Measures for the Registration of Veterinary Drugs
Measures for the Registration of Veterinary Drugs
Measures for the Registration of Veterinary Drugs
Order of the Ministry of Agriculture [2004] No. 44
November 24, 2004
Minister Du Qinglin
Attached: Measures for the Registration of Veterinary Drugs
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Regulations on the Administration of Veterinary Drugs for purposes of ensuring the safety, effectiveness and quality control of veterinary drugs and regulating the acts of veterinary drug registration.
Article 2 These Measures shall apply to the registration of new veterinary drugs and registration of imported drugs within the territory of the People's Republic of China.
Article 3 The Ministry of Agriculture shall be responsible for the work of veterinary drug registration.
The Veterinary Drug Appraisal Committee under the Ministry of Agriculture shall be responsible for the appraisal of the registration materials of new veterinary drugs and imported veterinary drugs.
The China Institute of Veterinary Drug Control and other veterinary drug inspection institutions as designated by the Ministry of Agriculture shall undertake the work of checking and inspecting the registration of veterinary drugs.
Chapter II Registration of New Veterinary Drugs
Article 4 An applicant for the registration of any new veterinary drug shall, after completing clinical tests, file an application to the Ministry of Agriculture, and submit relevant materials in accordance with the Requirements on the Registration Materials of Veterinary Drugs.
Article 5 In the case of any new veterinary drug jointly developed by two or more entities, the registration may be applied for by any of the entities or applied for jointly by the entities, but no repetitive registration is allowed. Where the entities apply jointly for registration, they shall sign their names together as the applicants of the new veterinary drug.
Article 6 When applying for the registration of any new veterinary drug, the materials submitted shall be complete and standard and the data shall be authentic and reliable. In case any literature or materials are cited, the name of the works or periodicals and the volume, issue, and page shall be indicated; in the case of the literature or materials that have not been published to the general public, the certificate documents for allowing the use of the literature or materials by the owner shall be provided; in the case of foreign language materials, a Chinese version shall be provided as required.
When applying for the registration of any new veterinary drug, an applicant shall submit a guaranty, promising that no intellectual property right of any other person is infringed upon and that it shall be held liable for the consequences of the infringement, if any, and shall ensure the authenticity of the testing data it has obtained.
In case any overseas veterinary drug testing research materials are included in the application materials, the statements on the items and pages of the materials provided by the overseas research institution and the lawful registration certificate documents that have been notarized shall be attached.
Article 7 Under any of the following circumstances, the application for the registration of any new veterinary drug shall be rejected:
1. The applicant fails, within the monitoring period as announced by the Ministry of Agriculture, to prove that the data of the veterinary drug are obtained by itself;
2. The veterinary drug, other than the inactivated vaccine and the diagnosis product, which is produced through genetic engineering technology fails to pass the biological safety appraisal;
3. The application materials fail to meet relevant requirements and fail to be supplemented or corrected within a prescribed time limit; or
4. Other circumstances under which it shall not be accepted.
Article 8 The Ministry of Agriculture shall, within ten working days from the date when the application is accepted, submit the application materials for the registration of new veterinary drugs it decides to accept to the Veterinary Drug Appraisal Committee under the Ministry of Agriculture to make technical appraisal, notify the applicant to submit samples in three consecutive production batches and relevant materials as required for check and inspection, and send them to the designated veterinary drug inspection institute for check and inspection.
Where any new veterinary drug applied for is a biological product, an inspection shall be made on relevant strain virus, if necessary.
Article 9 The Veterinary Drug Appraisal Committee under the Ministry of Agriculture shall put forward appraisal opinions within 120 working days after receiving the materials and submit them to the Ministry of Agriculture.
Where it is necessary to supplement materials for the appraisal, an applicant shall supplement all relevant materials within six months from the date of receipt of the notice.
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