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Farmastampati and stock disposal

As of 3 June 2014, Decree 14 April 2014 of the Italian Medicine Agency is in force. This has established the requirements for the application of the provisions regarding the stock disposal of packs of medicinal products whose marketing authorisation (MA) has changed affecting the product information. The a.m. AIFA decree was then integrated and updated by the AIFA Decree no. 821 of 24 May 2018, in force as of 11 July 2018.

Based on this Decree, MA holders of medicinal products marketed in the Italian territory have the obligation to deliver the updated package information leaflet and labelling to pharmacists within 30 days form the publication of the relevant variation in the Official Journal, to enable pharmacists to deliver updated materials to users.

The delivery of the package information leaflet and/or labelling by pharmacists to patients can occur either by paper delivery or by using alternative information systems. To this purpose, it is required that the updated package information leaflet is supplied in electronic format to the database Farmadati or to other databases available at the pharmacies.

Thanks to the availability of many regulatory experts, Di Renzo Regulatory Affairs can assist companies in all the activities required to comply with the requirements of the AIFA decree. In particular, the following activities will be carried out:

  • Preparation of the documents to be sent to “Farmastampati” or to other databases
  • Drafting of the relevant cover letter
  • Preparation of the communication about the marketing of the first batch including the updated package information leaflet
  • Sending the relevant communication to “Farmadati” or to other databases.

Foto di stevepb da Pixabay