MHRA Updates Guidance on the Submission of Nitrosamine Risk Evaluation Update on MHRA’s submission of nitrosamine risk evaluation guidance, step 2 links updated In accordance with the... MHRA Updates Guidance on the Submission of Nitrosamine Risk Evaluation
MHRA Publishes Marketing Authorisations Granted in February 2022 MHRA’s list of marketing authorisations granted in February 2022 MHRA granted six OTC licences in February 2022. Details of these... MHRA Publishes Marketing Authorisations Granted in February 2022
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
