Kazakhstan Regulatory Compliance

General Overview

In 2018, the journey of Kazakhstan towards building a traceability system started. In the next 3 years, the government constantly worked and planed the pharmaceutical track and trace process for serialization of all medicines. At the beginning of 2021, the Kazakh Ministry of Health published a pilot guideline for product marking and traceability.

In June 2022, amendments to the order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. KR DSM-11 “On Approval of the Medicines and Medical Devices Labeling Guidelines” were officially announced. The laid down rules are effective from 1^st August 2022.

By order of the Ministry of Health of the Republic of Kazakhstan dated 1 February 2023, the Rules for labelling and traceability of medicinal products have been suspended. The introduction of traceability has been postponed until 1 July 2024.

Users of the system can be representative offices or affiliates of international manufacturers, foreign manufacturer’s trusted representative, MAH, manufacturers and affiliated companies. API, radiopharmaceuticals, exported medicines, samples, ATMP are exempt from serialization.

Products manufactured and (or) imported before regulatory requirement for serialization may be stored and marketed until product expiry.

The following timeframe is currently defined:

Until July 1, 2024 (stage 1) – Mandatory labelling of 100% of drugs);
From July 1, 2024 (stage 2) – drugs purchased by the Single Distributor (for government procurement) (about 40%);
From January 1, 2025 (stage 3) – prescription drugs (about 30%);
From July 1, 2025 (stage 4) – non- prescription drugs (over-the-counter drugs) (about 30%).

Full traceability will be implemented from July 1, 2025.

Products manufactured and (or) imported before regulatory requirement for serialization may be stored and marketed until product expiry.

Exemptions

Requirements for labeling and traceability of medicines do not apply to:

1) medicines imported by individuals for personal use;

2) medicines intended for the treatment of passengers and crew members of vehicles, train crews and drivers of vehicles arrived in the customs territory of the Eurasian Economic Union;

3) medicines necessary for the treatment of participants of international cultural, sports events and participants of international expeditions;

4) medicines manufactured in pharmacies;

5) pharmaceutical substances (active pharmaceutical substances) produced under the conditions of good manufacturing practice;

6) pharmacopoeial medicinal plant raw materials, including as part of fees and consumer packaging;

7) medicinal products produced in the Republic of Kazakhstan only for export;

9) exhibition samples of medicines and medical devices necessary for holding exhibitions without the right of their further sale;

10) samples of medicines received for conducting preclinical (non-clinical) and clinical studies and (or) trials;

11) radiopharmaceutical medicinal products manufactured directly in healthcare organizations at the place of their application;

12) samples of medicinal products necessary for examination during state registration;

13) medicines of advanced therapy, produced for individual use using autologous biological materials of the patient or his donor, selected directly for him;

14) medicines intended for the provision of humanitarian assistance;

And other cases provided for in Article 8 of the Agreement on the labeling of goods by means of identification in the Eurasian Economic Union.