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EMA guidelines

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[2018.02.16]Regulatory and procedural guideline: EudraVigilance web application (EVWEB) v.1.6 release notes 


[2018.02.15]Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes 


[2018.02.14]Regulatory and procedural guideline: EudraVigilance - National competent authorities - Adobe connect invitation  


[2018.02.14]Regulatory and procedural guideline: EudraVigilance - EVWEB user manual - Version 1.2 


[2018.02.14]Regulatory and procedural guideline: EudraVigilance - Marketing authorisation holders - Adobe connect invitation  


[2018.02.13]Regulatory and procedural guideline: Recommended submission dates for centralised and maximum-residue-limit procedures 


[2018.02.13]Regulatory and procedural guideline: Dates of 2018 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests  


[2018.02.09]Regulatory and procedural guideline: Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures 


[2018.02.09]Regulatory and procedural guideline: Member states contact points for review of national translations of Quick Response (QR) codes of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures 


[2018.02.09]Regulatory and procedural guideline: Qualification opinion - The European Cystic Fibrosis Society Patient Registry (ECFSPR), draft: consultation open 



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