FAQs answered for you.

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.

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.

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.

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). 

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)

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).

Drug labeling is the most important tool for controlling the movement of medicines through all supply chains from the manufacturer, distribution structure, pharmacies and

medical organizations to the end point - the patient, and an important step towards the digital economy. The introduction of mandatory labeling and traceability will make the

circulation of medicines more transparent and is one of the main tools for protecting against the circulation of counterfeit and falsified products, providing the buyer with the

opportunity to independently check the purchased drugs for authenticity, significantly reducing the costs of "flow" of medicines, simplifying the consolidation of information on

the balance of medicines, and also providing piece-by-piece accounting of individual packaging from the manufacturer to the patient.

In general, the introduction of labeling for the traceability of goods in Kazakhstan is carried out within the framework of the Agreement on Labeling Goods with Identification

Means in the EAEU, as well as the Law of the Republic of Kazakhstan “On Regulation of Trading Activities”, which came into force in the spring of 2019.

Marking is the application by the manufacturer or importer to the product, secondary or transport packaging of a special mark, which is an identifier confirming the

authenticity of the goods. Labeled medicines are medicines that have identification means and information about which is contained in the information system for marking and

traceability of goods (IS MPT), designed to provide information support for the processes of marking goods with identification means and their further traceability in the process of

circulation.

Identification tools contain a unique marking code, which is a combination of characters that includes 4 groups of data that meet international standards in the field of

accounting and bar coding GS1 DataMatrix. DataMatrix is a two-dimensional matrix barcode in the form of black and white elements or elements of various degrees of brightness, usually represented in the form of a square. A matrix barcode is used to encode text and other types of data. The code contains information about the manufacturer, country of origin, serial number and protection against hacking. At the same time, at the beginning of the marking code line, there is a sign of the symbolism of the barcode of an international organization in the field of standardization of accounting and bar coding of GSI, FNCI and ASC232 logistic units. A barcode is graphic information (a sequence of stripes or other geometric shapes)

that is applied to the packaging of goods for reading by technical means. Such a sequence can be assigned not only to a single product, but also to a group or transport package.

When marking, a two-dimensional matrix barcode "Data Matrix" will be used. It will make it possible to trace each package of a labeled medicinal product. It differs from

other types of codes in that it contains a larger amount of information compared to analogues, the possibility of placement in a small area and "survivability".

The code contains information about its own recovery and if the marking is damaged, it can be read even if 2/3 of the image is saved. In addition, the code cannot be

faked or changed, since the code is generated using cryptographic protection. Labeling of medicines with identification means is carried out by the participants

in the circulation of medicines (FACL) in accordance with the approved procedure for the Rules for the circulation of medicines, including the purchase, storage, import into the

territory of the Republic of Kazakhstan, production, labeling, transportation and sale of medicines.

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.

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. 

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, 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. 

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.