(Released November 24, 2004, the Ministry of agriculture to 44th come into force on January 1, 2005) Chapter I General provisions article to ensure that veterinary drug safe, effective and quality controlled, standardized registration of veterinary drugs, in accordance with the regulations on the management of veterinary drugs, these measures are formulated.
Article in the People's Republic of China territory of new veterinary drug registrations and registration of veterinary drugs imported, should comply with these measures.
Article III Ministry of agriculture is responsible for the national registration of veterinary drugs.
Department of agriculture veterinary drug evaluation Committee is responsible for new veterinary drugs and importing veterinary drug registration review work.
China Institute of veterinary drug control and other veterinary drug inspection institutions designated by the Ministry of agriculture veterinary drug registration verification work.
Chapter IV of new veterinary drugs registered new veterinary drug registration applicant shall after the completion of clinical trials, to apply to the Ministry of agriculture, and information submitted in accordance with the data requirements for registration of veterinary drugs.
Fifth joint development of new veterinary drugs can be combined by one of the units to apply for registration or application for registration, shall not be applied for registration; joint applications for registration shall be jointly signed by the applicants of the new veterinary drugs. Information submitted by the sixth application for new registration of veterinary drugs should be complete, standard, data must be truthful and reliable.
Reference documents should indicate the name, publication name, volume, issue, page, etc; unpublished documentation should provide information owner permission to use documents shall be in accordance with the requirements of foreign language materials to produce a Chinese translation.
When applying for a new veterinary drug registration, the applicant shall submit a letter of guarantee, commitment does not constitute an infringement of intellectual property rights of others and is responsible for the consequences of possible infringement, ensuring the authenticity of data obtained on their own.
Information outside the veterinary test and research data, shall be attached to foreign research institutions, information projects, page description, and the Agency's legal registration documents notarized.
Seventh article has following case one of of new veterinary drugs registered application, not accepted: (a) Ministry of agriculture has announcement in monitoring period, applicants cannot proved data for himself made of veterinary drugs; (ii) by gene engineering technology get, not through biological security evaluation of out live vaccine, and diagnosis products zhiwai of veterinary drugs; (three) application material not meet requirements, in provides during within not correction of; (four) not accepted of other case.
Eighth Ministry within 10 working days from the date of receipt of the application, decided to accept applications for registration of new veterinary drugs information Department of agriculture veterinary drug evaluation Commission in assessing the technical and notifies the applicant is required to submit verification of 3 consecutive batch of samples and related information, send designated veterinary drug inspection agency for verification.
Apply for new veterinary drugs belonging to biological products and, if necessary, about the kinds of HIV tests.
The Nineth Department of agriculture veterinary drug evaluation Committee shall be made within 120 days from the date of receipt of the information review comments, and submitted to the Ministry of agriculture.
Review the need to supplement the information contained in, the applicant should be completed within 6 months from the date of receipt of the notification data; if correction is not deemed automatic withdrawal of the application for registration.
Article tenth of veterinary drug inspection agency should complete verification within a specified time, and inspection reports and review comments on the applicant and submitted to the Ministry of agriculture and the Ministry of agriculture veterinary drug evaluation Committee.
Initial samples failed to pass the test, the applicant can sample verification again. 11th Ministry of agriculture received a technical review and verification completed within 60 working days of the conclusion of the review, if necessary, can the costs of on-site verification. Examination, issue a new certificate of registration of veterinary drugs, and announce and publish the new veterinary drug standards, labels and instructions.
Not qualified, notify the applicant in writing.
During the 12th new veterinary drug registration and approval, technical requirements for new veterinary drugs due to changes in the same varieties in overseas listing, according to the technical requirements for approval.
Chapter III import veterinary drugs registered the 13th export veterinary medicine in China for the first time, should the exporter's territory to China's offices or by its authorized agents in China to apply to the Ministry of agriculture, fill in the application form for the registration of veterinary drugs, and information submitted in accordance with the data requirements for registration of veterinary drugs.
Veterinary Biologics applications for exports to China, should also provide bacteria (virus, insect) species, cells and other relevant materials and information. Article 14th veterinary drug preparation registration must be provided for the preparation of raw materials and production materials, direct contact with veterinary proof of legitimate sources of the packaging materials and containers.
API has not yet been approved by the Ministry of Agriculture made, shall also apply for drug registration, and shall be submitted to the relevant production processes, quality index and test method of research data. Information submitted by the 15th for import registration of veterinary drugs should be complete, standard, data must be truthful and reliable.
Reference documents should indicate the name, publication name, volume, issue, page, etc; foreign materials should be in accordance with the requirement to produce a Chinese translation.
16th Department of agriculture within 10 working days from the date of receipt of the application organized a preliminary examination, upon preliminary examination, is admissible, and notify the applicant in writing.
To be admissible, the Ministry of agriculture will import veterinary drug registration applications sent the Ministry of agriculture veterinary drug evaluation committee assessing the technical, and notify the applicant is required to submit verification of 3 consecutive batch of samples and related information, send designated veterinary drug inspection agency for verification. 17th article has following case one of of imports veterinary drugs registered application, not accepted: (a) Ministry of agriculture has announcement in monitoring period, applicants cannot proved data for himself made of veterinary drugs; (ii) by gene engineering technology get, not through biological security evaluation of out live vaccine, and diagnosis products zhiwai of veterinary drugs; (three) China provides of a blight and domestic not occurred blight of live vaccine; (four) from area may caused blight in China territory spread of beast with biological products; (five) application information not meet requirements,
Correction is not made within the specified period (vi) other circumstances as inadmissible.
The 18th article import registration of veterinary drugs evaluation and inspection procedures for the Nineth and tenth provisions of these measures.
19th veterinary chemicals registered for import should be in the People's Republic of China territory designated agencies for clinical trials and residue testing methods to verify, if necessary, the Ministry of agriculture residue trials may require to determine the withdrawal period.
Belongs to the application for registration of veterinary drugs and biological products, the Agriculture Department could ask for in a People's Republic of China territory designated agencies for safety and efficacy testing. 20th Department of agriculture receives technology review and verification completed within 60 working days of the conclusion of the review, if necessary, can the costs of on-site verification. Examination, of importing veterinary drug registration certificate will be issued, and announce them; China's Hong Kong, Macao and Taiwan manufacturers in the area of applications for registration of veterinary drugs, veterinary drug registration certificate will be issued.
Failed to pass the examination, notify the applicant in writing.
Ministry of agriculture import permit registration of veterinary drugs at the same time, publish approved standards of importing veterinary drug and product labels and instructions.
21st Ministry of agriculture to apply for import risk analysis of veterinary drugs, risk analysis is a security risk and is not registered.
Fourth chapter of veterinary drugs veterinary drugs registered change of registered the 22nd's proposed change to the original matter, shall apply to the Department of agriculture veterinary drug registration changes. The 23rd when the applicant applies for registration changes, should fill out the application form for veterinary drug registration changes, submit the relevant materials and instructions.
Related to veterinary drug product ownership change, should provide valid identification documents.
Imported veterinary drugs changes to registration, the applicant shall also submit the manufacturer country (region) of veterinary regulatory agencies approve the change file. 24th decision accepted by the Ministry of Agriculture's veterinary drug registration changes without the need for technical review of an application within 30 working days from the date of receipt of an application, complete the review.
Examination, approve the change register.
Technical review of the need for change applications for registration of veterinary drugs, the Ministry of agriculture will accept materials Department of agriculture veterinary drug evaluation Committee and notifies the applicant is required to submit verification of 3 consecutive batch of samples and related information, send designated veterinary drug inspection agency for verification.
25th article change the review of applications for registration of veterinary drugs, testing procedures, the time limit and requirements to apply this approach to the new veterinary drug registration requirements registration of veterinary drugs and import.
Requests for changes in standards of veterinary drug registration changes, veterinary drug inspection bodies shall be for standard review. Article 26th Ministry of agriculture received a technical review and verification completed within 30 working days from the date of the conclusion of the review, examination, approve the change register.
Failed to pass the review, inform the applicant in writing. Fifth chapter import certificate of re-registration of veterinary drugs 27th article import registration of veterinary drugs and the veterinary drug registration certificate is valid for 5 years.
Need to continue importing the expiry, the applicant shall, before the expiry of 6 months apply for registration to the Ministry of agriculture.
28th when they apply for re-registration of veterinary drugs imported under article should fill out the application form for the re-registration of veterinary drugs, and information submitted in accordance with the data requirements for registration of veterinary drugs. 29th after the Ministry of agriculture in accepting an application for re-registration of veterinary drugs imported, shall, within 20 working days to complete the review. Eligible be registered again.
Does not meet the requirements, notify the applicant in writing.
30th article has following case one of of, not again registered: (a) not in validity expires 6 months Qian proposed again registered application of; (ii) not by provides submitted veterinary drugs bad reaction monitoring report of; (three) by Ministry of agriculture security again evaluation was as ban using varieties of; (four) by test production conditions not meet provides of; (five) by risk analysis exists security risk of; (six) China provides of a blight and domestic not occurred blight of live vaccine;
(G) from the affected area may result in spread of epidemics in China biological products for animal uses; (h) according to law shall not be re-registered.
31st shall not be re-registered by the Ministry of agriculture cancelled the importing veterinary drug registration certificate or in the certificate of registration of veterinary drugs, and make an announcement.
Sixth chapter verification section 32nd for the registration of veterinary drugs veterinary drugs veterinary drugs should be carried out verification, including sample inspection and veterinary medicine quality standard of review.
Article 33rd verification testing of veterinary drugs veterinary drugs agencies, shall conform to the Veterinary examination practices.
34th the applicant should provide the veterinary inspection agency veterinary drugs required for verification-related information and samples, providing reference material for inspection and necessary materials. Required for the registration of veterinary drugs 3 samples, shall be made in the workshop production of the veterinary drug GMP certificate.
Each batch of samples shall be for the purpose of sale of 3 minimum packaging and test 3~5 times the amount.
35th veterinary drug inspection institutions to conduct veterinary medicine quality standard of review, except for sample surveys, should also be in accordance with the veterinary research, veterinary medicine quality standard of similar products at home and abroad and relevant State requirements for the veterinary drugs veterinary drugs quality standards, inspection items and methods, such as review comments.
Article 36th veterinary drug inspection agency after receiving the test notification and sample, should be completed within 90 working days sample inspection, issue an inspection report requires special methods of veterinary drugs should be completed within 120 days.
Sample inspection and veterinary medicine quality standard of review is required, and veterinary drug inspection bodies shall be completed within 120 working days; requires special methods of veterinary drugs should be completed within 150 days.
Seventh chapter of veterinary drugs standard management of the 37th China Institute of veterinary drug control is responsible for calibrating and supply the national standards for veterinary drugs.
China Institute of veterinary drug control organizations related provinces, autonomous regions and municipalities directly under the veterinary, veterinary medicine research or veterinary drug manufacturers calibration national standards for veterinary drugs.
38th applicants in applying for a new registration of veterinary drugs and importing veterinary drug registration, preparation of the China Institute of veterinary drug control should be provided veterinary standards of raw materials, and to submit the relevant reference material of research data.
39th article China veterinary drug monitored by on veterinary drugs standard material of raw materials select, and preparation method, and calibration method, and calibration results, and set value accuracy, and volume value tracing, and stability and the points loaded and packaging conditions, information for full technology audit; necessary Shi, for calibration or organization for calibration, and made will as national veterinary drugs quality standard material of recommended conclusion, reported national veterinary drugs Code Committee review.
40th Ministry of Agriculture approved under national veterinary Pharmacopoeia Committee reviews national quality standards for veterinary drugs and veterinary drug standards published the list of substances and quality standards.
Eighth chapter penalty 41st applicant provides false information, samples or other fraudulent means to apply for registration, the Agriculture Department not to grant the application, warning to the applicant, the applicant may not apply again for the registration of veterinary drugs within a year.
The applicant provides false information, samples or take other dishonest means to achieve veterinary drug registration documents, according to the provisions of the regulations on the management of veterinary medicines 57th penalty, the applicant may not apply again for the registration of veterinary drugs within three years.
42nd other acts in violation of these rules, in accordance with the relevant provisions of the regulations on the management of veterinary drugs for punishment.
Nineth chapter supplementary articles article 43rd spirit of veterinary drugs, veterinary drugs, veterinary medical toxic drugs, radioactive drugs and import of new veterinary drugs veterinary drugs registration, except in accordance with these rules shall apply, but should also comply with the other relevant regulations of the State.
44th article according to the needs of animal epidemic prevention, Department of agriculture national veterinary reference laboratories recommended compulsory immunization vaccine production using bacterial (viral) kinds of changes implemented for the record business, you don't want to change.
45th these measures come into force on January 1, 2005.
