The Technical Scientific Commission of the Italian Medicines Agency (AIFA), has authorized the use of two new antiviral drugs - molnupiravir and remdesivir - for the treatment of COVID-19, the regulator said on Thursday
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Evaluating the mechanism of action, efficacy, safety, storage temperature, dose units, vaccinal strategy, and alternative compounds for COVID-19 vaccines.
In brief
With Directorial Determination No. 357/2021, the Italian Medicines Agency (AIFA) adopted a new simplified procedure for negotiating the price and reimbursement of medicines placed on the market through parallel import procedure. Those intending to use the simplified procedure must send to the AIFA the dossier indicating the price proposal, reduced by at least 7% compared to the retail price of the corresponding product already marketed in Italy.
In particular, the new procedure establishes that, upon receipt the relevant application, the AIFA shall carry out an administrative check on the documentation transmitted and communicate to the applicant any further negotiating conditions required for the conclusion of the procedure. In case the importer accepts all the requested conditions, the proposal for eligibility to reimbursement is submitted to the approval of the AIFA’s Board of Directors, which is followed by the adoption of the relevant determination.