AIFA. Public consultation on the list of drugs dangerous for driving

Public consultation on the list of dangerous drugs for driving pursuant to art. 55 of law 120/2010

L’Agenzia Italiana del Farmaco (AIFA) ha deciso di aprire una consultazione pubblica, ai sensi della legge 241/90 e s.m.i,  sul documento allegato, recante la lista dei farmaci pericolosi per la guida e classificati secondo i criteri stabiliti dal progetto integrato della 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.

Con questa iniziativa di consultazione, l’AIFA si propone di raccogliere i commenti e le proposte dei titolari 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. Avviso alle Aziende – 23/01/2017

 

 

 

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