Overview: According to the “Veterinary Drugs Management Regulations” and “Veterinary Drugs Production Quality Management Regulations (2020 Revision)”, the work arrangements for the implementation of the “Veterinary Drugs Production Quality Management Regulations (2020 Revision)” (hereinafter referred to as “Veterinary Drug GMP”) are announced as follows.
The “Veterinary Medicine Production Quality Management Regulations (Revised in 2020)” (Order of the Ministry of Agriculture and Rural Affairs [2020] No. 3) was issued on April 21, 2020, and will come into effect on June 1, 2020. According to the “Veterinary Drugs Management Regulations” and “Veterinary Drugs Production Quality Management Standards (Revised in 2020)”, the implementation of the “Veterinary Drugs Production Quality Management Standards (Revised in 2020)” (hereinafter referred to as “Veterinary Drug GMP”) implementation work schedule is as follows.
1. All veterinary drug manufacturing enterprises should meet the new veterinary drug GMP requirements by June 1, 2022. For veterinary drug manufacturing enterprises (production workshops) that do not meet the GMP requirements for the new version of veterinary drugs, their veterinary drug production licenses and veterinary drug GMP certificates are valid for a maximum of May 31, 2022.
2. From June 1, 2020, newly-built veterinary drug manufacturing enterprises and veterinary drug manufacturing enterprises rebuilding, expanding, or relocating their production workshops shall comply with the new veterinary drug GMP requirements.
3. From June 1, 2020, the provincial animal husbandry and veterinary authorities will accept applications from veterinary drug manufacturers in accordance with the new version of the GMP requirements for veterinary drugs. If the inspection and acceptance meet the requirements, the veterinary drug production license and veterinary drug GMP certificate will be valid for 5 years; Accepting applications for veterinary drug manufacturing enterprises due for renewal of licenses and in accordance with the requirements for veterinary drug GMP issued in 2002. If the inspection and acceptance meet the requirements, the veterinary drug production license and the veterinary drug GMP certificate are valid until May 31, 2022.
4. For applications that have been accepted before June 1, 2020, complete the relevant work in accordance with the original regulations and issue veterinary drug production licenses and veterinary drug GMP certificates. The certificate is valid until May 31, 2022
