In light of an increased occurrence of medicinal product shortages over the last few years, the EMA has published a reflection paper to provide a plan to help deal with manufacturing-related supply issues. Read more “EMA Publishes Plan to Help Deal With Manufacturing-Related Medical Product Supply Shortages”
Year: 2012
Regulatory news – Changes to PIL mock-ups accepted by the MHRA
The MHRA has announced that as of the 31st January 2013 that they will not progress submissions that have personal information incorporated into PIL mock-ups. Read more “Regulatory news – Changes to PIL mock-ups accepted by the MHRA”
EMA publish EURD List
The EMA has published the list of EU reference dates and frequency of submission of periodic safety update reports (PSUR) known as the ‘EURD list’.
More information can be found here.
Shortlisted for 3 2012 TOPRA awards
Regulis is delighted to announce that 3 team members have been shortlisted for an award from our professional body – TOPRA (The Organisation for Professional in Regulatory Affairs) by an eminent judging panel. Read more “Shortlisted for 3 2012 TOPRA awards”
Introduction of the new black intensive monitoring symbol
The Pharmacovigilance Risk Assessment Committee (PRAC) is an EU committee which has been formed since implementation of the new Pharmacovigilance (PhV) regulations and they have the responsibility for determining which products will be under intensive surveillance and what the intensive monitoring symbol will be. Read more “Introduction of the new black intensive monitoring symbol”
Revised MHRA BROMI Notification Scheme – How is it working so far?
The MHRA have reviewed how the BROMI Notification scheme has been working since it was expanded in July 2012 to include changes to labelling and patient information leaflets. Read more “Revised MHRA BROMI Notification Scheme – How is it working so far?”
Guidance on Submissions to the MHRA from 1st January 2013 – Details announced!
The MHRA has confirmed the new arrangements for making submissions. The changes go further than expected. Read more “Guidance on Submissions to the MHRA from 1st January 2013 – Details announced!”
EMA & EMCDDA sharing information
European Medicines Agency enhances cooperation with EU drug-monitoring agency on psychoactive and abused medicines. Read more “EMA & EMCDDA sharing information”
PIL & Labelling Changes
Changes to Patient Information Leaflets and Labelling. Under Article 61(3) of Council Directive 2001/83/EC, MA holders must inform the competent authority of all changes to labelling and patient information leaflets which are not connected with changes to the Summary of Product Characteristics (SPC). Read more “PIL & Labelling Changes”
Draft QRD Template
Updated QRD Template – EU Consultation until 17th August 2012. A revised human medicines QRD (Quality Review of Documents) template for Centralised products has been drafted which addresses the requirements outlined in the recently published Pharmacovigilance Legislation. Read more “Draft QRD Template”