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In brief

With Resolution No. 166 of 10 February 2021, the Italian Medicine Agency (AIFA) specified the criteria for inclusion in the transparency list of off-patent drugs that have the same composition in terms of active ingredients, as well as the same pharmaceutical form, administration route, mode of release, number of posological units and dose units.

In more detail

The criteria for inclusion in the transparency list, as defined in Annex 1 to the above-mentioned resolution, are based on the following principles:

  1. clarity, through the provision of clear and punctual definitions, both of a technical and regulatory nature
  2. transparency, by detailing the requirements necessary for the inclusion and exclusion of medicines in the transparency list
  3. universality, which provides for the inclusion within the list of all legal grounds for the purchase of medicines reimbursed by the NHS
  4. gradual inclusion, according to which new groupings relating to active ingredients previously not included in the list are progressively included, subject to the assessment by the AIFA’s Technical-Scientific Committee
  5. protection, which provides for the publication of guidelines about the unavailability or shortage of medicines; and (vi) dynamism, through the monthly updating of the list

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.


Riccardo Ovidi is an associate in Baker McKenzie's Rome office.