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Parliament adopted the Law on simplified registration of medicinal products being registered in the countries with the strict regulatory policy

On May 31, 2016, Verkhovna Rada of Ukraine adopted as it is the Draft Law of Ukraine "On Amendments to the Article 9 of the Law of Ukraine "On Medicinal Products" regarding the Simplification of Medicinal Products Registration" (Reg. № 4484).

The Law provides for the simplified registration of medicinal products being registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada, and the European Union in accordance with the centralized procedure. Such products should be accepted for usage in the territories of the mentioned countries or the EU member-states.

The registration procedure for such medicinal products envisages the submission of the smaller package of documents, reduction of registration terms (17 business days), and no need for the expertize of the registration materials.

The final version of the Law shall be available to public in the nearest future.

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