9th February 2025 is the deadline for full implementation of the EU Falsified Medicines legislation (Directive 2011/62/EU and EU Delegated Regulation 2016/161) at a national level in Italy. The law outlining the steps towards the Italian national implementation of the EU legislation, which included the establishment of a national Italian NMVO, was published in the Official Gazette on 21st February 2024: Italian Transition to EU Falsified Medicines Directive Compliance – Acorn Regulatory
Under Article 31 of EU Delegated Regulation 2016/161, the costs of setting up the National Medicines Verification System in each EU member state are borne by the manufacturers of the medicines required to carry safety features.
To this end, Industry was informed at a recent Italian Farmaindustria meeting that the Italian NMVO has begun issuing requests for payment, which it terms an NMVO “entrance fee” to all MAHs operating in the Italian market. Following an international benchmarking exercise with other NMVOs, NMVO Italia has set the “entrance fee” at €5,000 plus VAT for each MAH. Pro-forma invoices will issue to MAHs and payment must be made within 30 days of receipt of invoice.
