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kazakhstan

Kazakhstan – New Regulations for Medicinal Products in the Pipeline

The Ministry of Health in Kazakhstan is introducing changes to the existing legislation for distribution of pharmaceutical products and medical devices with the view to improve regulation of prices and ‘create a patient-oriented drug provision model.

According to a new draft law, in October 2018 regulated prices will be introduced for all prescription pharmaceutical products with OTC drugs following suit in 2023. A new regulation anticipates a two-pronged approach to patient groups. Those who began the treatment will continue getting access to the pharmaceutical products purchased under INN names. For new patients, it is proposed to hold tenders on procurement of lower priced biosimilars and generic products.

The healthcare authorities will draw up a list of diseases and patient categories for procurement of medicinal products under trade names based on the evaluation of the clinical significance of the disease and severity of clinical effects resulting from drug substitution. Both pharmaceutical products and medical devices will be selected following a comprehensive assessment of health technologies.

Valued at circa $1.2bn, the Kazakhstan pharmaceutical market is the largest one among post-Soviet states in Central Asia. The hospital sector and public procurement account for around 40% of the market. The share of imported drugs is estimated at 84%.

All pharmaceutical products must be registered in Kazakhstan. The National Centre of Expertise (a Ministry of Health Agency) oversees the product approval and certification process. The regulatory environment is set to improve in the coming years as the country’s new international agreements provide the basis for positive developments in this area.

For further information regarding regulatory submissions, MA approval and national authorisation procedures in Central and Eastern Europe, please contact Klaus Doring at Grove Group Pharmaservices klausdoring@groveonline.com or visit our website www.groveonline.com .