Experts alarmed with crucial omissions in open-ended reregistration of drugs - EBA

17:42, 10.06.2016 1 min read

Experts of the European Business Association (EBA) are alarmed with omissions in the drugs open-ended reregistration procedure that took effect in October 2015 and has not started working.

The EBA said in a press release one of the omissions is the absence of the approved form for open-ended registration certificate.

"The new drugs reregistration procedure took effect in October 2015. Companies received a chance to pass the reregistration procedure and receive open-ended registration certificates for drugs [instead of five-year certificates]. European practice was to start working in the area of reregistration of drugs. Would companies receive certificates if they successfully pass the procedure? There is no new form for the open-ended registration certificate," the association said.

The EBA said that in April 2016 a draft order by the Health Ministry appeared on its website that was to approve the new form for the open-ended registration certificate.

"Two months has passed since then and the draft order has not been approved," the EBA said.

The association asked acting Health Minister Viktor Shafransky to approve the form as soon as possible.