Marketing Authorisation Holders are informed that the Italian Official Journal, General Series No 178 of 27 July 2021 includes AIFA Decision DG No 880/2021 of 19 July 2021 amending AIFA Decision No 204 of 25 August 2011 implementing Article 35, paragraph 1a, 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 on the ‘tacit agreement’ procedure for type I variations.

Specifically, AIFA Decision DG/880/2021 extends the scope of the tacit agreement procedure to variations involving changes to the Product Information (PI) concerning safety and efficacy (group C) pursuant to the guidelines on the details of the various categories of variations, on the operations of procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008. This applies to variations submitted in accordance with the mutual recognition procedure, both when Italy acts as the Reference Member State (IT-RMS) and when it acts as a Concerned Member State (IT-CMS), also under grouping or worksharing procedures, which have already been successfully concluded at European level and when the Reference Member State (RMS) has approved the ‘common’ PI.

Marketing Authorisation Holders are required to publish the type I variations falling within the scope of the ‘tacit agreement’ procedure referred to in the abovementioned Decision, in the Italian Official Journal, Part Two, within 45 days from the exipry of the periods referred to in Regulation (EC) No 1234/2008, as amended. For that purpose, in accordance with the provisions of AIFA Decision No 821/2018 of 5 July 2018, the forms annexed to the communication on the updating of forms for type I variations falling within AIFA Decision No 821 of 24 May 2018 must be used (see AIFA communication dated 5 July 2018).

The PDF file attesting publication in the Official Journal and the Product Information (SmPC, PL and/or Labelling) must be sent to AIFA’s Post Authorisation Procedures Office, within 30 days from the date in which the variation has been published in the Italian Official Journal, by uploading all material to the Variations Portal. The Product Information must be submitted as a Word document, without any atwork, and with edits to the authorised text in track changes, as a supplement to the variation.

As of the effective date of Decision DG/880/2021 of 19 July 2021, all applications for variations falling within the scope of the abovementioned Decision will be subject to the ‘tacit agreement’ procedure, even if they have been submitted to AIFA before that date, provided that the deadlines laid down in Regulation (EC) No 1234/2008 and as amended have expired.

In order to provide further clarifications, an explanatory note will be published.