On 18 December 2025, Law No 182 of 2 December 2025, the ‘Simplification Law’, published in the Official Gazette, General Series No 281 of 3 December 2025, laying down ‘Provisions for the simplification and digitisation of procedures relating to economic activities and services for the benefit of citizens and businesses’, entered into force. 

Chapter II (Articles 58 to 63) contains Simplification measures in health matters. In particular, Article 61 ‘Provisions to combat shortages of medicinal products’ provides as follows:

1. Legislative Decree No 219 of 24 April 2006 is amended as follows: 
    a) in Article 34, paragraph 6 is replaced by the following: 
   «6. In the event of a temporary or permanent discontinuation of the marketing of a package of the medicinal product in the national territory, the MAH shall notify AIFA thereof. Such notification shall be made at least two months before the discontinuation of the marketing of the product, including in the event of a proven health emergency, and shall be renewed in the event of an extension of the period of discontinuation previously notified, except in the case of discontinuation due to unpredictable circumstances. The time limit does not apply to suspensions of marketing related to product safety reasons. The MA holder, even if the reasons for the interruption are exclusively commercial, shall inform AIFA of the reasons for such action, in accordance with the provisions referred to in paragraph 7»;

  b) in Article 148: 
1. in the first sentence of paragraph 1, the words: «paragraphs 6 and» are replaced by: «paragraph»; 
2. the following shall be inserted after paragraph 1: 
  «1-bis. In case of violation of the provisions of article 34, paragraph 6, regarding packages present in a special list published and periodically updated by AIFA, containing the medicinal products for which specific measures have been adopted to prevent or limit shortage or unavailability, even temporary, on the market or in the absence of valid therapeutic alternatives, the MAH is subject to the administrative penalty from six thousand euros to thirty-six thousand euros.
AIFA, in agreement with the health authorities and trade associations in the pharmaceutical and patient sectors, shall identify the criteria for the inclusion of the packaging of medicinal products in the list referred to in the previous period and for its periodic updating, at least annually».