Join us at this years Regulatory Affairs Summit in Prague, 24-26 October, 2017October 06, 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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eSubmissions Course, 6 - 7 April 2017, Riga, LatviaApril 10, 2017
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