including following content: (a) management system developed and implementation situation; (ii) development, and production, and test personnel related situation; (three) raw materials purchased into and using situation; (four) development, and production, and test equipment and instrument status whether meet requirements; (five) development, and production, and test conditions whether meet about requirements; (six) related production, and test records; (seven) other need site verification of content.

On-site inspectors to the development, production, and inspection sites, equipment, instruments, raw materials, intermediates and finished products, researching records, photograph or copy, as the on-site verification annex to the report.

Supervision and administration of the fourth chapter 24th veterinary Administrative Department under the people's Governments at and above the county level should be on-site examinations on the area of veterinary drug manufacturers. Site check in the, found veterinary drugs production enterprise has following case one of of, by County above place Government veterinary administration sector law made processing decided, should revoked, and revoked, and cancellation veterinary drugs products approved paper, or veterinary drugs production license of, timely reported sent card organ processing: (a) production conditions occurred major changes of; (ii) no according to veterinary drugs production quality management specification of requirements Organization production of; (three) products quality exists hidden of; (four) other violation veterinary drugs Management Ordinance

And these rules.

25th veterinary Administrative Department under the people's Governments at and above the county level should be listed veterinary products supervision and inspection, found to be in violation of this regulation, make a decision according to law, shall withdraw approval, revocation, cancellation of veterinary drug products, or veterinary drug production licenses, certification authority in a timely manner.

Article 26th veterinary drug product approval number sold, leased, lent, penalty shall be imposed in accordance with article 58th of the veterinary medicines regulations.

27th article has following case one of of, by Ministry of agriculture cancellation veterinary drugs products approved paper,, and be announcement: (a) veterinary drugs production license validity expires not application continued or application Hou not get approved of; (ii) veterinary drugs production enterprise stop production over 6 months or close of; (three) issued veterinary drugs products approved paper, by according to of veterinary drugs national quality standard was abolition of; (four) should cancellation of other case. 28th article production of veterinary drugs has following case one of of, according to veterinary drugs Management Ordinance 69th article first paragraph second items of provides revoked veterinary drugs products approved paper,: (a) change group party added other components of; (ii) except biological products and not provides ceiling of medicine class products outside, main components content in veterinary drugs national standards 150% above, or main components content in veterinary drugs national standards 120% above and cumulative 2 batch of; (three) main components content in veterinary drugs national standards 50% following,

Or contents of main components in national standards for veterinary drugs 80% today and 2 batches over and (iv) other efficacy, adverse reactions, and possible uncertainty of farming, human health risk, or potential risk situations.

29th the applicant concealed relevant information or provide false materials, sample applications for veterinary drug product approval number, inadmissible or not be issued to the Ministry of agriculture veterinary drug product approval number applicant allowed to re-apply within 1 year of the veterinary drug product approval number.

30th the applicant provides false information, samples or other approval from the veterinary drug product deception number, according to the provisions of the regulations on the management of veterinary medicines 57th penalties applicants allowed to re-apply in 3 years the veterinary drug product approval number. 31st veterinary drug intellectual property disputes by the parties in accordance with the relevant intellectual property rights laws and regulations.

Intellectual property management department or court judgement found infringement is established, legally cancellation has been issued by the Department of Agriculture's veterinary drug product approval number.

Fifth chapter supplementary articles article 32nd veterinary drug approval numbers of the product categories referred to as + enterprise presentation for veterinary drugs is located (autonomous regions and municipalities) serial number + Enterprise serial number + number of veterinary drugs. Format is as follows: (a) the veterinary category abbreviations.

Drug feed additives of category referred to for "veterinary drugs added word"; serum products, and vaccine, and diagnosis products, and micro-ecological products, category referred to for "veterinary drugs words"; Chinese herbal medicines, and proprietary Chinese medicines, and chemical drug, and antibiotics, and biochemical drug, and radioactive drug, and topical pesticides and disinfectant, category referred to for "veterinary drugs word"; raw materials drug referred to for "veterinary drugs original word"; Ministry of agriculture issued of temporary veterinary drugs products approved paper, referred to for "veterinary drugs Pro word".

(B) the local provinces (autonomous regions and municipalities) serial number with 2 digits, prescribed by the Ministry of agriculture and announced.

(C) Enterprise serial numbers sorted by province, represented by a 3-digits, issued by the veterinary Administrative Department under the people's Governments at the provincial level.

(D) the varieties number with 4 digits for veterinary drugs, prescribed by the Ministry of agriculture and announced. 33rd article this way come into force May 1, 2016, November 24, 2004, the Ministry of Agriculture published by the management of veterinary drug product approval number (Ministry of agriculture, the 45th) repealed simultaneously.

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