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- 上市许可Marketing license
- 药品上市后post-marketing drug
- 欧盟公民及居留许可持有者E. U OR EEA. Nationals and Residence Permit Holders
- 药品上市后评价post-marketing evaluation of drugs
- 使用同一个上市许可在不同厂址进行组装,不管何种情况,都要有一个人,通常是半成品生产厂家的合格的人员,对所有放行的成品批次承担整体责任。3 In all cases of assembly at different sites under a single marketing authorisation, there should be one person, normally a Q.P. of the manufacturer of the bulk production batch, who has an overall responsibility for all released finished product batches which are derived from one bulk production batch.
- 第三十七条 无需获权利持有人许可的活动Article 37 Acts Not Requiring the Authorization of the Right Holder
- 药品上市后安全性监测的现状与展望The present situation and prospect in post-marketing surveillance of drug safety
- 上市on the market
- 药品medicine
- 许可to allow
- 保险单持有人holder of policy
- 成品放行在上市许可中有基本要求。本附件条款不能凌驾于上市许可之上。The basic arrangements for batch release for a product are defined by its Marketing Authorisation. Nothing in this annex should be taken as overriding those arrangements.
- 药品上市后再评价技术规范及评价模式探讨A Study of the Regulations of the Re-evaluation Skills and Evaluation Modes for Drugs sold on the Market
- 保险单持有人或保单持有者Holder of an insurance policy or policy holder
- 例如,欧盟的上市许可可能会列出多个成员国内的厂址,某国的上市许可可能会列出多个厂址。For example a Community marketing authorisation may name batch release sites in more than one member state, and a national authorisation may also name more than one release site.
- 公司股份持有人。Holder of stock or of share in a company.
- 食品暨药物管理局说,想要在市场上贩卖菸草水的公司,应向该局提出新的药品上市申请书,以便审核。FDA said, companies that intend to market nicotine water should submit a new drug application to the agency for review.
- 执照持有人licensee
- 护照上的签字,允许持有人进入签字国。an endorsement made in a passport that allows the bearer to enter the country issuing it.
- 这是通过以药品上市后所获知的新资料为基础重新评药品风险,并建议能最适宜地应对该风险的方式来实现的。This is accomplished by reassessing drug risks based on new data learned after the drug is marketed, and recommending ways of trying to most appropriately manage that risk.