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Frequently Asked - Find answers to common questions about Track & Trace

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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. 

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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. 

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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). 

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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.

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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. 

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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. 

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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. 

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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. 

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Registration is optional for foreign manufacturers. They must either register through their KSA scientific office or authorize an agent to manage their account via authorization form.
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Yes. All legally registered invoicing companies must enroll, sign a Participation Agreement, and pay required fees to support hub maintenance.
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Yes. All supply chain participants must obtain a Global Location Number (GLN) to identify their organizations and key operational locations per the traceability directive.
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Serialisation is the application of a GS1 approved 2D Matrix barcode and human readable information onto all drug secondary packing. This enables unique identification of each product unit.
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Tatmeen became operational on December 13th, 2022, which was 18 months after the decree was issued on June 14, 2021.
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No, the RSD system rejects duplicated license numbers or GLNs for multiple registrations. Each entity must have unique identifiers.
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Invoicing Companies and Marketing Authorization Holders must register with GS1. GLN and GCP information can be found using the GS1 Lookup Directory and GTIN Management site.
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Yes, both registrations are required. BrandSync submission is mandated by the Medicines Barcoding and Serialization Guideline for product master information. NHRA-MVC tracks medicines from shipment through dispensing.
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Supply Chain Partners are organizations collaborating to move pharmaceuticals from manufacturer to consumer. This includes MAHs (Marketing Authorization Holders), Licensed Agents, 3PL companies, and dispensaries.
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Aggregation defines parent-child barcode relationships, allowing receivers to scan one code and understand complete shipment contents. Serialized GTINs are used at unit and case levels; SSCC applies to pallets.
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Yes, it is mandatory to register each location independently and track operations between them.
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The process involves 10 steps: obtaining a Company Prefix, assigning numbers, selecting printing processes, environments, barcode types, sizes, formatting, colors, placement, and building quality plans.
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