Carry out catalog management to concern about exporting medicines and chemical reagents and production of medical devices to the part

Dina Martina - Medical College Commercial

The inspect that feed medicine does [2008]168 date

Released on November 3, 2008

Medicines and chemical reagents of food of each province, municipality, municipality directly under the Central Government controls management board (medicines and chemical reagents controls management board) :

To strengthen pair of superintendency that export medicines and chemical reagents and medical devices, 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 bureau decides to export medicines and chemical reagents and breed of medical devices to carry out catalog management to the part, already released " the announce that carries out catalog management about exporting medicines and chemical reagents and production of medical devices to the part " (next weighing " announce " ) . Will inform as follows about specific arrangements now:

One, national bureau needs according to supervising management to work, make, release, adjust " catalog of superintendency breed of exit medicines and chemical reagents and medical devices " (next weighing " breed catalog " ) . First " breed catalog " close carry 2 kinds of medicine of 9 kinds of raw material and preparation, medical devices.

2, " announce " after releasing, production " breed catalog " inside the company that exports medicines and chemical reagents, concerned regulation of supervisory government of active medicines and chemical reagents applies for according to in time and ought to obtain " medicines and chemical reagents produces licence " , date of drug approval article and " certificate of GMP of medicines and chemical reagents " ; Before the enterprise that accords with a requirement is exported, should apply for by the regulation " medicines and chemical reagents sells certificate " . Production " breed catalog " inside the company that exports medical devices, ought to active medical devices supervises according to to management applies for in time about the regulation and be obtained " license of company of production of medical devices " register certificate with medical devices.

3, save each please (area, city) medicines and chemical reagents of the exit inside area under administration of understanding of investigation of superintendency bureau of food medicines and chemical reagents and situation of production of medical devices, conduct propaganda " announce " requirement, supervise and urge concerned production company clutchs according to " announce " the requirement deals 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, also must not entrust means in order to accept firm of the pharmacy outside the condition to machine " breed catalog " inside exit medicines and chemical reagents.

If discover a problem,each district is in in the job, sign up for national bureau in time please.

National provision medicines and chemical reagents supervises management board office
28 years on November 3

Medicine of 9 kinds of raw material and preparation are: Vitriolic gentamicin, a holds cut down in the palm he lows reach its salt, xidena blame and its salt, abstruse department his Wei and its salt, qu Song of Bao of ketone of head Bao Pai, head reachs its salt, glycerine, heparin reachs its salt, green Hao element and its ramification (include aether of armour of ester of Hu of element of Shuang Qingqing Hao, Qing Hao, Hao to wait) , get used to disease or function advocate treat to erect functional obstacle or the Chinese traditional medicine that enhance sexual function preparation. 2 kinds of medical devices are: Dextrose checks, bring complete set.

Announcement requirement, the sun of initiative cloth rises two years 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.