MHRA Update on ECDRP MHRA Update on ECDRP MHRA has issued an announcement in relation to the reliance route for centralised procedures.The European Commission... MHRA Update on ECDRP
PAGB Notification Scheme Guidance PAGB Notification Scheme Guidance PAGB’s notification scheme guidance has now been published on PAGB’s website and can be found on... PAGB Notification Scheme Guidance
Water Framework Directive – AESGP Position Published Water Framework Directive – AESGP Position Published The European Commission (EC) is proposing stronger rules on ambient air, surface and... Water Framework Directive – AESGP Position Published
PAGB Reclassification Guidance and Workshop PAGB Reclassification Guidance and Workshop PAGB’s first reclassification guidance: How to identify a reclassification candidate and prepare... PAGB Reclassification Guidance and Workshop
MHRA Publishes Marketing Authorisations Granted in 1 – 14 January 2023 MHRA Publishes Marketing Authorisations Granted in 1 – 14 January 2023 MHRA granted two licences during 1 – 14 January... MHRA Publishes Marketing Authorisations Granted in 1 – 14 January 2023
CTIS Virtual Public Event – Readiness for Mandatory Use of the Clinical Trials Regulation from 31 January 2023 CTIS Virtual Public Event – Readiness for Mandatory Use of the Clinical Trials Regulation from 31 January 2023 The Clinical... CTIS Virtual Public Event – Readiness for Mandatory Use of the Clinical Trials Regulation from 31 January 2023
EMA HMPC Meeting Report – November 2022 EMA HMPC Meeting Report – November 2022 EMA’s Committee on Herbal Medicinal Products (HMPC) has published the report from their... EMA HMPC Meeting Report – November 2022
MHRA Publishes Marketing Authorisations Granted between 15 – 31 December 2022 MHRA Publishes Marketing Authorisations Granted between 15 – 31 December 2022 MHRA granted one OTC licence between 15 – 31... MHRA Publishes Marketing Authorisations Granted between 15 – 31 December 2022
EMA Management Board – December 2022 Meeting Highlights EMA Management Board – December 2022 Meeting Highlights The European Medicines Agency (EMA) has published the highlights from its Management... EMA Management Board – December 2022 Meeting Highlights
MHRA – October & November 2022 Licensing Time-based Performance Measures Published MHRA – October & November 2022 Licensing Time-based Performance Measures Published MHRA publish data on the expected time taken to... MHRA – October & November 2022 Licensing Time-based Performance Measures Published
Request for a Preliminary Ruling to the European Court of Justice (Case C-616/20) – Distinction between Medicinal Product and Cosmetic Product – Court Judgment Request for a Preliminary Ruling to the European Court of Justice (Case C-616/20) – Distinction between Medicinal Product and Cosmetic... Request for a Preliminary Ruling to the European Court of Justice (Case C-616/20) – Distinction between Medicinal Product and Cosmetic Product – Court Judgment
EMA Publishes Revision of Nitrosamine Q&A EMA Publishes Revision of Nitrosamine Q&A The European Medicines Agency has published an updated guidance on the... EMA Publishes Revision of Nitrosamine Q&A
