Ukrainian government simplifies registration of medicines from the U.S., EU and certain other developed countries January 16, 2017

Ukrainian government simplifies registration of medicines from the U.S., EU and certain other developed countries

On June 16, 2016, the President of Ukraine signed the Amendments to the Medicines Act, which are intended to simplify the procedure of state registration of medicines coming from countries with strong established regulatory requirements, institutions, and procedures. The changes will become effective starting from their official publication day and responsible government agencies must still adjust certain bylaws to implement them.

Extended list of medicines subject to the simplified procedure

Now all medicines (drugs) registered by a competent authority of the USA (i.e., FDA), Switzerland, Canada, Australia, Japan, and the EU are now subject to the simplified registration procedure. Whereas the previous version of the Medicines Act allowed such simplified procedures only for medicines that treat tuberculosis, HIV/AIDS, viral hepatitis, oncological, and rare (orphan) illnesses.
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Reference to Order of Ministry of Health Care UA