FAQs answered for you.

According to the FAQ published on the Ministry of Health website (Annex 2 of Operating

Instructions no. 1 under Article 13, paragraph 4, of Legislative Decree no. 10 of 6 February 2025 Link:

https://www.salute.gov.it/new/sites/default/files/All.%202%20-%20FAQ.pdf), the HRI must be

grouped together in a compact form and stay next to the Data Matrix. It is therefore not possible to

spread PC, SN, LOT and EXP over different flaps.

The Decree of 6 March 2025 provides that the HRI should, where possible, be adjacent to the twodimensional barcode, while the AIC may be non-adjacent to the optical code but must be as close as

possible. The AIC should therefore preferably be on the same panel or, depending on the size of the

carton, on another side as close as possible to the Data Matrix.

For small cartons, we recommend asking AIFA for official feedback.

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.

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

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). 

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.

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

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. 

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.

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.

According to Delegated Regulation (EU) 2016/161 (and the related clarifications of the European

Commission in Q&A 8.5), free samples must carry the same safety features as the product intended

for sale.

In addition, for medicines placed on the market in Italy (under Article 4, paragraph 3 of Decree

10/2025 on the Security Paper Device), the following wording must be clearly shown on the pack in

indelible ink: «CAMPIONE GRATUITO - VIETATA LA VENDITA» (“FREE SAMPLE – NOT FOR

SALE”)

As stated in the FAQ published on the Ministry of Health website (Annex 2 of Operating Instructions no. 1 under Article 13, paragraph 4, of Legislative Decree no. 10 of 6 February 2025 Link: https://www.salute.gov.it/new/sites/default/files/All.%202%20-%20FAQ.pdf), once the Security Paper Device “Annex A” is applied to the packs, the wording “Confezione dispensata dall’SSN” (“Pack dispensed by the SSN”) will no longer be necessary.

This is a solution that requires caution. A transparent seal placed over the Data Matrix may cause reflections or distortions and affect correct scanning along the supply chain. If the verification of the safety features cannot confirm the authenticity of the medicine because of reading problems, the system raises a potential falsification alert. We recommend carrying out readability tests with the manufacturer

No. The human-readable information (HRI) must be the exact interpretation of what is encoded in the Data Matrix. Adding an identifying letter in plain text only, even if separated from the batch, could be seen as a data mismatch during manual checks, increasing the risk of false alerts of possible falsification. 

As stated in the FAQ published on the Ministry of Health website (Annex 2 of Operating Instructions

no. 1 under Article 13, paragraph 4, of Legislative Decree no. 10 of 6 February 2025 Link:

https://www.salute.gov.it/new/sites/default/files/All.%202%20-%20FAQ.pdf), the price may be

printed on the fifth line. The price is not an HRI element and therefore must not be included in the

GS1 Data Matrix.

The HRI sequence must be the same as the one in the Data Matrix: the string encoded in the Data

Matrix must therefore follow the order used on the pack, with the AIC as the last element.

For any further doubts, we recommend contacting the National Competent Authorities.

As regulated by the Ministry of Health Decree of March 6, 2025,the Data Matrix code is composed of five essential elements:

1. Product Code (GTIN – Global Trade Item Number)

• A 14-digit number that identifies the medicine, including the name, pharmaceutical form, dosage, and packaging type.
• Constructed according to the GS1 system specifications.

1. Serial Number

• A numeric or alphanumeric sequence (up to 20 characters).
• Randomly generated by the manufacturer through a randomization algorithm.

1. AIC Code (Marketing Authorization Number)

• A 9-digit number assigned by the Italian Medicines Agency (AIFA) for authorization to market in Italy.

1. Batch Number

• An alphanumeric code (up to 20 characters) that identifies the production batch of the medicine.

1. Expiration Date

• Indicated with 6 digits in the format YYMMDD (Year, Month, Day).
• 01 → GTIN (14 digits)
• 21 → Serial number (up to 20 characters)
• 10 → Batch number (up to 20 characters)
• 17 → Expiration date (YYMMDD)
• 716 → AIC code (9 digits)

As stated in the FAQ of the National Competent Authorities (Annex 2 of Operating Instructions no.

1 under Article 13, paragraph 4, of Legislative Decree no. 10 of 6 February 2025 Link:

https://www.salute.gov.it/new/sites/default/files/All.%202%20-%20FAQ.pdf), the sequence of

the GS1 Data Matrix code and that of the related HRI must match exactly. In addition, in line with

GS1 standards, the GTIN must always come first.

Different sequences (for example GTIN + SN + EXP + LOT + AIC, or GTIN + LOT + EXP + SN +

AIC) are therefore valid, even across different production sites, provided that:

• the GTIN stays in the first position;

• the HRI faithfully reflects the Data Matrix.

The status of designated wholesaler can be proven only through the written contract between the depositary and the Marketing Authorisation Holder (AIC holder). 6 As stated in the EMVS Master Data Guide, the Marketing Authorisation Holder must also provide the list of wholesalers (ID, name and address) when uploading the Product Master Data to the EMVS. The designation is not visible to NMVS users: for this reason, Appendix 5 of the EMVS Master Data Guide recommends showing the AIC holder, the designated wholesaler and the recipient on transport documents (delivery notes and invoices). 

No. The AIC code is a 9-digit number: any “/E” or “/M” suffixes must be excluded from both the Product Master Data and the Data Matrix. 

No. The coding requirements for Italy have been included in the latest revision of the EMVO guide (EMVS Master Data Guide v.10.0 of 15 October 2025). As required by Legislative Decree 10/2025, for Italy you must upload the GTIN as Product Code and the AIC (in the 8+1 format) as the mandatory National Code. Under the Regulation, this means the AIC must also be shown in human-readable format (HRI) on the pack. 

Yes. The Product Code (PC) corresponds to the GTIN, a 14-digit numeric code assigned by the manufacturer according to GS1 standards. On the pack, the HRI (Human Readable Interpretation) must show the abbreviation “PC” followed by the GTIN code.