FAQs answered for you.

Yes. Under Article 13 of Legislative Decree 10/2025, during the stabilisation period (from 9 February 2025 to 8 February 2027) batches may be released with the current pharmaceutical bollino sticker, without serialisation safety features. These batches may remain on the market until their expiry date (even after 9 February 2027), without having to be repackaged or relabelled.

Article 2 of the Decree of 16 June 2026 requires manufacturers, depositaries and wholesalers to send

the Central Database the movements of medicine packs, including those leaving the distribution

channel, in the way described in the technical specification annexed to the decree, with reference to

the following information:

a) the sender;

b) the identification code of the marketing authorisation in Italy, issued by AIFA;

c) the corresponding number of packs;

d) the recipient of the supply;

e) where applicable, the production batch and the expiry date;

f) the economic value of supplies directly charged to National Health Service (SSN) facilities.

Manufacturers, depositaries and wholesalers therefore continue to send the MOV and FAT data.

Sending to the Central Database remains separate from sending to the NMVS: the two flows do not

replace each other.

No. Since these medicines have no AIC, because they are still under study and not authorised for marketing, they are excluded from the safety feature rules of Regulation (EU) 2016/161, as also confirmed by the European Commission’s Q&A 1.6. 

NMVO Italia’s goal is to have the Italian NAMS connected to the European AMS from 9 February 2027. 

No, and it is not necessary. The status of a pack belonging to an expired batch is set automatically

by the system to INACTIVE (Reason EXPIRED), even if its serial number has never had any

transaction (it was “active” at the time of expiry).

No further transactions can be made on these packs (e.g. Destroy, Stolen, Lock): the system replies

with the error NMVS_NC_PCK_30 without generating an alert. Alerts are generated only for packs with

the “Checked Out” property.

No further transactions can be made on these packs (e.g. Destroy, Stolen, Lock): the system replies with the error NMVS_NC_PCK_30 without generating an alert. The same behaviour applies to withdrawn batches (WITHDRAWN). 

From a technical point of view, the system allows special characters (e.g. dots, hyphens, percent signs) in both the batch number and the serial number, in line with GS1 specifications. However, the European Commission’s Q&A (2.23) recommend using capital letters and avoiding special characters, to reduce reading and manual entry errors. As for an expiry date with day “00”, the EU Hub accepts this value and reads it as the last day of the month indicated. The system is therefore able to handle both cases

When the Data Matrix of a pack intended for a foreign market is scanned, the system does not reject

the operation but starts an automatic procedure called Intermarket Transaction (IMT).

The verification flow has the following steps:

1. Local check: the local NMVS carries out an initial check in its own database.

2. Forwarding to the EU Hub: as it does not find the serial number data in its own repository, the

NMVS forwards the verification request to the EU Hub.

3. Identification of the competent country: the EU Hub identifies the relevant National System

(in this case the Spanish one) and forwards the request to it.

4. Verification and reply: the destination NMVS checks in its own repositories whether the

unique identifier exists and what its status is (for example “Active”). The result is sent to the

EU Hub, which redirects it to the local NMVS to confirm the operation to the user.

5. Synchronisation: finally, the status is updated in the national repositories involved.

In an Intermarket Transaction, the NMVS does not return the product master data; in addition, the

reply contains the notification NMVS_NOTIFY_IMT_01.