Supplementary Guidance for Pharmaceutical Wholesalers on the Windsor Framework The MHRA and DHSC have published guidance providing supplementary information for pharmaceutical wholesalers regarding the Windsor Framework. Supplementary Guidance for Pharmaceutical Wholesalers on the Windsor Framework
Defra – pEPR Recyclability Assessment Methodology & Webinar The Extended Producer Responsibility for packaging (pEPR) Recyclability Assessment Methodology (RAM) has been published by Defra and the pEPR Scheme Administrator. Defra is organising a webinar on 16 January 2025 (2-4pm) on the Base Fees and the RAM methodology and approach to reporting. Defra – pEPR Recyclability Assessment Methodology & Webinar
AESGP, EFPIA and Medicines for Europe Position Papers on ePI The Association of the European Self-Care Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe have issued a series of position papers on electronic Product Information (ePI). These aim to advocate for the implementation of ePI and improvement of the patient leaflet content, in the discussions on the Pharmaceutical Legislation Review. AESGP, EFPIA and Medicines for Europe Position Papers on ePI
MHRA Windsor Framework Guidance Updates MHRA has updated some guidance documents to reflect changes resulting from the Windsor Framework. MHRA Windsor Framework Guidance Updates
Understanding the Life Sciences Innovative Manufacturing Fund (LSIMF) Webinar Join us for an exclusive webinar on 30 January with the Office for Life Sciences to delve into the new Life Sciences Innovative Manufacturing Fund (LSIMF). This session is designed to help you navigate the Fund application process from start to finish. Understanding the Life Sciences Innovative Manufacturing Fund (LSIMF) Webinar
Understanding the pEPR Scheme: Implications for Industry and Preparation for PAGB Members PAGB members are invited to an exclusive webinar on Thursday 23 January that will delve into the Extended Producer Responsibility for packaging (pEPR) Scheme. The session will feature a presentation delivered by officials from Defra. Understanding the pEPR Scheme: Implications for Industry and Preparation for PAGB Members
New MHRA Chair Starts Role & Outlines Priorities Professor Anthony Harnden has officially started his role as Chair of MHRA. He will be particularly focused on helping MHRA protect patient safety through robust safety surveillance systems, embrace risk-proportionate regulation and foster an inclusive workplace. New MHRA Chair Starts Role & Outlines Priorities
Defra – pEPR Recyclability Assessment Methodology & Webinar The Extended Producer Responsibility for packaging (pEPR) Recyclability Assessment Methodology (RAM) has been published by Defra and the pEPR Scheme Administrator. Defra is organising a webinar on 16 January 2025 (2-4pm) on the Base Fees and the RAM methodology and approach to reporting. Defra – pEPR Recyclability Assessment Methodology & Webinar
MHRA Medicines: Updated Guidance on Product Reclassification The MHRA has updated the guidance "Medicines: Reclassify your Product", incorporating the webinar recording of the MHRA reclassification process for medicines in the UK, which took place in November 2024. MHRA Medicines: Updated Guidance on Product Reclassification
MHRA Category 1 List Following Implementation of Windsor Framework MHRA has published the Category 1 list which is an initial list of authorised products on or before 30 November 2024 assigned to Category 1. It will be updated early January 2025 to include all authorised products up to and including 31 December 2024 that fall in Category 1. MHRA Category 1 List Following Implementation of Windsor Framework
MHRA Windsor Framework Guidance Updates MHRA has updated some guidance documents to reflect changes resulting from the Windsor Framework, including the guidance on variations to marketing authorisations (MAs) and on the unfettered access procedure for marketing authorisations approved in Northern Ireland. MHRA Windsor Framework Guidance Updates
EU – COMBINE Program for Clinical Trials and Medical Devices Member State authorities have approved a new strategy for the COMBINE programme. EU – COMBINE Program for Clinical Trials and Medical Devices
