In brief
On 23 December 2021, the AIFA published a note providing clarifications on the renewal procedures for parallel import licenses of medicinal products (“AIP”). In this respect, the note clarifies that AIP holders must submit to the AIFA a renewal application for each authorized package at least nine months before the expiry of the validity of the relevant AIP, whose duration is five years from the date of publication in the Official Journal of the granting decree.
Where the holder does not intend to renew the AIP, it must promptly notify the AIFA’s Certifications and Parallel Imports Office and submit an application for withdrawal to the AIFA’s Product Quality and Fight against Pharmaceutical Crime Office.
In case the renewal application is not filed within the prescribed timeline, the relevant AIP shall be considered expired at the end of the fifth year from the date of publication of the granting decree pursuant to Article 38 of Legislative Decree No. 219/2006. In such a case, the AIP holder shall have a period of 90 days for the marketing of the relevant stocks, provided that the reference medicinal product on which the AIP is based is duly authorized at the time of the forfeiture.
