Italian Medicines Agency Agenzia Italiana del Farmaco

Procedure for the review and validation of lists of therapeutic indications for innovative medicines by pharmaceutical companies - Procedure for the review and validation of lists of therapeutic indications for innovative medicines by pharmaceutical companies

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Procedure for the review and validation of lists of therapeutic indications for innovative medicines by pharmaceutical companies

The list of medicines that were recognised as innovative in 2020 has been made available only for marketing authorisation holders of medicines with full or conditional innovativeness status.

For each product in the list, details are given on the therapeutic indications for which it is authorised and on whether such indications are innovative.

The above information is available on AIFA’s Front/End platform in the section entitled ‘Pharmaceutical expenditure payback for direct purchases in 2020’. This section is accessible by companies using the respective credentials, and comments can be submitted no later than 12 April at 6pm.

Marketing authorisation holders are therefore asked to check and, if necessary, correct/supplement the information contained in the files in accordance with the instructions laid down in the Annex entitled ‘Completion Instructions’.


Published on: 29 March 2021

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