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Carry out the announce of catalog management about exporting medicines and chemi
From;    Author:Stand originally

The country feeds medical inspect to do [2008]595 date is those who strengthen pair of exit medicines and chemical reagents and medical apparatus and instruments to superintend, ensure product quality is safe, according to " Pharmaceutical Affairs Law " and " the special provision that the State Council controls government about enhancing the product security such as food " , national provision medicines and chemical reagents supervises management board to decide to export medicines and chemical reagents and production of breed of medical apparatus and instruments to carry out catalog management to the part, need to make according to supervising management to work, release, adjust " catalog of superintendency breed of exit medicines and chemical reagents and medical apparatus and instruments " (next weighing " breed catalog " ) . Be as follows specific arrangements announce now:

One, first " breed catalog " close carry 2 kinds of medicine of raw material of 9 kinds of medicines and chemical reagents and preparation, medical apparatus and instruments (see accessory) .

2, production " breed catalog " inside the company that exports medicines and chemical reagents, supervisory management of production of according to drug applies for about the regulation and ought to obtain " medicines and chemical reagents produces licence " , according to medicines and chemical reagents registers management to apply for and obtain medicines and chemical reagents to approve article order about the regulation, attestation of standard of management of quality of production of according to drug manages concerned regulation to apply for and obtain " certificate of GMP of medicines and chemical reagents " , should apply for by the regulation before exit " medicines and chemical reagents sells certificate " .
Production " breed catalog " inside the company that exports medical apparatus and instruments, supervisory management of production of according to medical apparatus and instruments applies for about the regulation and ought to obtain " license of company of production of medical apparatus and instruments " , according to medical apparatus and instruments registers management to apply for and obtain medical apparatus and instruments to register certificate about the regulation.

3, this announce rises two years from released day inside, produce or accept manufacturer of the pharmacy outside the condition to entrust treatment " breed catalog " inside the company that exports breed, all should clutch deal with afore-mentioned declaring matters concerned. After two years, the enterprise of afore-mentioned requirements does not get short of production, sale " breed catalog " inside exit breed.

Hereby announce.


Accessory: Exit medicines and chemical reagents and medical apparatus and instruments superintend breed catalog


National provision medicines and chemical reagents controls management board
Two years of October seventeen days
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