Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use lays down the rules for inter alia manufacturing, importing, placing on the market, and the wholesale distribution of medicinal products in the Union as well as rules relating to active substances.

There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source. Those products usually contain sub-standard or falsified ingredients, or no ingredients or ingredients in the wrong dosage, including active substancesthus posing an important threat to public health.

Past experience shows that such medicinal products do not reach patients only through illegal means, but via the legal supply chain as well. This poses a particular threat to human health and may lead to a lack of trust of the patient alsoin the legal supply chain.Directive 2001/83/EC should be amended in order to respond to this increasing threat.

A copy of the provisional edition of the Directive can be downloaded here:

ATTACHMENTS (Click on the filename to download):

EU Directive on Falsified Medicines