News

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”

Beyond the Call of Duty

One element of Pharmaceutical and Healthcare companies striving to adjust their business model and maintain their competitiveness, is an increasing trend to outsourcing.  In such circumstances the quality of the support provided is critically important.  Read more “Beyond the Call of Duty”