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”

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”