Ukraine's Cabinet of Ministers
at a Monday meeting approved a draft resolution facilitating the registration
of imported medicines in Ukraine and narrowing it to 10 days.
"The adoption of the
draft resolution would help to improve the registration of medicines in
Ukraine: it will help to relax the registration of medicines that had been
registered by authorized agencies of the United States, Switzerland, Japan,
Australia, Canada and the European Union and cut the term for decision making
to 10 day," acting Health Minister of Ukraine Ulana Suprun said.
The government backed the
proposal of Deputy Prime Minister and Economic Development and Trade Minister
Stepan Kubiv to revise the clause of the document that requires having the
conclusions of the expert department of the Health Ministry for the
registration of medicines. The conclusions are internal documents of the
ministry.
He added that according to
bill No. 4484 passed by Ukraine's Verkhova Rada facilitating the registration
of medicines produced and used in countries with strong regulatory practices,
four documents are required from the applicants: materials on methods for
controlling the quality of medicines, materials of the registration dossier,
examples of packages and its labeling and the document confirming the payment
of the registration fee.
Ukrainian Prime Minister
Volodymyr Groysman said that the facilitation of the registration of imported
medicines in Ukraine would reduce prices of medicines.
"The bill has been
passed, and our task is to approve all the required government decisions so
that high-quality medicines can enter Ukraine. I ask profile ministries to take
the issue under personal control, as I know that there would be attempts to
sabotage it. It is important for us that Ukrainians receive a wide range of
high-quality medicines and the price is cut. I am sure that in coming months
this would happen," Groysman said.
The Verkhovna Rada on May 31,
2016 approved a bill facilitating the registration of medicines produced and
used in countries with strong regulatory practices.
The simplified registration
applies to the medicines made and used in the countries with strong regulatory
authorities: the United States, Canada, Australia, Japan, Switzerland and the
European Union. The term for registering these medicines is reduced to 10
working days.
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