Two medicine registration certificates effective at the same time: how to produce and trade in the medicine?

On March 5^th, 2019 the State Service of Ukraine on Medicines and Drugs Control on its official website placed explanation for commercial entities engaged in trade in medicines on legitimacy of effectiveness of two registration certificates and other registration documents for one medicine in case of its early re-registration.

Thus, under Article 9(9) of the Law of Ukraine “On Medicines”, decision on state registration confirms the pharmacopoeia article or quality control methods, approves technical regulation or data on production technology, and assigns a number entered to the State Register of Medicines of Ukraine to the medicine.

Besides, under paragraph 6 of the Procedure for Registration (Re-Registration) of Medicines approved by Resolution of the Cabinet of Ministers of Ukraine No. 376 as of May 26^th, 2005, state registration of a medicine is certified by the registration certificate for such a medicine which sets the term during which its use on the territory of Ukraine is allowed.

Taking into consideration that at re-registration of a medicine updated registration file can be approved, commercial entities trading in medicine had questions whether production of the medicine should be brought in line with the registration file updated and approved at the additional re-registration.

Given this, the State Service on Medicines and Drugs Control has reported that the current legislation of Ukraine does not contain any norm which would provide for termination of registration certificate due to early medicine re-registration. Therefore, its use is allowed for the term specified in such a registration certificate.

Hence, manufacturer/applicant is not obliged to bring the production in line with the registration file updated and approved at the additional re-registration before their expiry. Such adjustment of production is carried only if the commercial entity wishes so.