On June 3rd 2014 a Decision dated April 14th 2014 by the Italian Medicine Agency (AIFA) entered into force, establishing the requirements for the application of the provisions regarding the stock disposal of the packs of medicinal products whose marketing authorizations were changed or renewed.
According to the new decision, the marketing authorization holders of medicines authorized for the Italian market have the obligation to make the updated patient information leaflet available to pharmacists within 30 days from the publication of the relevant decree in the Italian Official Gazette, so that pharmacists can in turn deliver it to the users.
For this aim it is possible to voluntarily provide Farmadati with an updated patient information leaflet. Farmadati is the information service provider that will manage the database available to pharmacies.
Di Renzo Regulatory Affairs is offering the following services to all companies intending to use Farmadati services to comply with the AIFA decision:
- preparation of the cover letter
- preparation of the documents to be sent to FarmaStampati
- preparation of the communication regarding the marketing of the first batch including the updated PIL
- relevant communication to Farmadati