[Blog] Kazakhstan officially announced the labelling and traceability requirements
Meet the approved Order of MoH # KR-DSM 11 Rules for Labelling and Traceability for Kazakhstan
Earlier this week, the Minister of Health of the Republic of Kazakhstan shared amendments to the order dated January 27, 2021, No. KR DSM-11 “On Approval of the Medicines and Medical Devices Labeling Guidelines”. The documents are specified the official requirements for serialization and aggregation of medicines that will become effective from 1st August 2022. The regulation does not specify waves and implementation timelines, as another Government Decree states that 1st wave will need to be serialized for products in scope produced after 1st July 2022.
The highlight of the essential points:
- Users of the system can be representative offices or affiliates of international manufacturers, foreign manufacturer’s trusted representatives, MAH, manufacturers and affiliated companies. API, radiopharmaceuticals, exported medicines, samples, and ATMP are exempt from serialization.
- Products manufactured and (or) imported before the regulatory requirement for serialization may be stored and marketed until product expiry.
- Requirements remain as follows GTIN, Serial Number, Crypto and Crypto key. As for the serialization, is allowed to be used stickers
- There is a complete list of exemptions that indicate for which medicinal products do not apply labelling
Regarding the aggregation, it 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 packaging;
2) aggregation of the second level – combining transport packages into another transport package of a higher level of nesting.
The Ministry of Kazakhstan has been working on developing a traceability system since 2018, aiming to effectively fight the counterfeiting of drugs. The deadline for 100% mandatory serialization is 2023.
You can discover detailed information about Kazakhstan’s regulations, exemptions and traceability pros.