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Not transposing FMD could land Ireland, Italy, Poland and Slovenia in court says EC

By Gareth MacDonald+

19-Feb-2014
Last updated on 11-Aug-2014 at 12:57 GMT

The European Commission (EC) has increased the pressure on Ireland, Italy, Poland and Slovenia to fall into line with other EU member States and introduce anti-drug counterfeiting legislation.

When the European Union (EU) formally adopted the Falsified Medicines Directive (FMD) in 2011 it gave member states until January 2, 2013 to transpose and apply the anti-counterfeiting legislation contined in the Directive.

While the majority of EU countries comfortably met the deadline, four member states - Ireland, Italy, Poland and Slovenia –  have still not transposed the FMD according to a European Commission spokeswoman, who told in-Pharmatechnologist.com this failure could “lead to the Commission referring the cases to the Court of Justice of the European Union.”

The comment comes just a week after the Commission revealed - in the minutes of the most recent meeting of its Pharmaceutical Committee – that it has initiated the “third and final stage of the infringement procedure against the Member States that still have not notified the transposing national laws.”

State of play

In the minutes the Commission also provided a wider update on implementation of the FMD.

It highlighted “progress on the delegated act for good manufacturing practice) for active substances, the implementing act on the logo for on-line pharmacies and guidelines on good distribution practice (GDP) for active substances, which are expected to be adopted in Q1 2014.”

Representatives from the European Medicines Agency (EMA) who also attended the meeting highlighted upgrades made to the EudraGMP database – which now includes GDP data – as indication of progress made by the agency.

API imports, no shortages

The Commission also reported that new import requirements on active pharmaceutical ingredients (APIs) shipped to Europe that were introduced on July 2 , 2013 have not had a negative impact on European drugmakers or caused the shortages that some had predicted.

EMA and the HMA Taskforce on the Falsified Medicines Directive have monitored the implementation of the rules during the summer and no shortages, disruption of trade or other critical situations were reported.

Most active substance manufacturers exporting to the EU are now covered by a written confirmation,” the Commission added, going on to say that it is now following up with third countries on GMP non-compliance of sites covered by written confirmation.

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