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picture1_Marketing Ppt 67718 | Presentation Marketing Authorisation V1 En


picture2_Marketing Ppt 67718 | Presentation Marketing Authorisation V1 En picture3_Marketing Ppt 67718 | Presentation Marketing Authorisation V1 En

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File: Marketing Ppt 67718 | Presentation Marketing Authorisation V1 En
Marketing authorisation: Main principles (1) European Patients’ Academy on Therapeutic Innovation A medicinal product may only be placed on the market in the European Economic Area (EEA) after a marketing ...

icon picture PPTX Filetype Power Point PPTX | Posted on 28 Aug 2022 | 2 years ago
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...Marketing authorisation main principles european patients academy on therapeutic innovation a medicinal product may only be placed the market in economic area eea after ma has been issued by competent authority of that member state ms or commission scientific assessment medicines agency ema process for obtaining is very complex and highly regulated principle underlying pharmaceutical legislation protection public health mas products are dynamic dossier supporting an must regularly updated order to ensure progress new regulatory requirements respected any information influence evaluation benefits risks promptly supplied application common technical document ctd applicant submits maa which demonstrate required quality it safe efficacious adhere set specifications internationally agreed format followed applications intended submitted authorities determines appropriate data applicable all types maas irrespective type procedure organised five modules constitute actual module differs accordi...
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