记者11月5日从国家食品药品监督管理局获悉,由其印发的《药品和医疗器械行政处罚裁量适用规则》将于2013年1月1日起施行。届时,生产销售假劣药等行为给予从重处罚和按照“情节严重”处罚的界定更清晰。

On November 5, reporter from the state food and drug supervision bureau,By its issued by[Drugs and medical devices administrative penalty discretion applicable rules]In 2013 will be on January 1,.the,Production sales JiaLie drugs shall be given heavier punishment according to the given behavior and"If the circumstances are serious"The definition of the punishment more clearly.

　　规则指出,对当事人依法给予从重处罚的情形主要包括:以麻醉药品、精神药品、医疗用毒性药品、放射性药品冒充其他药品,或者以其他药品冒充上述药品的；生产、销售以孕产妇、婴幼儿及儿童为主要使用对象的假药、劣药的；生产、销售的生物制品、血液制品、注射剂药品属于假药、劣药的；生产、销售、使用假药、劣药或者不符合标准的医疗器械,造成人员伤害后果的等。

Rules pointed out that,On the parties concerned shall be given a heavier punishment situation mainly include: to narcotic drugs/Psychotropic drugs/Toxic drugs for medical use/Radioactive drugs pretend to be other drugs,Or by other drug pretend to be the above drug;production/Sales in the maternal/Infants and children as the main use object of counterfeit drugs/Inferior drugs;production/Sales of biological products/Blood products/Injection drug belong to counterfeit drugs/Inferior drugs;production/sales/Use of counterfeit drugs/Inferior drugs or do not conform to the standards of medical devices,Causing injuries consequences, etc.

　　对当事人按照“情节严重”处罚的情形主要包括:药品生产中非法添加药物成份或者违法使用原料,生产的药品为假药的；药品生产中违法使用辅料,生产的药品为劣药,造成严重后果的；药品、医疗器械生产企业发现其生产的药品或者医疗器械存在安全隐患,可能对人体健康和生命安全造成损害,不通知销售者停止销售,不告知消费者停止使用,不主动召回产品,不向食品药品监督管理部门报告,造成严重后果的；药品、医疗器械经营企业发现其销售的药品或者医疗器械存在安全隐患,可能对人体健康和生命安全造成损害,不立即停止销售该产品,不通知生产企业或者供应商,不向食品药品监督管理部门报告,造成严重后果的等。(记者胡建辉)

On the parties in accordance with the"If the circumstances are serious"Punishment situation mainly includes: pharmaceutical production illegally added drug ingredients or illegal use of raw materials,The production of drugs for the fake medicines;Drug production illegal use of complementary makings,The production of drugs for medicines of inferior quality,Serious consequences;drugs/Medical device manufacturing enterprise find the production of drugs or medical devices exist safety hidden trouble,May the human health and life safety damage,Do not inform the seller to stop sales,Don't tell the consumer stop using,Do not take the initiative to recall the products,Not to the food and drug supervision and administration department report,Serious consequences;drugs/Medical equipment management enterprise found its sales drugs or medical devices exist safety hidden trouble,May the human health and life safety damage,Don't immediately to stop selling the products,Don't inform production enterprise or suppliers,Not to the food and drug supervision and administration department report,Serious consequences, etc.(Reporter HuJianHui)