Onboarding of Marketing Authorization Holders (MAHs) in NMVO Italia
The onboarding in NMVO Italia is mandatory for all Marketing Authorization Holders (MAHs) and is required to support the costs of implementing and managing the National Medicines Verification System (NMVS), which is currently underway.
An initial “Entrance Fee” has been requested, as specified in the cover letter sent to MAHs, to finance the initial setup of systems and infrastructure by NMVO Italia.
Starting from September 1st 2025 the collection process will begin. Payment will be due within 30 days from the invoice issuance, which is expected around September/October.
Please note that the onboarding with NMVO Italia is different from the onboarding that the Marketing Authorization Holders have to perform with EMVO (European Medicines Verification Organization), which focuses on uploading serial numbers (the unique codes on medicine packages) into the central European system (EU Hub). The onboarding with NMVO Italia is necessary for managing the unique codes uploaded to the EU Hub within the national National Medicines Verification System (NMVS).
Reference Legislation
Onboarding is governed byArticle 31, paragraph 5 of Delegated Regulation 2016/161/EU, which establishes that the costs of the National Repository and NMVO Italia are to be borne by manufacturers of medicines with safety features, in accordance with Article 54-bis, paragraph 2, letter (e) of Directive 2001/83/EC.
Who Must Onboard?
The onboarding is mandatory for all Marketing Authorization (MA) holders in the Italian market who are authorised to market prescription‑only medicinal products.
Even MAHs (Marketing Authorisation Holders) that only market OTC/SOP products will be required to complete the onboarding process with NMVO Italia. In this case, they will be required to pay a one-time Entrance Fee (not the Annual Fee).
NMVO Italia Fee Model
Entrance Fee
Annual Fee
Onboarding process for Marketing Authorization Holders (MAHs) in NMVO Italia
To be properly onboarded in NMVO Italia, MAHs must follow these steps:
- Submission of Registration Data
- The first step is to submit the required company data for registration. Data should be sent to onboarding@nmvo-italia.it (or via the online form available at the bottom of the page). This allows NMVO Italia to register the company profile.
- Receipt of Proforma Invoice
- Once the company is registered, the MAH will receive a proforma invoice including the Entrance Fee amount to be paid. Payment of the Entrance Fee is required to proceed with the next onboarding phase.
- Submission of Onboarding Contract
- After payment confirmation, NMVO Italia will issue the final invoice for the Entrance Fee and send a template of the onboarding contract for managing each MAH’s data within the NMVS system. The contract will be sent in English to each MAH for signature and is non-negotiable. It is essential to sign the contract within the given timeframe to complete the onboarding procedure.
- Signatures and Completion
- Once the contract is signed by the MAH, the onboarding process is considered complete. After receiving the signed contract, NMVO Italia will request the Annual Fees, which must be paid within 30 days of the invoice date.
Following these steps, the company will be officially integrated into the NMVS system and able to manage medicine verification in compliance with European regulations.
Annual Fees Determination for 2026
For 2026, NMVO Italia’s Board of Directors has set the annual fee at €10,000 (excluding VAT) per individual MAH.
The annual fee must be paid during the 2025 calendar year after signing the onboarding contract, and no later than 30 days after receiving the invoice.
How to onboard?
- Registration – Fill out the onboarding request form on the official NMVO Italia website or send an email to onboarding@nmvo-italia.it including the following details:
- SIS Code (if available)
- Company name of the MAH
- Address
- Country
- VAT number
- Tax code (if available)
- Single Point of Contact (name + email, if available)
- Certified email (PEC) if available
- Entrance Fee Payment – Pay the Entrance Fee after receiving the proforma invoice.
- Onboarding Contract – After verifying the documentation and payment, the company will receive the onboarding contract template for signature.
- Annual Fee Payment – Pay the annual fee as invoiced.
