Industry news

Update on implementation of EU FMD

Europe’s Falsified Medicines Directive (FMD) requires that from 2 July 2025 all APIs imported into the EU have to be certified as meeting EU GMP by a Competent Authority of the exporting country unless they have applied to the European Commission to be listed as an acceptable country.

The US FDA has just applied to be listed. To date the only country approved to go onto the list is Switzerland.

The Commission has published an “Implementing Decision”, dated 24 January 2013, on the assessment of a third country’s regulatory framework applicable to APIs. This provides confirmation of the criteria to be assessed when a country applies to go onto the Commission’s list of acceptable countries; the criteria are:

• The GMP standard being applied is equivalent to that given in Part 2 of the EU GMP Guide; i.e. ICH Q7
• The inspection resources, the qualification and training of inspectors, inspection procedures, inspection strategies and mechanisms to address conflicts of interest, inspection performance standards, enforcement powers, alert and crisis mechanisms, and analytical capacity taking into account the applicable EU GMP guidelines.
• The third country’s arrangements in order to ensure regular and rapid provision of information by the third country to the EU in relation to non-compliant producers of active substances.

On the 28 January 2026 the Commission published version 3 of their Q&A regarding the importation of APIs from outside of the EU and version 2 of the certification template. The changes are only minor, with just 3 changes to the Q&A and the addition of the inspection authority (if different from the issuing authority) to the template.