Letter to Parliamentary Under-Secretary of State for Public Health and Prevention PAGB's letter to the Health Minister for EU and trade highlights concerns of supply disruption, loss of OTC medicines, and disincentives to licence medicines. Letter to Parliamentary Under-Secretary of State for Public Health and Prevention
MHRA Marketing Authorisations Granted 1 to 14 August MHRA granted 3 OTC licenses during 1-14 August 2024. MHRA Marketing Authorisations Granted 1 to 14 August
Defra- Extended Producer Responsibility (EPR) Fees Webinar Defra is hosting a webinar on EPR Fees. Defra- Extended Producer Responsibility (EPR) Fees Webinar
MHRA Marketing Authorisations Granted 15 July to 31 July 2024 MHRA granted 3 OTC licences during 15 – 31 July 2024. MHRA Marketing Authorisations Granted 15 July to 31 July 2024
MHRA – Medicines Pipeline Data MHRA is requesting that current or potential medicines Marketing Authorisation Holders provide information on planned or potential future submissions to MHRA. MHRA has published guidance which details how, what, and why MHRA require this data. MHRA – Medicines Pipeline Data
MHRA – Pre-submission Advice & Support MHRA has published guidance on pre-submission advice before applying for medicines Marketing Authorisations. MHRA – Pre-submission Advice & Support
MHRA Windsor Framework Readiness Message and DHSC Survey MHRA has shared a reminder of the preparations required regarding labelling changes under the Windsor Framework ahead of 1 January 2025. MHRA Windsor Framework Readiness Message and DHSC Survey
MHRA – Invoicing System Issue MHRA has discovered there is currently an IT issue which is causing the issuing of incorrect invoices. MHRA – Invoicing System Issue
MHRA – Windsor Framework Readiness Message MHRA has shared a reminder of the preparations required with respect to labelling changes under the Windsor Framework ahead of 1 January 2025. MHRA – Windsor Framework Readiness Message
EMA – Guideline on Good Pharmacovigilance Practices The European Medicines Agency (EMA) has published Guideline on good pharmacovigilance practices: Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures. EMA – Guideline on Good Pharmacovigilance Practices
Use of Real-World Evidence in Regulatory Decision Making – Second EMA Report Published A second report based on studies the European Medicines Agency (EMA) conducted using real-world data (RWD) between February 2023 and February 2024 has been published. The report summarises the progress made to enable the use of RWD and establish its value in regulatory decision-making by 2025. Use of Real-World Evidence in Regulatory Decision Making – Second EMA Report Published
MHRA & British Pharmacopoeia Reports MHRA has published the Annual conflict of interest compliance report 2023/24 and MHRA annual report and accounts 2023 to 2024. In addition, the British Pharmacopoeia Commission Annual Report 2023 has also been published. MHRA & British Pharmacopoeia Reports
