The procedure for simplified registration of medicines registered in countries with a strict regulatory system was not perfect from the very beginning, but since the start of the armed aggression, its shortcomings have deepened and it has become ineffective, says Maryna Buchma, the director of government relations at Teva Ukraine LLC pharmaceutical company.

"The simplified procedure provided for the registration of medicines registered in countries with a strict regulatory system was not perfect from the very beginning, there were many questions and comments about it," Buchma said in a comment to the Interfax-Ukraine agency.

She explained that during the period when the Ministry of Health could hold meetings-sessions to discuss the conclusions of the state expert center, registration was possible, although often with a delay in time. However, since the beginning of a full-scale war, such meetings have not been held, the applicant is not able to confirm compliance with all legal norms.

"This factor and other imperfections, which all participants of the procedure talk about, have now made it ineffective," the top manager said.

Commenting on the recent refusal of the Ministry of Health to register nine Teva drugs, she noted that from 2016 to 2022, the pharmaceutical manufacturer registered ten medicines in Ukraine under a simplified procedure.

"Over the years, we have received two refusals in simplified registration. The last registration under this procedure in 2022 lasted 203 days from submission for approval (registration of drugs under the standard procedure is carried out within 210 days). Since the beginning of 2023, we have received five refusals to register under the simplified procedure for applications in 2021 and 2022. These are new registrations. We, as applicants, do not see conclusions. Most likely, they indicate formal inconsistencies in the dossier, which we are not able to refute, because we do not know the reasons," she said.

Buchma noted that one of the reasons for refusal of registration may be, in particular, that the trade name chosen for the Ukrainian market differs from the name of such a medicinal product in the reference country, which can be interpreted as a discrepancy.

At the same time, according to her, medicines, which the Ministry of Health refuses to register, have registered analogues "with the same molecule, in the same dosage form."