FAQs answered for you.

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.