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Legal Alliance held a webinar concerning topical issues of application of medicinal product, which was re-registered

On December 18, 2014 lawyer of Legal Alliance Company Alexander Ianiev held a webinar about "Topical issues of application of medicinal product, which was re-registered"

As is known, on November 5, 2014 the pharmaceutical market of Ukraine received a nice gift from the legislator - unlimited period of application of medicinal product, which was re-registered. Also according to the provisions of the Law № 1707-VII, which established these innovations, medicinal products in Ukraine can be used until the expiration of shelf life, set by the producer and indicated on the package (if they were released into circulation in the period of approval for use these products in Ukraine)

Earlier in Ukraine it was mandatory re-registration of medicinal products every five years, and medicinal products with expired term of the registration certificate could not be realized on Ukrainian territory.

During the webinar, market participants received lawyer’s advice regarding the application of the new procedures, which has not received an official explanation of the regulator in general.

In particular, the speaker answered questions concerning the presence of current registration certificates, which confirm the fact of state re-registration and started re-registration state procedure of medicinal products. Mr. Ianiev discussed with the participants technical issues, related to the notifying in the registration certificate its duration, for those medicinal products, which were re-registered before the entry into force of the Law, as well as attempted state re-registration procedures until November 5, 2014.

"Still, it should be noted that the positive ideas of the Law №1707, are "half" in nature and are not adequately provide legal regulation in the sphere of state re-registration and circulation of medicinal products in Ukraine" - concluded Alexander.

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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