1, declare norms of an inject fluid to be 100ml beforehand: 0.3g; The norms that has appeared on the market is 100ml: 0.6g, can deny apply for 4 according to complement, is norms of modificatory medicines and chemical reagents declared register?

Answer: Declare an unit to should be made clear above all, the premise that declares compensatory application is: Declare an unit already permissive a norms of this breed appears on the market, undertake addition the application of norms on this foundation. Consider the rationality of a norms that complement increases even at the same time.

2, in register declare clinical when, be like,craft of preparation of raw material medicine reacts for much pace: → of B2 of → of B1 of A → ... → P, and when declaring production, already had intermediate body B1 (or B2, ... Bn) sale, excuse me:
A. OK from B1 of the body intermediate (or B2, ... Bn) produce for initiative raw material?
B. It is OK to be like, so to declaring manufacturing data He Xiu changes?

Answer: Promulgated 2005 " preparation of medicine of chemical medicaments raw material and structure are corroborant the instructor principle of research " in have a few principle regulations to the choice of initiative raw material: Initiative raw material should quality stability, can accuse, due of origin, standard and supplier examine report, should build according to the requirement of preparation craft when necessary inside control a standard.

If city makes work intermediate body B1 (or B2, ... Bn) accord with afore-mentioned principle requirements, can serve as initiative raw material, should offer this standard of craft of the proof offerring money of intermediate body, synthesis, quality and examine the report.

As a result of initiative raw material (or intermediate body) quality may be right eventually the quality of the product is influential, return Lv of take an examination to undertake sex of test and verify studies as follows commonly: (1) if the synthetic craft of body is mixed among this,quality standard all did not produce a change, need not undertake test and verify; (2) if the synthetic craft of body has among this,change, the constitution is measured among come true card, produce character to measure eventually (the key is comparative impurity circumstance) whether to agree with former technology, be opposite according to take into consideration the circumstances of craft change circumstance intermediate body, eventually the quality standard of the product undertakes editing (former technology untapped should be used in the synthesis of intermediate body for example organic dissolvent, lv of take an examination undertakes rudimental measuring checking) .
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