eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00 and 09:00 on Friday, 29 September 2017 However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete. The Common Repository will also be [...]

Archive 2012 - 2020 Acronyms and abbreviations used in the CMDh documents

2023 - January-June - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures

The CMDh, in line with EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA), is phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic (see also EMA/EC/HMA announcement). This follows the end of the COVID-19 [...]

Ginkgo folium End of procedure: 12/05/2023 Date of publication: 28/07/2023

Lisdexamfetamine Date of publication: 28/07/2023

eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15:30 and 16:00 on Friday, 1 September 2017. However, Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed. If you have any [...]

An updated version of the eCTD v4.0 EU M1 Implementation Guide is available for public consultation. The commenting period has been extended to allow sufficient time for thorough review by pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities. The new date to submit your comments is 20th of October 2017. Please [...]

Pharmacovigilance Working Party Recommendations CMDh Recommendations Harmonisation of SmPCs - Article 30 Referrals Core SmPC/PL