Ministry of Health of Ukraine, with the participation of State Enterprise “State Expert Center of the Ministry of Health of Ukraine” and State Service of Ukraine on Medicines and Drugs Control, held an information meeting “Regulation of the Medical Cannabis Market” with representatives of business, pharmacy chains, and distributors.
Svitlana OSADCHENKO, Director of the Pharmaceutical Activity Department of the Center, during the meeting emphasized the relevance of the issue and stressed that the Center’s experts are ready to conduct an expert evaluation of registration materials for cannabis plant substance produced from hemp for medical purposes, since, in accordance with the Law of Ukraine “On Medicinal Products”, active substances (APIs) are classified as medicinal products.
In order to improve the expert evaluation of materials on active pharmaceutical ingredients (APIs) submitted for state registration, a draft order of the Ministry of Health of Ukraine “On Amendments to the Procedure for Expert Evaluation of Registration Materials for Medicinal Products Submitted for State Registration (Re-registration) and Expert Evaluation of Materials on Amendments to Registration Materials during the Validity Period of the Registration Certificate” has been developed and submitted to the MoH, which provides for shortening the time frame for expert evaluation of materials on APIs submitted for registration from 90 working days to 30 working days by amending Section VII of Procedure No. 426, as amended.
The conduct of the expert evaluation, at the applicant’s request, is preceded by free consultations provided by the Center, – S. Osadchenko emphasized. She also noted the Center’s openness to resolving current issues in the field of medicinal product registration.
