Ukraine. Amendments to the Procedure of Registration and Re-registration of Medicines (Draft)

[March 25th, 2014] The MHU released for public discussion the draft of the Regulation of the CMU “On Amendments to the Procedure of Registration (Re-registration) of Medicines” (the “Draft”). The Draft envisages that after re-registration the medicines can be used in Ukraine for an unrestricted period of time with the exception of cases when the MHU makes a decision within the due procedure about full or partial restriction of the medicines through the cancellation of the registration certificate.

The decision on the prohibition of use of certain medicines may be made if dangerous qualities of the medicines which were not known before are discovered (inter alia, if the formula does not comply with the registration documents or such medicines can harm human health).

In addition, the Draft provides that the registration of medicines shall be performed by the MHU on the grounds of application for the state registration of the medicines, registration materials and the records of the European Medicines Agency (the “EMA”) registration profile should such medicines be registered at the EMA and if the original medicines are not included into the State Registrar of Medicines of Ukraine.

Simplified procedure of registration of medicines which are already registered by the EMA according to the centralized procedure is also prescribed by the Draft Regulation “On Amendments to Paragraph 2 of the Procedure of State Registration (Re-registration) of Medicines”.

Source: KPMG Ukraine