Decree of CMU from 18.03.2015 № 125

On March 23 the government portal has published Decree of CMU from 18.03.2015 № 125 “On Amendments to the Procedure for state registration (renewal) of medicinal products”. The document will come into force after publication in the official media.

The order of state registration (renewal) of medicinal products (hereinafter – the Procedure) was approved by the Decree of Cabinet of Ministers on 26.08.2005 № 376.

As was already reported, Decree of CMU № 125 will implement the Law of Ukraine from 12.08.2014, № 1637-VII «On Amendments to the Law of Ukraine” On Medicines “on the improvement of the order of providing the population with medicines intended for the treatment of socially dangerous and heavy diseases” and the Law of Ukraine of 10.20.2014, № 1707-VII« On Amendments to the Law of Ukraine “On Medicines” regarding the treatment of drugs and state quality control of drugs imported into the customs territory of Ukraine.”

Adopted Decree of Cabinet of Ministers № 125 provides for the cancelation of repeated renewal of medicines. Thus, after the renewal – the validation period of MA for the drug in Ukraine will not be limited.

Adopted amendments also simplify the state registration of drugs intended solely for the treatment of tuberculosis, HIV/AIDS, viral hepatitis, cancer and rare (orphan) diseases that are registered with the competent authorities of the United States, Switzerland, Japan, Australia, Canada or the EU as a drug.

Decision on registration or refusal of registration of such drugs will be taken care by the Ministry of Health of Ukraine, within seven days after receipt of the conclusion on expertise of materials. The exception is specified in the list of grounds for a decision on full or temporary prohibition of the use of the drug by the termination of the registration certificate.

Market participants, in turn, repeatedly stated that the amendments to the Decree of CMU №376 is not enough for the full implementation of the Law of Ukraine № 1707-VII, which also leads to the need for changes in the Order of MOH of Ukraine from 26.08.2005 № 426 “On Approval of the Procedure of examination of materials for medicinal products submitted for state registration (renewal), as well as the examination of materials on amendments to the registration materials during the registration certificate. “