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Announcement of Ministry of Agriculture the 202nd (carry out " standard of anima
From;    Author:Stand originally
People's Republic of China announcement of Ministry of Agriculture
The 202nd date
Produce a standard to raise drug of our country animal, normative animal drug manufactures an activity, assure animal drug quality, enhance the international competition ability of animal drug industry, my ministry edits released " management of quality of animal drug production is normative " (Ministry of Agriculture the 11st order, the following abbreviation " standard of animal drug GMP " ) , apply since June 19, 2002. Carry out now " standard of animal drug GMP " concerned requirement announcement is as follows:
One, " standard of animal drug GMP " the basic standard that is animal drug production and quality management, be " animal drug regulation " the business is produced about animal drug in regulations of a series of form a complete set the incorporate, systematization of essential condition, standardization is stated. Come to was on December 31, 2005 from June 19, 2002 " standard of animal drug GMP " carry out excessive period, carry out compulsively since January 1, 2006 " standard of animal drug GMP " .
2, the main component that carrying out animal drug GMP lawfully is job of animal drug management, it is whole to animal drug production process carries out supervisory management, ensure the science of animal drug quality, significant step, also be those who get used to WTO to ask about system of visa of quality of drug of the animal in international trade is strategical measure. Department of administration of vet of each district pasturage and company of animal drug production should value job of animal drug GMP highly, carry out carry out " standard of animal drug GMP " it is good that as current center the job catchs grip, the animal drug that joins our region and company produces actual condition, make practical animal drug GMP implement a plan.
3, in view of the admittance condition that obtains animal drug GMP to stipulate the requirement is to be engaged in animal drug manufacturing an activity, consider at present animal drug produces the actual condition of the enterprise at the same time, the regulation has animal drug to produce (hold <> concurrently produce, similarly hereinafter) of the enterprise " animal drug produces licence " approve article date to be in with the product " standard of animal drug GMP " carry out transfer period inside continue effective, but " animal drug produces licence " , the nucleus of date of product approval article (change) hair job wants to work with GMP of executive animal drug union undertakes.
(one) , the company of animal drug production of new open must obtain certificate of approval of animal drug GMP rear can press formulary program to deal with " animal drug produces licence " reach a product to approve article order. Right by revoke " animal drug produces licence " the company is same by do an enterprise newly to treat.
(2) from June 19, 2002 period, the product that be added newly to the enterprise nucleus hair that did not obtain certificate of approval of animal drug GMP no longer and accepts the new animal drug that the technology makes over approves article order. The approval article number that because suffer,be punished to the enterprise and is cancelled is same by Xin Zengwen date is treated.
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