A pharmacy should never say out of stock.

Committee for Medical and Pharmaceutical Control, Ministry of Health RK · applied via elicense.kzImport is not licensed separately in Kazakhstan; it sits inside the statutory definition of wholesale, which covers acquisition, storage, import, export and sale. Non-transferable.

Pharmaceutical inspection under Order ҚР ДСМ-9 (27 Jan 2021)Standard set by Annex 4 to Order ҚР ДСМ-15 (4 Feb 2021). Applies to every party in the distribution chain regardless of ownership.

Sanitary Rules ҚР ДСМ-58 (2021) · Storage and transport rules ҚР ДСМ-19 (2021)Separate reception, main storage and special-storage zones; controlled temperature; validated cold chain where the product requires it.

Appointed internally; qualification set by Order ҚР ДСМ-148/2020Warehouse manager must hold higher pharmaceutical education plus three years of relevant experience.

Ministry of Justice RKAn LLP is the standard vehicle. Full foreign ownership is permitted in pharmaceutical distribution; no local-director requirement.

EEC Council Decision No. 78 (3 Nov 2016) · expertise by NCEMD / NDDAMutual-recognition or decentralised procedure. Reference-state assessment up to 210 days; each recognition state up to 90 days. The national-only route is closed to new products.

Pharmaceutical inspectorate of an EAEU member state · Decision No. 83 (2016), amended by No. 127 (2022)Since Council Decision No. 34 took effect on 21 June 2025 the EAEU GMP certificate is no longer required at dossier submission; the Indian WHO-GMP document, three years of inspection reports and a site master file may be filed instead, with EAEU inspection completed within three years after registration.

State expert organisation · Order ҚР ДСМ-282/2020Every batch entering the country is assessed against the registration dossier. Certificate of Analysis plus notarised and apostilled GMP documentation required per consignment.

Ministry of Health RKSecondary packaging and the patient information leaflet must both be provided in Kazakh and Russian.

State track-and-trace operatorSerialised identification codes applied at pack level and reported through the national traceability system.

Standard set by Annex to Order ҚР ДСМ-15 (GVP)Adverse-event collection and reporting obligations, with a designated contact for the authority.

Ministry of Health RKA registered maximum price is a commercial precondition for sale, separate from marketing authorisation.

State Licensing Authority / State FDA, following joint inspection with CDSCOUnderlying standard is Revised Schedule M to the Drugs and Cosmetics Rules. CDSCO maintains the national list of WHO-GMP certified units.

State Licensing Authority for the state of manufactureProduct-specific, WHO format. Must be notarised and apostilled through the Ministry of External Affairs for use in Kazakhstan.

State Licensing Authority, Drugs and Cosmetics Act 1940Form 25 for drugs outside Schedules C, C(1) and X; Form 28 for Schedule C and C(1) products.

State Licensing AuthorityEvidence that the product is freely sold in the country of origin.

Pharmaceuticals Export Promotion Council · Directorate General of Foreign TradeRequired to export pharmaceutical formulations from India and to claim export benefits.

Directorate General of Foreign TradeSerialisation and barcoding on tertiary, secondary and primary packaging for exported formulations.