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Imported medicines registration term in Ukraine will be cut to 10 days

Imported medicines registration term in Ukraine will be cut to 10 daysUkraine's Cabinet of Ministers 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 days," acting Health Minister of Ukraine Ulana Suprun said.

The government backed the proposal of Deputy Prime Minister and Economic Development and Trade Minister Stepan Kybiv 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 Verkhovna 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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