These Requirements for Veterinary Drug Change Registration Items and Application Materials are formulated in accordance with the Regulations on Veterinary Drug Administration and the Measures for Veterinary Drug Registration.
The change registration items that need to be reviewed and approved shall include: 1. Increase the target animal; 2. Increase the new indications or functional indications of veterinary drugs; 3. Change the veterinary drug content specification; 4. Change the production process of veterinary drugs; 5. Change the medicinal requirements of the veterinary drug prescription; 6. Change the origin of the drug substance of the veterinary drug preparation; 7. Amend the veterinary drug registration standard; 8. Change the validity period of the veterinary drug; 9. Change the origin of imported veterinary drugs; etc.
The change registration items that need to be reviewed and approved shall include: 1. Increase the target animal; 2. Increase the new indications or functional indications of veterinary drugs; 3. Change the veterinary drug content specification; 4. Change the production process of veterinary drugs; 5. Change the medicinal requirements of the veterinary drug prescription; 6. Change the origin of the drug substance of the veterinary drug preparation; 7. Amend the veterinary drug registration standard; 8. Change the validity period of the veterinary drug; 9. Change the origin of imported veterinary drugs; etc.
This Document is developed in accordance with the Regulations on Administration of Veterinary Drugs and the Measures for the Registration of Veterinary Drugs, providing for the requirements for registration information of veterinary drug changes.
Title:
Requirements for Veterinary Drug Change Registration Items and Application Materials.
Country:
China
Type of document:
Miscellaneous
Date of text:
2004