Serialization Italy – AIFA resolution on the procedures for granting Marketing Authorisations (AIC) and on the modalities for fulfilling the obligations set out in Article 4 of Legislative Decree No. 10 of 6 February 2025, including those relating to imported and parallel-distributed medicines
The resolution containing the "Application Instructions" regarding the regulatory obligations for holders and applicants of Marketing Authorizations (AIC) or Parallel Import Authorizations (AIP) has been published on the AIFA website.
Link to AIFA website
The text of the application instructions is attached (in Italian).
