On 1 July 2011 the European Commission published the Falsified Medicines Directive (FMD) 2011/62/EU (external link) in the Official Journal of the European Union. The European Directive 2011/62/EU (“the Falsified Medicines Directive”) introduces measures to prevent the entry of falsified medicines into the legal supply chain. In very general terms the Falsified Medicines Directive:
– introduces the concept brokering for finished medicinal products and provides a new definition for brokering medicinal products
– introduces a requirement that brokers have to register with the Competent Authority of the EEA Member State in which they are established
– extends the requirement for a wholesale dealer’s licence for export of medicines to third countries
– extends existing obligations for wholesale dealers and provides new obligations, in particular reporting any suspected falsified medicines
– formalises current regulatory expectations for the manufacturer of the medicinal product to have audited their suppliers of active substances for compliance with the relevant Good Manufacturing Practice (“GMP”), and provides a solid legal basis in the Directive for the written confirmation of audit (the “QP Declaration”)
– introduces a formal requirement for manufacturers of medicinal products (or a third party acting under contract) to audit their suppliers of active substances for compliance with the requirements of Good Distribution Practice (“GDP”) particular to active substances
– formalises the regulatory expectation that manufacturers of the medicinal product will verify the authenticity and quality of the active substances and excipients they use
– introduces a new obligation on product manufacturers to inform the Competent Authority and marketing authorisation holder should the manufacturer obtain information that products (manufactured under the scope of the manufacturing authorisation) may be falsified, whether those products are being distributed through the legitimate supply chain, or by illegal means
– makes a number of significant changes to the controls on active substances and excipients intended for use in the manufacture of a medicinal product for human use, and in particular introduces two new definitions for active substances and excipients
– introduces a new requirement for manufacturers, importers and distributors of active substances to be registered with the Competent Authority of the Member State in which they are established
– introduces a new requirement for companies selling medicines at a distance to members of the public to be registered and a requirement for a common internet logo on their website.
The UK government is required to implement these changes in law and will be consulting on these measures as part of the process the MHRA is engaging with stakeholders. The collection of Q&As taken from the MHRA’s engagement with stakeholders on the 11 June 2012 at its first stakeholder meeting is now available.