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The CMDh examines questions relating to the marketing authorisation of human medicines in two or more European Union (EU) Member States in accordance with the mutual recognition or the decentralised procedure, and questions concerning variations of these marketing authorisations.
- CMDh
CMDh. Coordination Group for Mutual Recognition and...
- CMDh
CMDh. Coordination Group for Mutual Recognition and Decentralised Procedures - Human: the group responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure.
19 de dic. de 2022 · The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected.
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La EMA anunció el pasado 4 de noviembre el lanzamiento del formulario electrónico de solicitud de variaciones para medicamentos de uso humano autorizados por procedimiento centralizado (Centralised Authorised Products, CAP).
Practical User Guide for Electronic Application Forms (eAF) for human and veterinary medicinal products in the EU. Version 1.8. Note to readers. This guidance reflects the current state of knowledge and is subject to future updates to take new information on-board.
The list of the CMDh Members and alternates, their professional qualifications and declarations of interest are published on the CMDh and EMA websites. The European Commission participates on a regular basis as an observer.
