The Italian Medicines Agency, following what was anticipated in the press release of 19 May, informs that more features of the Price and Reimbursement e-Dossier web platform have been released today.
The platform is available for pharmaceutical companies on the AIFA Services Portal, for drafting dossiers in digital format to support requests for price and reimbursement, pursuant to the provisions of Ministerial Decree of 2 August 2019 "Criteria and methods by which the Italian Medicines Agency determines, through negotiation, the prices of drugs reimbursed by the National Health Service "(GU no. 185 of 24 July 2020) and the subsequent Guidelines published on 30 December 2020, adopted with AIFA Resolution no. 1372 of 23 December 2020.
The new features implemented are described below:
- request for recognition of innovation: the request for recognition of the innovation requirement has been integrated into the price and reimbursement dossier.
- compilation of the Dossier relating to simplified procedures (Negotiation Type - TN.8) referred to in the AIFA Notice of 20 April 2021, listed below:
- TN 8.1. Biosimilar medicine with application to comply with Ministerial Decree of 4 April 2013;
- TN 8.2. Equivalent medicine with application to comply with Ministerial Decree of 4 April 2013 "Criteria for identifying the brackets for automatic negotiation of generic and biosimilar medicinal products";
- TN 8.3. Parallel import medicines with request to comply with the simplified procedure (AIFA Resolution no. 357/2021);
- TN8.4. Packages in class C (NN) with a request for classification in class C (in case of classification in class C of all the other packages already authorised of the same medicine);
- the Dossier Filing Date function: it allows to change the status of the dossier from Completed to Filed by entering the sending date of the price and reimbursement request. Pending the release of the new Price and Reimbursement portal and its integration with the e-Dossier platform, the filing date is collected for information purposes only and has no legal value, with respect to the actual filing of the dossier.
Additional features, such as the printing of the draft dossier, the additions and updates of the dossier in the endo-procedural phase, the automatic compilation by sections of the dossier with overlapping data and the profiling of supplier users will be implemented with further releases.
Finally, it is recalled that until 30 November, the end date of the 6-month transition phase, it will be possible to fill in the Dossier also with writing tools alternative to the new e-dossier Portal, and to send it in .pdf and word format, in compliance with the provisions of the Guidelines published on 30 December 2020 and adopted with AIFA Resolution no. 1372 of 23 December 2020.
In both cases, the Dossier shall be filed, together with the already envisaged additional supporting documentation for the request (e.g. cover letter, SmPC, etc.), through the current online negotiation system, giving appropriate communication by certified email (PEC) to the HTA Division at email@example.com, also copying firstname.lastname@example.org. In any case, from 31 May 2021 paper dossiers are no longer accepted.
Published on: 09 November 2021