2027 Annual Fees – Marketing Authorization Holders
The signing of the contract with NMVO Italia is mandatory for all Marketing Authorization Holders (MAHs) active in the Italian market in order to govern the methods of contribution by the aforementioned Holders to the implementation and management costs of the National Medicines Verification System (NMVS), as established by Legislative Decree 10/2025.
Every year (the 'collection year'), typically in the month of September, NMVO Italia initiates the collection of annual fees for the following year.
The collection of annual fees for 2027 will be launched in November 2026. The payment deadline is 30 days following the issuance of the invoice.
It is specified that the signing of the contract with NMVO Italia differs from the one that companies enter into with EMVO (European Medicines Verification Organization), which is necessary for uploading serial numbers (the unique codes of medicinal product packs) to the central European system (EU Hub).
The new fee model for 2027 – Key principles
For 2027, the contribution model is being updated: transitioning from a flat fee, which was equal for all Marketing Authorization Holders (MAHs) and set for 2026 to account for the stabilization period, to a system proportional to RX revenue brackets generated in Italy during the fiscal year preceding the collection year.
Alignment with the European benchmark: The contribution structure for 2027 was defined in full compliance with the non-profit model and is aligned with the benchmark of the major European NMVOs (click here for the summary document on fees from other NMVOs: LINK)
Balanced distribution: The contribution is structured into progressive brackets based on the RX product revenue generated by the Marketing Authorization Holder (MAH) in Italy during the fiscal year preceding the collection year.
Cap per Corporate Group: the request for contribution is addressed to each individual Marketing Authorization Holder (MAH); should multiple MAHs belong to the same corporate group, the cumulative total of contributions will not exceed €100,000 per group.
Absence of discretion: Allocation to a bracket is determined automatically based on the RX revenue generated in Italy during the fiscal year preceding the collection year, self-certified by the Holder in the dedicated form or, in the absence of self-certification, inferred from public sources. Payment in installments is not permitted
Amount of the new 2027 annual fees
| Bracket | RX Revenue of the MAh generated in Italy during the fiscal year preceding the collection year | Annual Fee 2027 amount |
|---|---|---|
| 1 | From 1 to 1.5 billion EUR | 100.000,00 € |
| 2 | From 700 million to 1 billion EUR | 89.171,24 € |
| 3 | From 500 to 700 million EUR | 74.920,44 € |
| 4 | From 300 to 500 million EUR | 61.170,97 € |
| 5 | From 200 to 300 million EUR | 48.359,89 € |
| 6 | From 100 to 200 million EUR | 37.459,41 € |
| 7 | From 50 to 100 million EUR | 26.487,80 € |
| 8 | From 30 to 50 million EUR | 18.465,16 € |
| 9 | From 10 to 30 million EUR | 12.950,56 € |
| 10 | From 4 to 10 million EUR | 8.092,15 € |
| 11 | Less than 4 million EUR | 4.325,44 € |
Annual Fee 2027: Information and operational guidelines
To initiate the billing process for the 2027 Annual Fee, all Marketing Authorization Holders (MAH) will receive an "Amendment Letter for Article 4 of the Onboarding Agreement" via email.
Below are the main details and operational guidelines contained in the communication:
Legal validity and no signature required: The 'Amendment Letter' defines the new financial terms effective from January 1, 2027, and includes the new Annex 4 (revenue brackets and corresponding fee amounts). The letter, sent pursuant to Article 4.1.5 of the Onboarding Agreement, requires no signature or countersignature by the MAH and must not be returned to NMVO Italia.
Pro forma invoice verification: The document you will receive together with the "Amendment Letter" is a pro forma invoice. We kindly request administrative contacts to verify the corporate details, VAT number, and indicated amounts. Please notify us promptly at the email address onboarding@nmvo-italia.it of any:
Any PO (Purchase Order) number or administrative references to be included on the invoice.
For Italian MAHs only: confirmation of the Codice Destinatario (SDI) for electronic invoicing.
Upon completion of this process, the final invoice will be sent to you.
Payment and invoicing terms: Payment is due within 30 days in accordance with the contractual terms, via bank transfer to the bank details provided in the "Amendment Letter"
Confirmation of Corporate Group structure: Should the fee cover multiple companies belonging to the same group, please confirm within 15 days of receiving the email whether all linked entities remain active MAHs or if additional companies need to be included or excluded.
Updating NMVO Italia company details and bank information: Please remember to update your vendor master data with the new official details of NMVO Italia, avoiding the use of details from previous payments:
New Registered / Operational Office: Via del Tritone 169 – 00187 Rome, Italy
New bank details: please use exclusively the IBAN and SWIFT code provided in the received Amendment Letter.
Status of the Onboarding Agreement: Should your company have not yet completed the signing and submission of the Onboarding Agreement to NMVO Italia, please regularize your position as soon as possible to ensure operational continuity within the medicines verification system.
