Requirements for Veterinary Drug Change Registration Items and Application Materials.
Country
Type of law
Miscellaneous
Abstract
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.
Attached files
Web site
Date of text
Repealed
No
Source language
English
Legislation Amendment
No
Original title
兽药变更注册事项及申报资料要求.