FAQs answered for you.

NHRA-MVC (Medicine Verification Center) is Bahrain's pharmaceutical track and trace system, operated by the National Health Regulatory Authority (NHRA).

View Bahrain regulations

Jordan's serialization requirements are managed by the Jordan Food and Drug Administration (JFDA):

• Unit-level serialization with DataMatrix barcode
• GTIN, serial number, batch, and expiry encoding
• EPCIS event reporting
• Focus on high-risk and imported products initially

View Jordan regulations

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).

The decision to conduct a pilot drug labeling project was made in December 2018. And since September 2019, it has been launched, for which methodological

recommendations for this procedure were approved, a list of participants in the pilot project and medicines subject to labeling within its framework was determined.

At the same time, in October 2020, by order of the Prime Minister, a comprehensive plan for the development of the pharmaceutical and medical industry for 2020–

2025 was approved, which also includes issues of labeling medicines. As for the pilot project, it was completed on July 31, 2021. According to the Kazakhstan Pharmaceutical Bulletin, 23 representatives of the pharmaceutical industry, including manufacturers, distributors, pharmacy and medical organizations, took part in the pilot. Based on the results of the pilot project, recommendations were sent to improve the marking and traceability information system. The first stage of mandatory labeling of 90 types of medicines began on July 1, 2022,

of which more than 80% of medicines are produced by 4 domestic manufacturers. A number of domestic manufacturers managed to purchase equipment for marking, joined the IS MPT, but not all market participants are ready to fully implement the project. Taking into account the risks of reducing the availability of medicines, the

insufficient readiness of the information system, due to the lack of integration of the information system for labeling and traceability of goods, the Ministry of Health of the

Republic of Kazakhstan has developed amendments that suspend the mandatory labeling and traceability of medicines until July 1, 2024.

The following sequence is currently defined:

 from July 1, 2024 (stage 2) - drugs purchased by the Single Distributor (about 40%);

 from January 1, 2025 (stage 3) - prescription drugs (about 30%);

 from July 1, 2025 (stage 4) - over-the-counter drugs (about 30%)

Full traceability will be implemented from July 1, 2025.

Expired products are reported as a “Decommission Event.”

Example: Batch B123 expired Dec 2026 → all serials from B123 marked “Decommissioned – Expired.”

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. 

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.

The shipping site (factory, importer, or 3PL) records the EPCIS “Shipping Event.”

Example: Factory GLN 10001 → ships SSCC 00312345678901234567 → Distributor GLN 20001

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)

The entity must record a "Return" event on the system. If the return involves products previously marked for export, it must specifically be labeled as "from Export" to maintain a clear history of the pack's location.

Pharmacists or hospital staff scan the serials before giving it to the patient. The system verifies validity and records a “Dispense Event.”

Example: serial SN000000123456 → status updated to “Dispensed.”

The manufacturer or importer initiates a “Recall Event.” All affected serials are blocked. Pharmacies scanning them will receive “Invalid – Recalled.”

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.

Yes. All entities (factories, distributors, pharmacies, and hospitals) must acquire 2D Scanners capable of reading Data Matrix codes and decoding them for the system.

Pharmacies must stop the sale of any unit with an unverified or invalid code and report it immediately to the EDA.

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. 

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.

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.

The system tracks "exits" through several specific event types:

• Dispensing: When a pharmacy or hospital gives the medicine to a patient.
• Destruction: Used to report packs that are damaged or expired and must be disposed of.
• Sampling: When packs are pulled from a batch for quality testing or research.
• Stolen/Missing: To report units that are lost or involve criminal activity.