Italian Medicines Agency Agenzia Italiana del Farmaco

Import medicines in case of shortage

Import medicines in case of shortage

The evaluation of an import request is a complex procedure, given the many types of medicines involved, the continuous variation of therapeutic needs, the production and commercial criticalities, as well as the constant legislative evolution and the fragmentation of decision-making skills.

Below, AIFA provides important information for citizens, patient associations, and general practitioners, as well as for health professionals and pharmaceutical companies.

Import guidelines

AIFA, pursuant to Ministerial Decree of 11.05.2001, cannot issue authorizations for the import of analogue medicines, regularly registered abroad, on the basis of requests coming directly from private citizens, patient associations or doctors, but exclusively from health facilities (also through the regions) and by the Territorial Pharmacy Services (ASL) affiliated with the NHS.
The procedure to be activated for issuing the import authorization for a similar medicine marketed abroad is as follows:

  • The patient must go to the general practitioner/specialist, who will fill in the appropriate import request form available on the Agency website, on the "Shortages forms" page.
  • This form, together with the doctor's request and the therapeutic plan, where the latter is envisaged, must be delivered to the competent health facility for the area (ASL, hospital pharmacy, etc.), which will complete the request for the parts of its competence.
  • Finally, the health facility must send the form to the AIFA, to the certified e-mail address

It should be noted that AIFA's authorization for the import of medicines from abroad pursuant to DM 11/05/2001 and 12/04/2012 is limited to the following cases:

  • shortage of medicines authorized in Italy and their analogues, except for specific measures taken to protect public health and listed in the list of medicines not registered in Italy for which the AIFA has adopted specific measures;
  • vaccines and blood products.

The import of shortage medicines, included in the category of narcotic drugs and psychotropic substances, pursuant to Presidential Decree 309/1990 and subsequent amendments, falls within the competence of the Ministry of Health - Central Office of Narcotics.
For all other categories of medicine, including medicines not authorized in Italy, the import clearance is issued by the Maritime Air and Border Health Offices (USMAF) of the Ministry of Health.
The request form for medicines authorized in Italy and temporarily unavailable must be sent by certified mail to the certified email address:
Please note that the correct and understandable compilation of each section of this form does not represent a mere bureaucratic fulfillment, but an indispensable condition for the evaluation of the import request and that the lack of the fundamental information requested is one of the main causes of the time extension for the conclusion of the procedure.

Pharmaceutical companies have the possibility to apply for authorization to import a temporarily shortage medicine they own, with specific indications for blood products.
The information requested, contained in the instructions available in "Related documents", must be sent by certified mail to the certified email address:

Authorisations granted to MAH to import medicines temporarily subjected to shortage

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