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The transposition of Directive 2011/62/UE in Italy

The transposition of directive 2011/62/EU in Italy, implemented with the legislative decree no. 17 of 19 February 2014, introduces measures to prevent and fight the spread of falsified medicinal products for human use. These measures are:

  • a new and complete definition of falsified medicinal product
  • the introduction of a new figure - the broker - who is the medicinal products trading intermediary who acts on behalf of another natural or legal person
  • the definition of safety features
  • the reinforcement of the Good manufacturing and distribution practices
  • the reinforcement of the inspections’ coordination among the European Union (EU) Member States
  • the consolidation of the inspections on the medicinal products in transit through the reinforcement of the cooperation among health authorities and customs
  • the regulation of the sale of medicinal products at a distance to the public

This very last point is the most innovative aspect with respect to the national legislation.
The purpose of the European legislator, with respect to the online sale of medicinal products for human use, is to harmonize the European framework: for some time now, in certain countries (such as the United Kingdom), the online trade of medicinal products is legal, whereas in other countries (in Italy, for example) this type of e-commerce was not allowed yet.
The Italian authorities are finalising the procedure that, in the short term, will allow natural or legal persons to sell medicinal products at a distance to the public also in Italy, provided they have already been granted the authorization to distribute medicinal products to the public.

What difference does it make for Italian citizens?
Italian citizens will be able to buy medicinal products not subject to medical prescription through both Italian and European legal websites.
In Italy the possibility to purchase medicinal products at a distance is limited to medicines not subject to medical prescription. Since retailers are obliged to respect the laws of the country of destination of the medicinal products, in case an Italian citizen buys a medicine from a legal foreign website, the retailer will not be able to send medicinal products subject to medical prescription, because the Italian laws forbid to do it.

How can you recognize authorized websites?
A legal website must display the common logo on each webpage.

What are the inspections carried out in order to fight the trade of medicinal products that are falsified and dangerous to health?
The Italian authority (Agenzia Italiana del Farmaco – AIFA), in accordance with the transposition of the European directive, has set up a Conference of stakeholders (Conferenza dei servizi), with the task of:

  • examining the cases reported or identified by the surveillance activity conducted in agreement with the Italian enforcement police (Comando dei Carabinieri per la tutela della salute – Nas)
  • identifying the infringements to the e-commerce law concerning the sale of medicinal products to the public

The Conference of stakeholders is composed of AIFA, Ministry of Health, Ministry of Economic Development and Carabinieri Nas and, as observers, the Italian Competition Authority (Autorità garante della concorrenza e del mercato) and the National Research Council (Consiglio nazionale delle ricerche - Registro.it).
Upon receipt of warnings on a website suspected to illegally sale medicinal products at a distance to the public, the Conference carries out inspections and, in case of ascertained violation of current legislation, the Ministry of Health, on AIFA’s proposal, orders to cease the illegal trading practice on the base of a substantiated decision. The decision is enforced by Carabinieri Nas and any failure to comply with it is subject to a fine from 20,000 to 250,000 euros.

How to report illegal websites?
Everybody (authorities, associations and private citizens) can report suspected websites.
You can, firstly, check an e-pharmacy by the Fakeshare’s search module of illegal e-pharmacies. If a web address is not in the database, we invite you to report the suspected e-pharmacy using the form that will be soon provided in the Project’s website.

Further information on the legislation:
directive 2011/62/EU
Italian legislative decree no. 17 of 19 February 2014
Italian legislative decree no. 219 of 24 April 2006