EMA Variation Guideline Revision – Stakeholder Consultation The European Medicines Agency (EMA) has launched a stakeholder consultation on the revised European Commission guidelines on variations categories and procedures. EMA Variation Guideline Revision – Stakeholder Consultation
PAGB Food Supplements Regulatory Workshop The next PAGB Food Supplements Regulatory workshop will be held via Microsoft Teams on Thursday 4 July from 10am – 4pm. PAGB Food Supplements Regulatory Workshop
PMS PUI Read-only Mode Live on PLM Portal The read-only mode of the Product Management Service (PMS) is available for registered users and can be accessed through the Product User Interface (PUI) - live on the Product Lifecycle Management (PLM) Portal. Throughout June 2024, the PMS team will be running Q&A clinics on PUI. PMS PUI Read-only Mode Live on PLM Portal
PAGB Introduction to CBD Workshop The next PAGB Introduction to CBD workshop will be held via Microsoft Teams on Wednesday 5 June from 10am – 1pm. PAGB Introduction to CBD Workshop
MHRA Board Members and Committee Lists Updated The MHRA has updated the board members and committee list on their website. MHRA Board Members and Committee Lists Updated
ESMP Webinar The European Medicines Agency (EMA) is organising a series of events throughout 2024 and 2025 for stakeholders on the European Shortages Monitoring Platform (ESMP). The first webinar is scheduled for 24 June. ESMP Webinar
MHRA Marketing Authorisations Granted 1 to 14 May 2024 MHRA granted 6 OTC licenses during 1 - 14 May 2024. MHRA Marketing Authorisations Granted 1 to 14 May 2024
Brexit Working Group Meeting Michelle Riddalls, CEO of PAGB, hosted an ad hoc meeting of the EU Exit Working Group to update on the EU Acquis implementation for medicines within the Windsor Framework. Brexit Working Group Meeting
EMA Q&A Document on Article 117 – 4th Revised Version Published EMA has published the fourth revised version of its questions & answers document on Article 117 MDR (practical considerations concerning combination products). EMA Q&A Document on Article 117 – 4th Revised Version Published
Changes to the way the UK ePI Task Force works The 3 trade associations leading the UK ePI Task Force - PAGB, ABPI and BGMA - have provided an update on how the Task Force will operate in the future. Changes to the way the UK ePI Task Force works
MHRA PIQU RFI Update The MHRA PIQU team has confirmed going forwards only 1 Request for Further Information (RFI) letter will be issued. MHRA PIQU RFI Update
Smarter Regulation Update DBT has published two policy papers "Smarter Regulation: Delivering a regulatory environment for innovation, investment and growth" and "Smarter Regulation: One Year On – May 2024". Smarter Regulation Update
