Legislation

In compliance with Article 12 of Legislative Decree 33/2013, as amended by Legislative Decree 97/2016, this section contains a non-exhaustive selection, for consultative purposes, of the most relevant legislation and regulations relating to the Italian Medicines Agency.

It should be noted that:

  • In the case of national legislation, the Normattiva portal provides the most complete version of the deed, including any updates occurred over time. Should you need to view the deed as it is in force on the date of consultation, just click on "printable version" and then on "view". For further information, please refer to the user guide of the Normattiva portal.
  • In the case of EU legislation, the Eur-lex portal was queried with reference to the latest consolidated version (updated), where available; it is however advisable to check that no other updates have occurred at the time of consultation. For further information, please refer to the Eur-Lex Guide.
  • For the remaining types of sources (Ministerial decrees, etc.) the update date is shown in the epigraph; however, it is recommended checking with the competent Administration that no other updates have occurred at the time of consultation.