The Italian Official Journal, General Series, No 178 of 27 July 2021 contains AIFA Decision DG No 880/2021 of 19 July 2021 amending AIFA Decision No 204 of 25 August 2011 implementing “Article 35, paragraph 1-bis, of Legislative Decree No 219 of 24 April 2006 on the marketing of medicinal products”, as supplemented by AIFA Decision No DG/512/2019 of 12 March 2019, relating to the “tacit agreement” procedure for type I variations.
 
Specifically, the above-mentioned AIFA Decision extends the scope of the “tacit agreement” procedure to type I variations that involve the amendment of the product information (PI) and concern safety and efficacy (Group C) as per the Guidelines on the details of the various categories of variations. This applies to variations submitted in accordance with the Mutual Recognition Procedure, both when Italy acts as Reference Member State (IT-RMS) and as a Concerned Member State (IT-CMS), that have been submitted also as a grouping or worksharing, and that have already been successfully concluded at European level, where the Reference Member State (RMS) has approved the ‘common’ PI.

It should be noted that, if the terms of Regulation (EC) No 1234/2008 as amended have expired and variations fall within the above cases, Marketing Authorisation Holders are required to publish the variation in the Italian Official Journal, Part Two, in accordance with the provisions of the “Explanatory note on the application of the ‘tacit agreement’ procedure, in line with the provisions of AIFA Decision DG/880/2021 of 19 July 2021”. In the absence of such publication, the national phase of the variation approval shall not be deemed to have been completed.

This is without prejudice to any subsequent self-protection measure that this Agency may take if the conditions are met, in accordance with the combined provisions of Articles 20(3) and 21h of Law No 241/1990, as amended.