Falsified Medicines Directive in the EU
pharmafile | April 23, 2012 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing |Â Â Â
Dated 16 April 2012, the European Commission has issued the Draft Template for the Written Confirmation for Active Substances Imported into the European Union for Medicinal products for Human Use, for public consultation. This document provides the proposed template to be used by the regulatory authority in the exporting country outside the EU in order to confirm GMP and standards at least equivalent to those in the EU, and is one of the publications set to provide information regarding the practical implementation of the new measures to come into force under the Falsified Medicines Directive (Directive 2011/62/EU). Other measures of the new Directive include:
· Mandatory authenticity features on the packs of certain medicines.
· Enhanced requirements for record keeping by wholesale distributors and reporting of suspected falsified medicines through the supply chain.
· Risk analyses with regard to pharmaceutical excipients.
If you are wholesale dealer, manufacturer or marketing authorisation holder and would like to understand how the new provisions are likely to impact you, please contact us at enquiries@wainwrightassociates.co.uk or telephone +44 (0)1628 530554.






