The European Business Association (EBA) has called on harmonizing Ukrainian legislation in the field of medical drug registration with the EU legislation.
According to a press release of the EBA Health Care Committee, referring to experts in the sphere of medical drug registration, the procedures that launched in the EU countries are not implemented in the legislation of Ukraine.
According to the experts, it is necessary to improve and introduce European practices into the evaluation procedure (Health Ministry resolution No. 426 dated August 26, 2005) – the basic document regulating the evaluation of registration materials.
According to the association, the Health Ministry plans to hold a meeting in April 2019 and discuss a number of changes to the evaluation procedure.
The EBA said that it is necessary to make changes to the registration of materials during the re-registration, which will eliminate the risks of forced delays in the evaluation of registration documents for medicines.
The experts also call for grouping changes in registration materials for one or more registration certificates issued to one applicant. The introduction of this practice, which is already used in EU member states, will help optimize resources, both of the expert body and the applicants.
The association said that the implementation of the Do & Tell procedure is also considered necessary. This procedure involves first the physical embodiment of the changes by the manufacturer, and then the submission of an application to the State Evaluation Center of the Health Ministry.
