Measures for the Registration of Veterinary Drugs.
Country
Type of law
Regulation
Abstract
These Measures aim at ensuring the safety, effectiveness and quality control of veterinary drugs and regulating the acts of veterinary drug registration. The Text consists of 45 Articles divided into 9 Chapters: General Provisions (I); Registration of New Veterinary Drugs (II); Registration of Imported Veterinary Drugs (III); Registration of Veterinary Drug Change (IV); Veterinary Drug Check and Inspection (V); Re-registration of Veterinary Drugs (VI); Veterinary Drug Standard Substance Management (VII); Penalties (VIII); Supplementary Provisions (IX).
The Ministry of Agriculture shall be responsible for the 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. The Measures further provide for the conditions, procedures and requirements to be satisfied for application, appraisal of registration of new veterinary drugs, imported veterinary drugs, change of veterinary drugs, and re-registration thereof, etc. 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 the relevant materials in accordance with the Requirements for the Registration Materials of Veterinary Drugs. When exporting any veterinary drug to China for the first time, the office of the export party within the territory of China or the agency entrusted by it within the territory of China shall file an application to the Ministry of Agriculture, fill in the Application Form for Veterinary Drug Registration, and submit the relevant materials in light of the Requirements for Registration Materials of Veterinary Drugs. When applying for exporting biological products for animal use to China, an applicant shall also provide such relevant materials and documents as bacterium (virus or insect) seeds or cells, etc.
The Ministry of Agriculture shall be responsible for the 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. The Measures further provide for the conditions, procedures and requirements to be satisfied for application, appraisal of registration of new veterinary drugs, imported veterinary drugs, change of veterinary drugs, and re-registration thereof, etc. 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 the relevant materials in accordance with the Requirements for the Registration Materials of Veterinary Drugs. When exporting any veterinary drug to China for the first time, the office of the export party within the territory of China or the agency entrusted by it within the territory of China shall file an application to the Ministry of Agriculture, fill in the Application Form for Veterinary Drug Registration, and submit the relevant materials in light of the Requirements for Registration Materials of Veterinary Drugs. When applying for exporting biological products for animal use to China, an applicant shall also provide such relevant materials and documents as bacterium (virus or insect) seeds or cells, etc.
Attached files
Web site
Date of text
Repealed
No
Source language
English
Legislation Amendment
No
Original title
兽药注册办法.
Implemented by