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Possible legislation amendments: Import of active pharmaceutical ingredients does not require the respective license

On December 19, 2014 for familiarization by the Verkhovna Rada of Ukraine the draft of the Law of Ukraine "On Amendments to certain Laws of Ukraine (concerning the abolition of import licensing for active pharmaceutical ingredients)" was submitted, which is expected to abolish import licensing for active pharmaceutical ingredients.

For this there is provided to amend by the Draft simultaneously two existing laws of Ukraine: the Law of Ukraine "On licensing of certain economic activities" and the Law of Ukraine "On Medicinal Products".

Recall that to date, the operation of the Order of the Ministry of Healthcare of Ukraine dated 20.02.2013 № 143 "On approval the license conditions of the economic activity on import of medicinal products" does not apply to the importation into Ukraine API and therefore for today requirements for import conditions APIs do not legally established.

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Dmytro Aleshko Managing partner, Attorney-at-law
Dmytro Aleshko
Andrii Gorbatenko Partner, Attorney-at-law
Andrii Gorbatenko
Vitalii Savchuk Partner, Attorney-at-law
Vitalii Savchuk
Lidiia Sanzharovska Associate Partner, PhD in Law
Lidiia Sanzharovska
Olexander Bondar Counsel
Olexander Bondar
Maryna Scherbak Senior Associate, Attorney-at-law
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Maryna Tkachenko Senior Associate
Maryna Tkachenko

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