[Blog] Kyrgyzstan – the next EAEU country, introduced the mandatory serialization
The government of Kyrgyz Republic has taken measures against drug counterfeiting, including the medicines in the binding product list for labelling.
As early as 2019, the Kyrgyz Republic Government issued Decree No. 470/12.09.2019 for the “Product Marking identification in the Kyrgyz Republic” and Decree No. 554/17.10.2019 The procedure for product labelling with digital identification in the Kyrgyz Republic, followed by a pilot project that was conducted. In September this year, the government published Order No. 1110/09.20.2022 – Traceability system for medicines and medical devices identification of the Kyrgyz Republic that specifies the track and trace requirements for pharmaceuticals.
The National Authority that generates and issues labelling codes is Alfa Telecom CJSC, as the national system is АИС «Маркировка товаров» / АИС MT. The supply chain participants must comply with the requirements for the developed Kyrgyz platform – Teksher.
Serialization requirements include 2D DataMatrix code with GTIN, serial number (SN), and verification code (cryptotail). The human-readable part must consist of GTIN, serial number (SN), Batch number and Expiry date.
The identified types of serialization are Internal marking (into the Kyrgyzstan territory) and external (cross-border for EAEU countries) marking.
- External marking: Decree No. 577/08.05.2019
External (cross-border) marking is voluntary for import to the EAEU countries
- Internal (mandatory) marking:
Mandatory on the territory of the Kyrgyz Republic.
The circulation of non-labelled products is prohibited according to the current legislation.
– Decree of the Kyrgyz Republic Government No. 83/18.02.2013
– Order Antimonopoly Regulation Services under the Ministry of Economy and Commerce of the Kyrgyz Republic No. 36/19.09.2022
The specified steps for successful registration in the platform are as follows:
- Manufacturers & Importers have to be registered in GS1 Kyrgyzstan – http://gs1kg.org/
- Registration to Kyrgyz HUB – Teksher – https://main.teksher.kg/about.html
- Sign a contract with Alfa Telecom CJSC
- Sign a contract with a solution provider
Voluntary implementation waves are planned for 1) January 2023; 2) April 2023; 3) August 2023 – voluntary serialization. From September 2023 serialization will become obligatory for all products – this is linked to EAEU’s requirement to inform Eurasian Commission 9 months before implementing serialization. The Department of Medicines will compile voluntary lists.
- Transition period
A 2-year transition period is laid down, meaning that serialized products with any country labelling will be allowed for 2 years. From September 2023, all products to be imported must be serialized according to Kyrgyz requirements, but also any country labelling will be allowed (e.g. Russia, Uzbekistan, Kazakhstan labelling).