Suspension of registration of medicine in Ukraine could lead to disappearance of some medicine, say experts
Kyiv, May 25 (Interfax-Ukraine) – The blocking of the registration of imported medicine due to flaws in Ukrainian law could lead to the disappearance of some medicine from the Ukrainian market, experts say.
"If the situation does not change, there is a risk of the disappearance of certain medicines," coordinator of the European Business Association (EBA) Health Care Committee Natalia Serhiyenko, said at a press conference at Interfax-Ukraine on May 24, 2012.
She said that companies that import medicine to Ukraine now cannot even start the registration procedure at the State Expert Center. This was a result of discrepancies between the law on medicine and a cabinet resolution regulating relevant issues, and the absence of regulations covering relations between the state bodies involved in the registration of medicine in Ukraine at various stages.
"The registration is a basic condition for imports of medicine. The absence of registration means the absence of sales in Ukraine. The main reason is conflicting legislation," she said.
The committee coordinator said that the State Expert Center does not allow companies to start the registration procedure for medicine if the companies do not have the confirmation of the conditions of medicine production, and if the examinations were commenced, they were suspended.
Serhiyenko said that the EBA is alarmed at the fact that pharmaceutical companies that are importers of medicine are being badly affected by the situation.
"If proper steps to unblock the registration and re-registration processes are not taken, new medicines for Ukraine, as well as [some of] those previously sold, will be absent from the market, and Ukrainian patients will suffer," she said.
Head of the Registration Subcommittee of the European Business Association Health Care Committee, a representative of Polpharma Angela Kupych, said she shared the opinion of her colleague, adding that it would take around six months to bring the legislation to order and settle the issue.