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

A defect in section 1.1 of the MAA human eAF, affecting the PRAC rapporteur field (Centralised Procedure applications) has been detected and subsequently fixed. New version v.1.20.0.1 of the MAA human form and the updated release notes are now available

Referral decisions and new product information changes can be found on: the European Commission website - (EU languages only) this includes (Union) referral procedures (in accordance with articles 29(4); 30; 31(1); 31(2) or 107i of Directive 2001/83. EMA website – (EU and EEA languages) all procedures, including CMDh positions on PRAC (Union) referrals for solely nationally [...]