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The 2011/62/EU Directive

The 2011/62/EU Directive amending 2001/83/EC Directive, introduces relevant innovations in the pharmaceutical sector.

Among the provisions are:

  • the intensification of controls on the supply chain;
  • the coordination between Member States in planning inspections on manufacturers and distributors of medicines and active ingredients (in EU and non EU Member States);
  • the strengthening of the national anti-counterfeiting system and of the cooperation with customs (with a focus on checks on suspect goods in transit) and the regulation of the sale of medicines through the Internet.

Regarding this last point, all Member States, when implementing EU regulation, will be required to regulate the sale at a distance of medicinal products to the public by means of information society services (as defined in Directive 98/34/EC). The natural or legal person offering the medicinal products should be authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established. The natural or legal person must notify information to the national competent authority (name or corporate name, permanent address, website).

The use of a common logo, nationally customized and recognisable throughout the Union, will allow to distinguish between legal websites and not authorized websites. Each Member State shall set up a website providing information about national legislation and the list of authorised websites offering medicinal products for sale at a distance.