MHRA – Patient Involvement Strategy: An Assessment of Progress MHRA has published an assessment of progress made in delivering the Patient Involvement Strategy between October 2021 - January 2025. MHRA – Patient Involvement Strategy: An Assessment of Progress
New EU Rules on Health Technology Assessment On 12 January, the Regulation on Health Technology Assessment (HTA) became applicable in the EU. The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. New EU Rules on Health Technology Assessment
MHRA Marketing Authorisations Granted 15 to 31 December MHRA granted 3 OTC licences during 15-31 December 2024. MHRA Marketing Authorisations Granted 15 to 31 December
Transition to IRIS for Post-Authorisation Procedure Management The transition to the IRIS platform for managing post-authorisation procedures has successfully gone live. Transition to IRIS for Post-Authorisation Procedure Management
AESGP Webinar: Navigating the AI Act for Non-Prescription Medicines and Self-Care Medical Device Manufacturers – Challenges and Opportunities Join AESGP's webinar, "Applicability of AI Act for Non-Prescription Medicines and Self-Care Medical Devices Manufacturers: Challenges and Opportunities," on Thursday, 23 January, to explore the implications, challenges, and opportunities of the AI Act for the self-care sector. AESGP Webinar: Navigating the AI Act for Non-Prescription Medicines and Self-Care Medical Device Manufacturers – Challenges and Opportunities
Safety and Security Declarations for Goods Imported from the EU to Great Britain Starting January 2025, Safety and Security declarations will be mandatory for all imports from the EU into GB.. Safety and Security Declarations for Goods Imported from the EU to Great Britain
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
