EU Council adopts the Falsified Medicines Directive

Recently, the EU Council adopted the Falsified Medicines Directive. The directive reflects substantial changes regarding GMP and GDP (good distribution practices) for both finished product, API, and excipients. The objective of the revised directive is to prevent the entry into the legal supply chain of drug product any API or excipient that is falsified relative to its identity, history or source. Although this is an EU directive, we anticipate that the US will follow suit within the next year or so. There has been significant communication of late, from FDA, about protection of the supply chain. The publication by the Council of the European Union summarizes the expectations of this new directive.

Highlights of the changes:

  • Imported APIs from non-EU origin must be accompanied by a written confirmation of compliance unless: the exporting country is on the list of equivalent countries; and, for exceptional reasons of a medicine’s availability and when the EU GMP certificate is not older than 3 years and the European Commission is informed.
  • Manufacturers, importers, distributors and brokers of APIs must register their activities with the Competent Authority where the operator is established. Annual notification of changes is mandatory. Changes impacting quality or safety have to be notified immediately.
  • Harmonization of safety features for APIs, excipients and medicinal products to allow verification of the authenticity and identification of individual packs, and provide evidence of tampering.
  • The final dosage form manufacturer must perform a formal risk assessment to establish which GMP requirements should apply to the excipients used for drug product manufacture. The drug manufacturer should consider the source of the excipients, the intended use and previous quality incidents have to be taken into account.

This document implies that a more rigorous audit program should be considered to ensure that good manufacturing practices are complied with for all API and excipient manufacturers, distributors, and repackagers. This is in line with what we are seeing on the US front from FDA as well.