Public consultation on the list of dangerous drugs for driving pursuant to art. 55 of law 120/2010
The Italian Medicines Agency (AIFA) has decided to open a public consultation, pursuant to law 241/90 and subsequent amendments, on the attached document, containing the list of dangerous drugs for driving and classified according to the criteria established by the integrated project of the European Commission DRUID (Driving under the Influence of Drugs, Alcohol and Medicines) (attachment 1). This document will be incorporated as a technical attachment to a Ministerial Decree to be issued by the Ministry of Health. The explanation of the risk categories is given in attachment 2.
With this consultation initiative, AIFA intends to collect the comments and proposals of the owners AIC in order to draw up a list as exhaustive and updated as possible of the principles active ingredients that may affect the ability to drive and operate machinery.
All holders of medicinal products that contain warnings on the ability to drive and operate machinery in the printouts, and which are not included in the attached list, are invited to notify them to the following email address farmacovigilanza@aifa.gov.it, together with a classification proposal using the same format as the attached list.
Likewise, proposals for justified modifications of the classification of substances already included in the attached list may be sent, always to the same email address, using the same format.
The public consultation will end on the ninetieth day from the date of publication on the AIFA web portal.
AIFA. Notice to Companies – 23/01/2017