Last Friday, the Italian Medicines Agency (AIFA) published a warning to marketing authorisation (MA) holders concerning the imminent invalidity of certain MAs in application of the ‘sunset clause’ (Warning).
Article 38 of the Italian Medicines Code, implementing Article 24 of the EU Medicines Directive in Italy, provides that an MA ceases to be valid if the medicinal product concerned (i) is not placed on the Italian market within three years of the MA grant or, when the product was previously placed on the Italian market, (ii) it is not actually present on the market for a period of three consecutive years (so-called sunset clause).
AIFA has drawn up the list of MAs based on sales data provided by the Medicines Traceability System of the Italian Ministry of Health. The list identifies approximately 100 products which MA is due to become invalid between 31 July and 1 October 2017 in application of the sunset clause.
Concerned companies have 30 days from the publication of the Warning (i.e., until 23 July 2017) to take any of the following actions:
- Notify AIFA (email@example.com) of any inaccuracy in the invalidity dates indicated in the Warning in relation to their products, by submitting a copy of the Italian Official Journal where details of the MA grant were published;
- Place the relevant product(s) on the market in order to avoid application of the sunset clause;
- Seek an exemption, on the basis of documented justifications (e.g., necessary/emergency products, export-only medicines, IP reasons, bankruptcy, etc.), in accordance with AIFA’s guidelines on the ‘sunset clause’.
Absent any reaction by MA holders, and subject to confirmation of the sales data in the Medicines Traceability System, the identified MAs will cease to be valid as of the dates indicated in the Warning. Notice of such invalidity will be published in the Italian Official Journal.