CMDh April 2025 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 23-24 April 2025. CMDh April 2025 Meeting – Report
AESGP Webinar – Ethanol BPR & CLP Procedures Impact on Self-care Products Greece has submitted a CLH Registry of Intention for Ethanol hazard classification including Repr. 2. To explore the potential impact of a CMR1A or CMR1B classification on self-care products, AESGP is hosting a webinar on Thursday 15 May 12.30–13.30 CEST. AESGP Webinar – Ethanol BPR & CLP Procedures Impact on Self-care Products
MHRA Webinar on Medicines Licensing: New National Assessment Procedure for Medicines MHRA is hosting a webinar on Medicines Licensing: New National Assessment Procedure for Medicines on Tuesday 6 May 2025, 10:00 - 11:00 BST. MHRA Webinar on Medicines Licensing: New National Assessment Procedure for Medicines
MHRA Questionnaire – Windsor Framework Use of ‘UK only’ Stickering The option to apply 'UK Only' stickers to medicines will end on 30 June 2025. MHRA has requested that companies complete a questionnaire to help them assess preparedness for the transition away from ‘UK Only’ stickering. MHRA Questionnaire – Windsor Framework Use of ‘UK only’ Stickering
MHRA Marketing Authorisations Granted 1 to 14 April MHRA granted 6 OTC licences during 1 - 14 April 2025. MHRA Marketing Authorisations Granted 1 to 14 April
New Guidance for HMA-EMA Catalogues of RWD Sources and Studies New guidance has been published to provide best practices for users of the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) Catalogues of real-world data (RWD) sources and studies (RWD Catalogues). The RWD Catalogues, launched a year ago, aim to enhance transparency and access to RWD for research and regulatory purposes. New Guidance for HMA-EMA Catalogues of RWD Sources and Studies
EMA – QRD Template & KIS Consultations The European Medicines Agency (EMA) has released the draft revised QRD template for consultation, the deadline is 31 August. In addition, EMA is running a public consultation on the potential inclusion of a ‘key information section’(KIS) in the package leaflet of centrally authorised medicines. The deadline is 31 May. EMA – QRD Template & KIS Consultations
Consultation on Draft Revised EU Herbal Monographs for Garlic, Arnica and Hawthorn Draft revised EU herbal monographs on Garlic, Arnica Flower and Hawthorn Leaf and Flower have been published for public consultation. Consultation on Draft Revised EU Herbal Monographs for Garlic, Arnica and Hawthorn
CHM Appointments Professor Claire Stewart has been appointed as a commissioner of the Commission on Human Medicines (CHM) for 4 years from 3 March 2025. In addition, 3 other commissioners have been reappointed, with their new terms due to begin in May. CHM Appointments
MHRA Performance Data – March 2025 The Medicines and Healthcare products Regulatory Agency (MHRA) has published its performance data for March 2025. MHRA Performance Data – March 2025
MHRA Statement on Products Containing Cannabidiol (CBD) The Medicines and Healthcare products Regulatory Agency (MHRA) has published its opinion on the regulatory status of products containing CBD. MHRA Statement on Products Containing Cannabidiol (CBD)
EMA Consultation – Reflection Paper Linking to ePI from EU Medicine Packages The European Medicines Agency (EMA) has released for public consultation its Reflection paper on linking to electronic product information (ePI) from EU medicine packages. The official deadline for comments is 30 June 2025. EMA Consultation – Reflection Paper Linking to ePI from EU Medicine Packages
