Parliamentary plenary on falsified meds set back to October

Phil Taylor

03-Jul-2010

EU logo and pills The deadline for the European Parliament’s vote on the draft Directive on Falsified Medicines has been set back from July and is now scheduled for October.

The latest update on the European Parliament's website now gives a date of October 6 for the European Parliament plenary sitting, which will review and perhaps vote on the amended version of the Directive first proposed by the European Commission in December 2008.

That would set the earliest possible date for potential political agreement on the amended text by the Council of the EU no earlier than December 6.

Under the EU legislative process the European Parliament and Council have to reach agreement on an identical final text before the proposal can become law. If no agreement is reached the proposal goes to a second reading in each institution.

The EC proposal included a number of measures to help secure the pharmaceutical supply chain in Europe from counterfeits, including new obligations for non-wholesaler medicines distributors, obligatory safety features such as serial numbers and improved seals, strengthened regulations governing inspections and imports of active pharmaceutical ingredients (APIs).

Amendments proposed by the Parliament have included widening its scope to cover Internet sales of medicines and inactive ingredients (excipients), tougher sanctions for offenders and measure to block the export of falsified medicines. The amendments also propose new definitions for falsified medicines, APIs and excipients.

The Council's Working Party on Pharmaceuticals and Medical Devices has covered similar ground, with amendments including new obligations for manufacturers to verify their suppliers comply with quality standards and establishing the list of exporting third countries whose regulatory frameworks for API ensure a level of protection of public health equivalent to that in the EU.

The Council amendments also call for a transitional period of six years for member states that already have a system for safety features in place, according to the latest June 3 document available here.

Related articles:

ENVI committee backs Matias report on falsified meds

Dalli vows to move quickly on medicines counterfeiting

Parliamentary report broadens, accelerates counterfeiting directive

Public health sector weighs in on EU proposals

'Devil is in the detail' of EC pharma package

Enjoyed this article? Subscribe to our weekly newsletter here.

Features
Papers & Media
Research
Events

EC seeks comment on unique medicine identifiers
The European Commission has published a concept paper on the unique identifier for medicines, outlined in the EU falsified medicines directive and due to be fleshed out via the delegated acts process.
WHO working group drafts resolution on SSFFC medicines
Last week's meeting of a WHO working group on low quality and illegal drugs ended with a draft resolution for debate at the next World Health Assembly.
FDA finalises guidance for on-dose anti-counterfeit technologies
The US FDA has published its final guidance on the use of on-dose anti-counterfeiting technologies - referred to as physicochemical identifiers or PCIDs - for use in solid oral dosage forms such as tablets and capsules.
Pangea IV nets illegal medicines worth around $6.3m
The latest Interpol-backed offensive against illegal medicines has led to 55 arrests and seizures of 2.4m potentially harmful drugs worth around $6.3m.
FDA report models counterfeiting and diversion patterns in US
A new report form the US Food and Drug Administration (FDA) has used historical cases of medicine counterfeiting and diversion to gain a better understanding of the methods used by criminals and help prevent incidents in future.