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June 3, 2016
Introducing amendments into the Law of Ukraine “On Medicinal Products”

The Law “On Introducing Amendments into Article 9 of the Law of Ukraine “On Medicinal Products” concerning general simplifying of the state registration of medicinal products (Bill No. 4484 as revised with amendments of May 26, 2016) was adopted by the Verhovna Rada of Ukraine on May 31, 2016.

In accordance with the Law the simplified registration in Ukraine is applied to the medicinal products which are registered for use, produced and are also used in the countries having strict regulatory acts, namely USA, Canada, Australia, Japan, Switzerland and the European Union countries with centralized registration procedure for medicinal products. The term for approval of a decision on registration or refusal to register thereof is reduced by 10 working days.

Currently the request for the state registration shall be accompanied only with the materials as to the methods of medicinal product quality control, materials of the registration dossier, examples of the product package with marking, drug package leaflets, and a document confirming payment of the registration fee.

Moreover, it is stated, that instead of the certified copy of the document confirming compliance of the conditions for production of the filed medicinal product with the requirements of the current Ukrainian legislation, it is possible to file a written obligation of the manufacturer to deliver into Ukraine the medicinal product, which is manufactured on the same production facilities used in the USA, Switzerland, Japan, Australia, Canada or member-states or the European Union.


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