MHRA Marketing Authorisations Granted 15 to 30 April MHRA granted 4 OTC licences during 15-30 April 2025. MHRA Marketing Authorisations Granted 15 to 30 April
MHRA NIMAR Guidance Updated MHRA has published an updated version of the the Northern Ireland MHRA Authorised Route (NIMAR) guidance. This update includes revisions related to advertising and promotions, as well as information aligned with the Windsor Framework. NIMAR provides a route for the lawful supply of Prescription-Only Medicines in compliance with UK and EU rules, where there is a risk that clinical need in Northern Ireland for that product cannot be met. MHRA NIMAR Guidance Updated
MHRA RegulatoryConnect Webinar MHRA will be hosting a webinar on RegulatoryConnect on Thursday 22 May between 3.30-5pm. The aim of the webinar is to provide a comprehensive update on the programme, share plans for 25/26 and discuss some of the changes users will see, to help them prepare for the next release. MHRA also plan to share ongoing opportunities for feedback and involvement. MHRA RegulatoryConnect Webinar
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
