Italy: Project for addition of driving information on medicinal products packaging – Public consultation

The Italian National Competent Authority, AIFA, opened a public consultation on 23rd January 2017 in relation to a list of active substances capable of affecting the ability to drive and use machinery.

The list was established during the European commission Project DRUID (Driving under the Influence of Drugs, Alcohol and Medicine). Italy plans to include this list to a Ministerial decree and amend the requirements on medicinal products packaging.
Medicines are classified into 4 categories:

  • Category 0: none or negligible influence on the ability to drive (no warning necessary)
  • Category 1: Minimal influence on the ability to drive (level 1 warning: Be Careful! Read the patient information leaflet before driving)
  • Category 2: Moderate influence on the ability to drive (level 2 warning: Be very Careful! Don’t drive without the advice of your GP or pharmacist)
  • Category 3: High influence on the ability to drive (level 3 warning: Attention: danger! Do not drive. Seek medical advice before driving again)

New pictograms for categories 1, 2 and 3 will need to be displayed on medicinal products packaging.

AIFA would like to collect comments and suggestions from Marketing Authorisation Holders (MAH) on the proposed list of medicines. Similarly, MAH that report warnings on the ability to drive and use machine in their SmPC and PIL and are not included in the list are invited to communicate this information to AIFA together with a proposed classification.
All comments can be send to before the end of April 2017.

A similar approach with 3-level pictograms is mandatory for medicinal products marketed in France since 2009.

You can consult the original post, proposed list of medicine and pictograms here.