FAQs answered for you.

Yes, the depositary can carry out the operation on behalf of the AIC holder if this is expressly provided for in a written contract. However, the AIC holder remains the only party legally responsible for this activity. 

The obligation lies with the Marketing Authorisation Holder (AIC holder), who must flag the pack as a free sample in the repositories system (by setting the status FREE SAMPLE) and ensure it is deactivated before supplying it to the persons authorised to prescribe it, as required by Article 41 of Regulation (EU) 2016/161 for samples supplied under Article 96 of Directive 2001/83/EC. 

Free samples must carry the same safety features as the product for sale, with decommissioning before distribution to doctors. For samples with a reduced content, it is possible to assign a dedicated GTIN to the sample pack and enter it as a separate product in the Product Master Data in the system. In this way the inconsistency between the physical content of the pack and the declared data disappears. It has been confirmed with GS1 that two different GTINs can be associated with the same AIC code when the packs differ in the quantity of content.

From a technical point of view, both options are possible. The regulations state that the product code (GTIN) is assigned by the manufacturer, so the choice mainly depends on the company’s needs. • One GTIN per AIC: this is the most common standard for physically identical products. • A different GTIN per channel: this gives more detailed data (for example for samples, which have the same AIC but a smaller pack size). 

In this scenario it is correct to use a single GTIN. If in the future the company decides to produce batches intended for the hospital channel, it will be correct to assign a dedicated GTIN. 

Yes, that is correct. If the packs are different from the start (for example because the security paper device is cancelled only for the hospital channel), it is correct to use two different GTINs. The NMVS has no problem managing several GTINs under the same AIC, as long as they are all uploaded to the EU Hub. The rule is that one GTIN cannot identify two different items. 

To facilitate manual verification in case of optical reading problems, the key information of the Data Matrix code is printed in textual format on the packaging:

• PC → Product Code (GTIN)
• SN → Serial Number
• LOTTO → Batch Number
• SCAD → Expiration Date
• AIC → National reimbursement number

These pieces of information are preferably positioned near the two-dimensional barcode to facilitate reading.

The HRI information must be printed as indicated in the “Data Matrix” Decree (Ministry of Health Decree of March 6, 2025, Annex A – point 6).