the criteria for selecting medicinal products for the State Formulary are:
- Availability of state registration of the medicinal product (as of 01 September of the current year) and at least two years of experience of its use in Ukraine. If there are no therapeutically equivalent medicinal products, experience of use of the medicinal product in Ukraine is not required.
- Availability of high indicators of quality, efficacy, safety and cost-effective use of medicinal products, confirmed by:
2.1. Availability of a document confirming that the manufacturing conditions comply with the requirements of good manufacturing practice (for domestic manufacturers – a valid license for the manufacture of medicinal products).
2.2. Evidence-based medicine data, including the results of pharmacoeconomic studies.
2.3. The practice of medical use, including the results of the assessment of the safety of medical use of the medicinal product, as defined by the Procedure for Pharmacovigilance of Medicinal Products Authorized for Medical Use, approved by order of the Ministry of Health of Ukraine of 27 December 2006 No. 898, registered with the Ministry of Justice of Ukraine on 29 January 2007 under No. 73/13340.
In accordance with: clause 6. of the Methodology for Creating Medicinal Product Formularies, approved by order of the MoH of Ukraine of 22.07.2009 No. 529 (as amended).
