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The Ministry of Agriculture edits " examination of animal drug GMP checks and ac
From;    Author:Stand originally

People's Republic of China announcement of Ministry of Agriculture
The 496th date
For GMP of drug of farther normative animal the examination checks and accept an activity, accelerate animal drug GMP to carry out a process, basis " animal drug regulation " and " animal drug produces quality management standard " , my ministry edited " quality of animal drug production manages normative examination to check and accept method " (the following abbreviation " method " ) , give now announce, apply from June 1, 2005. Former " quality of animal drug production manages normative examination to check and accept method " (announcement of Ministry of Agriculture the 267th) abolish at the same time. Be as follows with respect to concerned item announcement now:
One, cancel examination of static state of animal drug GMP since June 1, 2005, send through enterprise nucleus to checking check to close " certificate of animal drug GMP " period of efficacy all is 5 years.
2, build an enterprise to obtain " certificate of animal drug GMP " hind, should according to " animal drug regulation " and " date of article of approval of animal drug product runs way " stipulate to me the ministry applies for to deal with " animal drug produces licence " approve article order with the product.
Change extend enterprise to obtain " certificate of animal drug GMP " hind, should according to " animal drug regulation " and " date of article of approval of animal drug product runs way " stipulate to me the ministry applies for to change " animal drug produces licence " reach deal with add breed product newly to approve article order.
3, my ministry is opposite only " certificate of animal drug GMP " carry bright the product nucleus that level of state of drug of animal of attestation limits, basis produces sends a product to approve article order. The product classics that builds an enterprise to be used at producing test and verify to try to produce is legal of inspection agency certificate of proof, can be in obtain the product approves article order and try via approve of department of provincial vet administration after producing breed and amount, handle by eligible product, but this period of efficacy that approves a product must achieve standard of national animal drug to carry bright regulation of period of efficacy, sell inside period of efficacy, use.
Produce the product beyond level of animal drug state, according to " animal drug registers way " the regulation is dealt with.
4, the consistency that runs policy to maintain animal drug GMP, do good job to join, acceptable to passing static state of animal drug GMP to check before on June 1, 2005 enterprise, beard at " certificate of animal drug GMP " period of efficacy is full 3 months are forward department of provincial vet administration refers seat report of executive case of animal drug GMP.
20 jobs that department of provincial vet administration gets a report oneself finish what carry out a circumstance to enterprise GMP to supervise an examination in a few days, put forward to treat an opinion. Supervisory inspection report and processing opinion need to report me ministry and office of council of job of GMP of drug of animal of Ministry of Agriculture.
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