EMA System Demo: DADI and PMS EMA System Demo: DADI and PMS On 15 March 2022 EMA is hosting a system demo on the Digital Application... EMA System Demo: DADI and PMS
EMA SPOR Webinar EMA SPOR Webinar On 18 March 2022 the EMA substance, product, organisation and referential (SPOR) team is running a webinar... EMA SPOR Webinar
MHRA – January and February 2022 Licensing Time-based Performance Measures Published MHRA – January and February 2022 Licensing Time-based Performance Measures Published MHRA publish data on the expected time taken to... MHRA – January and February 2022 Licensing Time-based Performance Measures Published
CMDh – Summary of Activities in 2021 CMDh – Summary of Activities in 2021 The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has... CMDh – Summary of Activities in 2021
EMA Reinforced Role for Emergency Situations EMA Reinforced Role for Emergency Situations The Regulation (EU) 2022/123 of the European Parliament and of the... EMA Reinforced Role for Emergency Situations
EMA HMPC – Public Statement on Herbal Medicinal Products Containing Estragole Published EMA HMPC – Public Statement on Herbal Medicinal Products Containing Estragole Published The European Medicines Agency (EMA) Committee on Herbal... EMA HMPC – Public Statement on Herbal Medicinal Products Containing Estragole Published
CMDh February 2022 Meeting – Report CMDh February 2022 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published... CMDh February 2022 Meeting – Report
Annex 21 of EU GMP Guide – Importation of Medicinal Products – Final Version Published Annex 21 of EU GMP Guide – Importation of Medicinal Products – Final Version Published The European Commission has published... Annex 21 of EU GMP Guide – Importation of Medicinal Products – Final Version Published
EU Common Standard for Electronic Product Information – Adopted EU Common Standard for Electronic Product Information – Adopted The European Medicines Regulatory Network, following a public consultation, has adopted... EU Common Standard for Electronic Product Information – Adopted
Revision of the EU General Pharmaceuticals Legislation – Update Revision of the EU General Pharmaceuticals Legislation – Update The European Commission has published the outcome of the... Revision of the EU General Pharmaceuticals Legislation – Update
HMA 106th Meeting Highlights – November 2021 HMA 106th Meeting Highlights – November 2021 The Heads of Medicines Agencies (HMA) has published the highlights from their 106th... HMA 106th Meeting Highlights – November 2021
Digital Application Dataset Integration (DADI) Network Project Q&A Updated Digital Application Dataset Integration (DADI) Network Project Q&A Updated The European Medicines Agency (EMA) has published the updated Q&A on... Digital Application Dataset Integration (DADI) Network Project Q&A Updated