FAQ
Welcome to our Frequently Asked Questions (FAQ) section! Here you will find answers to the most common questions regarding our services, contact methods, response times, and much more. Our goal is to provide you with all the information you need in a clear and quick way.
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What is the National Medicines Verification System (NMVS)?
The NMVS is a national system designed to verify the authenticity of prescription medicines, preventing the distribution of counterfeit products.
Who must use the NMVS?
The system is mandatory for pharmaceutical manufacturers, wholesalers, and pharmacies, in compliance with European medicine safety legislation (Directive 2011/62/EU and Delegated Regulation 2016/161).
How does medicine verification work?
Each medicine package is equipped with a unique code (Data Matrix) that is scanned and verified in the national database before dispensing.
Which medicines must be verified under Regulation 2016/161?
All prescription-only medicines, except those listed in Annex I of Delegated Regulation 2016/161, as well as certain over-the-counter medicines specified in Annex II of the Regulation, are included.
How does the regulation apply to SOP/OTC medicines?
OTC (Over-The-Counter) medicines are not subject to the European regulation, and therefore the current identification system using the sticker label (“bollino”) established by Ministerial Decree of 30 May 2014 remains in force for these products. However, the safety feature provided for by the EU Regulation — the Anti-Tampering Device (ATD) — may be applied to these medicines and will become mandatory starting from 9 February 2027.
Who must pay the entrance and annual fees?
All MAHs (Marketing Authorization Holders) registered in Italy must pay the entrance and annual fees to support the costs of establishing and managing the National Archive containing the safety features data of medicines.
Who are the invoices for entrance and annual fees issued to?
Invoices for the payment of entrance and annual fees may be issued exclusively to the company that holds the Marketing Authorization.
How can manufacturers register their medicines in the NMVS?
Pharmaceutical companies must register with the National Medicines Verification Organization (NMVO) and upload their product data into the European Medicines Verification System (EMVS – EU HUB).
What must pharmacies do?
Pharmacies must scan the medicine’s unique code before dispensing it to the patient to confirm its authenticity and proceed with its deactivation.
What happens if a medicine is found invalid?
If a medicine fails verification, it must be immediately reported and cannot be dispensed until further investigation.
What characteristics must the Data Matrix and the security device on security paper have?
The technical specifications are defined by specific ministerial decrees provided for in Legislative Decree 10/2025.
When will sanctions for failure to apply the safety features be enforced?
Sanctions for the failure to apply and activate the Data Matrix, the anti-tampering device (ATD), and the ecurity-featured support (carta valori) will not be enforced until the end of the stabilization period, that is, until 8 February 2027.
What is foreseen in Legislative Decree No. 10 of 6 February 2025?
The decree adapts national legislation to the European medicines serialization system, establishing a transition period for the implementation of new safety and identification requirements for medicines.
What happens to batches of medicines released up to February 8, 2025?
These batches can be marketed with the current adhesive sticker until their expiry date, without obligation to comply with the new requirements.
What are the provisions for medicines subject to the Directive during the stabilization period (9 February 2025 – 8 February 2027)?
During the stabilization period, QPs (Qualified Persons) may release batches with two different configurations:
- Batches with only the Bollino sticker label as regulated by the Ministerial Decree of 30 May 2014 (for all medicinal products for human use, both prescription and non-prescription).
- Batches with Data Matrix, anti-tampering device (ATD), and a security-featured support (carta valori) in force during the stabilization period.
Can both national and international acronyms be indicated in the HRI?
The acronyms shown next to the Data Matrix for the HRI must be those indicated in the Ministry of Health’s March 6, 2025 Decree (so-called “Data Matrix Decree”) containing the technical specifications of the Data Matrix (Annex A – point 6), namely:
- PC: product code
- SN: serial number
- LOTTO: batch number
- SCAD: expiry date
- AIC: national reimbursement number
Where can I find more information about the legislation?
You can consult the “Documentation & Archive” section on the NMVO website and on the Ministry of Health website, under the drug traceability section, package identification.
