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European Commission - Press release

Pharmaceuticals: Commission calls on Italy to comply with EU rules on marketing authorisation of generic drugs

BRUSSELS, 26 January 2012 – Today the European Commission has formally requested Italy to comply with EU legislation concerning the marketing authorisation procedures of generic drugs.

According to Directive 2001/83/EC on the Community code for medicinal products for human use, the processing of marketing authorisation procedures can be carried out without being affected by the protection of industrial and commercial property interests. On the other hand, the authorisation holder of a generic drug is not allowed to place a product on the market before the patent on the reference product has expired.

. In Italy, a law prevents manufacturers of generic products to submit their request for marketing authorisation prior to the penultimate year of the lifetime of a patent on a reference product. For example, if a patent on a reference product has a 10 year lifetime; manufacturers will need to wait at least 9 years before they are allowed to submit their request for marketing authorisation. As a result of this law, and of the lengthy procedure to secure the authorisation for marketing, manufacturers of generic products are placed at a disadvantage on the market.

Therefore, the Commission asks Italy to ensure full compliance with European law. Today's request takes the form of a "Reasoned Opinion" under EU infringement proceedings. If Italy does not comply with the "Reasoned Opinion" within two months, the Commission may decide to refer the case to the European Court of Justice.

For more information:

The infringement procedure: MEMO/12/42

The marketing authorisation procedures of medicinal products for human use:

Link to the Directive 2001/83/EC of the European Parliament and of the Council (consolidated version of 05/10/2009):

Contacts :

Frédéric Vincent (+32 2 298 71 66)

Aikaterini Apostola (+32 2 298 76 24)

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