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Concept paper on Delegated Act on Shipments of Medicinal Products through EU - 26 Sep 2012

The European Commission has published a draft Delegated Act concerning a new requirement of the Falsified Medicines Directive under which medicinal products are shipped through the European Union.  The concept paper entitled "Delegated Act on the Criteria to be considered and the Verifications to be made when assessing the potential falsified Character of Medicinal Products introduced in the Union but not intended to be placed on the Market" has been published for Public consultation until 10 December 2012. The adoption of the delegated act is tentatively scheduled for 2013.

In effect the delegated Act stipulates that Medicinal Products should be checked for their identity, source and/or history. Furthermore, analytical testing as well as verifications of the packaging and of the labelling should also be considered as part of the checks. The concept paper highlights some practical challenges, for example where there is a possible lack of reference samples or where the original packaging is unknown, but does not provide practical suggestions or guidance on how to address the matter.

The checks and/ or verifications as stipulated in the text may only be carried out by different authorities in the EU Member States and not by the company involved in the supply chain of the product under scrutiny.

The concept paper can be downloaded here.

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