the centralised procedure provide the basis for theauthorisation of medicinesin Europe. The committees andworking partiesalso contribute to thedevelopment of medicinesand medicine regulation, by: 通过集中评审程序递交的上市许可申请 的委员会评估为药品在 欧盟上市许可提供基础,委员会和工作组也致力于药品和药品...
In the centralised procedure, the CHMP is responsible for:conducting the initial assessment of EU-wide marketingauthorisation applications;assessing modifications or extensions ('variations') to an existingmarketing authorisation;considering the recommendations of the Agency's Pharmacovigilance Risk Assessment ...
? More information about fees and fee payment in the Centralised Procedure For Type II variations, if the variation is considered ‘invalid’ (i.e. an assessment process can not be started), an administrative fee will be charged by the Agency (see also Explanatory note on fees payable to ...
欧盟药监局(EMA)-药品检查工作组-年度报告-2010 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8595 E-mail info@ema.europa.eu Website www.ema.europa.eu © European ...
20 The European Pharmacopoeia and certificates of suitability (CEP) The CEP procedure (cont.) Provides: • Centralised assessment - saves time and resources • Information on the need to update Ph. Eur. monographs • Facilitates management of MAAs and variations • Application submitted ...
84 Human Medicines Evaluation Division European Medicines Agency post-authorisation procedural advice for users of the centralised procedure This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the post-authorisation guidance ...
需要金币:*** 金币(10金币=人民币1元) 欧洲药监局2021年度报告EMA :2021-annual-report-european-medicines-agency_en.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 ANNUAL REPORT 2021 The European Medicines Agency’s contribution to science, medicines and health in 2021 An agency ...
EMA_欧洲药典和CEP证书介绍PPT