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Italian Medicines Agency Agenzia Italiana del Farmaco

Medicines currently lacking

Medicines currently lacking

AIFA constantly updates and publishes a List of temporarily shortage medicines on this page of the institutional portal, which includes the following information:

  • the shortage medicine's trade name, active ingredient, pharmaceutical form, packaging, and the name of the company holding the MA;
  • date of commencement and presumed termination of the shortage;
  • existence or nonexistence of equivalents;
  • reasons that led to the shortage;
  • suggestions and/or measures adopted by the AIFA;
  • any possible notes.

The information provided by MA holders and reports received and validated by the office are used to update the list.

In addition, an extract of the list of temporarily unavailable medicines is published, for which the AIFA issues import authorization to health facilities for similar ones authorized abroad or has given an Import Determination to the MA holder.

The AIFA also publishes the list of decisions with which the companies holding the MA for shortage medicines have been authorized to import similar medicines from other countries.

Finally, AIFA publishes the list of medicines that cannot be removed from distribution and sale, in order to ensure a supply of medicines sufficient to meet the needs of treatment throughout the country.

The temporary block of exports of medicines may be ordered by AIFA in the event that it is necessary to prevent or limit states of shortage or unavailability, according to the provisions of art. 1, paragraph 1, letter s) of Legislative Decree no. 219/2006 concerning the "Implementation of Directive 2001/83/EC (and subsequent amending directives) on the Community code relating to medicinal products for human use" and subsequent amendments and additions.

List of medicinal products which may not be withdrawn from distribution and sale for national territory in order to prevent or limit shortages or unavailability

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