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.

 

This regulation does not specify waves and implementation timelines. The laid down rules are effective from 1st August 2022. There is another Government Decree stating that 1st wave will need to be serialized for products in scope produced after 1st July 2022.

 

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.

Exemptions

Labeling of medicinal products with means of identification does not apply to:

 

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

2) medicines necessary for the treatment of participants in international cultural, sporting events and participants in international expeditions;

3) medicines manufactured in pharmacies;

4) pharmaceutical ingredients (active pharmaceutical ingredients) produced under the conditions of good manufacturing practice;

5) pharmacopoeial medicinal herb materials, including as part of herbal repertories, and in consumer packaging;

6) medicines produced in the Republic of Kazakhstan only for export;

7) exhibition samples of medicines and medical devices necessary for holding exhibitions without the right to their subsequent sale;

8) samples of medicinal products received for preclinical (non-clinical) and clinical trials and (or) studies;

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

10) samples of medicines required for examination during state registration;

11) advanced therapy medicinal products manufactured for individual use using autologous biological materials of the patient or his donor, selected directly for him;

12) medicines produced and (or) imported before the introduction of labeling and traceability of medicines, which are stored and sold until the expiration date;

13) the cases provided for in Article 8 of the Agreement on the marking of goods by means of identification in the Eurasian Economic Union, ratified by the Law of the Republic of Kazakhstan “On ratification of the Agreement on the marking of goods by means of identification in the Eurasian Economic Union”.

Regulatory Requirements

GTIN (Global Trade Item Number)

Serial Number

Crypto

Crypto key

 

* Using stickers for serialization is allowed

Aggregation

Aggregation is carried out in the presence of several levels of nesting:

 

1) aggregation of the first level – the combination of primary and (or) secondary packages into a transport package;

2) aggregation of the second level – combining transport packages into another transport package of a higher level of nesting.

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