Since September 1, 2017, the medicinal products registered and included in the National List of Essential Medicinal Products (hereinafter referred to as the National List) are to be purchased by healthcare institutions wholly or partly funded from the state and local budgets. These requirements do not apply to medicinal products purchased by the Ministry of Health on the basis of contracts with specialized organizations effecting the purchases.
The National List is approved by Cabinet of Ministers of Ukraine, Decree No. 333 dated March 25, 2009.
Inclusion of the medicinal product in the National List is conducted by the Expert Committee for Selection and Use of Essential Medicinal Products based on the provision approved by the Ministry of Health of Ukraine.
To include the medicinal product in the National List, the Application shall be submitted along with the documents confirming the comparative efficiency (performance), comparative safety, and economic feasibility of the medicinal product.
Economic feasibility of the medicinal product is justified by modeled pharmacoeconomic analysis based on different types of analysis (cost of illness, cost-effectiveness, cost-usefulness, budgetary impact, cost minimizing, etc.).
The documents also include the information on medicinal product pricing in other countries of the world and the proposed pricing model for Ukraine.
The documents are prepared on the specific indication for use of the medicinal product in question.
Expert Committee for Selection and Use of Essential Medicinal Products reviews the submitted Applications and the supporting documents within 180 days, in order of priority. Following the decisions made on the reviewed applications, the Expert Committee forms, till July 1 of the current year, the next revision of the National List, which is submitted for approval to the Ministry of Health of Ukraine.
Cratia offers our professional assistance in preparing the Application and the package of documents for the medicinal product inclusion in the National List. Please note that we do not offer a guaranteed inclusion of the medicinal product in the National List.