“For applicants – natural persons and legal entities that are developers, manufacturers, or distributors of medicinal products!
The Procedure for the expert evaluation of the application and accompanying materials on the possibility of including a medicinal product in the State Formulary of Medicinal Products (hereinafter – the Application and Accompanying Materials) was developed in accordance with the Methodology for Creating Formularies of Medicinal Products, approved by MoH order No.529 of 22.07.2009 "On Creating a Formulary System for Providing Medicinal Products to Healthcare Facilities," registered with the Ministry of Justice on 29.10.2009 under No. 1003/17019.
The expert evaluation of the Application and Accompanying Materials may be preceded by consultations* on procedural matters and on the preparation and execution of the above documents. The consultations are aimed at optimizing the procedure for reviewing the above documents regarding the possibility of including a medicinal product in the State Formulary. Consultations are provided by the Head of the Healthcare Standards Department (hereinafter – HSD), the head and experts of the Medical Equipment and Medicinal Product Formulary Division of the HSD, and accounting staff.
Consultations may be held both before the start of the procedure for considering the inclusion of a medicinal product in the State Formulary and during the expert work, but only before the Applicant pays for the expert work.
The first stage of expert work is the primary evaluation**. Primary evaluation is the verification of whether the accompanying materials submitted correspond to the application, and of their compliance with the established requirements in terms of completeness of scope and correctness of formatting.
* – provided free of charge
** – performed free of charge
Subsequent expert work, which includes expert evaluation of methodological quality and specialized expert evaluation, may be carried out after a contract is concluded between the Center and individuals and legal entities that are developers, manufacturers or distributors of medicinal products proposed for inclusion in the State Formulary. The contract may be concluded after the conclusion based on the results of the primary expert evaluation has been received.
Methodological quality evaluation – verification of the availability of data and evaluation of the methodological quality of the submitted evidence of the efficacy and safety of a medicinal product in primary, secondary and tertiary sources of reliable information.
Specialized expert evaluation is a specialized assessment of the application and accompanying materials in order to provide recommendations on the advisability of including a medicinal product in the State Formulary in accordance with the inclusion criteria defined by the Methodology approved by MoH order of 22.07.2009 No. 529 "On the Establishment of a Formulary System for Providing Healthcare Facilities with Medicinal Products", registered with the Ministry of Justice of Ukraine under No. 1003/17019 of 29.10.2009 (as amended), followed by consideration at a meeting of the Central Formulary Committee of the Ministry of Health of Ukraine for the adoption of a final decision.
