After almost a year of waiting, the new Decree from the Italian Ministry of Health and the Ministry of Economy and Finance relevant to the negotiation of price and reimbursement of medicinal products (Decree 2nd August 2019) was published in the Italian Official Journal on 24th July 2020.
We talked about this new decree and the introduced changes in a previous article here.
A guideline with the practical indications on the preparation and requirements for the Pricing and Reimbursement applications is now expected from the Italian Medicines Agency (AIFA) within the following 30 days.
A new article will be released by Regulatory Pharma Net as soon as any updates become available. Stay tuned!
Regulatory Pharma Net is available to support pharmaceutical companies with strategic analysis and advice, development and submission of the Pricing and Reimbursement application, follow-up of the procedure and attendance to negotiation meetings with the Authority.