Yes, they can, if a medicinal product has already been included in the State Formulary but over time has ceased to meet the requirements of any of the significant criteria:
- the state registration has expired;
- there have been changes in the instructions for medical use of the medicinal product which have indications that do not correspond to the section in the structure of the Formulary where this medicinal product was previously included;
- new data from clinical trials and observations have emerged regarding the absence of quality, efficacy or safety parameters (reports of serious adverse reactions) of a medicinal product, and the results of pharmacoeconomic studies regarding the absence of high indicators of cost-effective use of the medicinal product.
Such a medicinal product is subject to exclusion. Because, in accordance with the Methodology approved by order of the Ministry of Health of Ukraine dated 22.07.2009 No. 529 "On the Creation of a Formulary System for the Provision of Medicinal Products to Healthcare Institutions" (as amended), the State Formulary of Medicinal Products is a list of medicinal products registered in Ukraine that includes medicines with proven efficacy, acceptable safety and cost-effective use.
