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State Administration on Medicinal Products or Court: Who shall have the last Word in the Sphere of Manufacturing and Distribution Termination of Medicinal Products?

On 25.09.2015 Verkhovna Rada of Ukraine registered the Draft Law on Amendments Introduction to Article 15 of the Law of Ukraine "On Medicinal Products". This draft law provides for brining into compliance with the Law of Ukraine «On Main Principles of State Monitoring (Control) of Economic Activity» the authorities of State Administration on Medicinal Products officials, in particular the draft law designates that the production (manufacturing) and distribution of medicinal products may be suspended only by the court decision.

It is worth to mention that currently the relevant decisions are made by State Administration on Medicinal Products which is in direct contradiction to part 5, article 4 of the abovementioned Law with regard to which the production (manufacturing) and distribution of products by business entities may be suspended exclusively by court decision.

An undeniable advantage of the draft law adoption shall be the mutual harmonization of acting Laws of Ukraine «On Medicinal Products» and «On Main Principles of State Monitoring (Control) of Economic Activity».

Moreover, with this draft law adoption it is expected that the regulatory burden on business entities will be eased.

At the same time, please note that in case of suspension of production and distribution of medicinal products through the court proceeding there is a risk of increase of disposition and decision making time.

Our Team

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
Maryna Scherbak
Maryna Tkachenko Senior Associate
Maryna Tkachenko

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