Notifying Member

_Ukraine_

Details of the notified legal text

_ 

Title

Law of Ukraine No. 4454 "On Amendments to Certain Laws of Ukraine Regarding the Implementation of the Bolar Provision" of 15 May 2025

Subject matter

Patents (including plant variety protection)_

Nature of notification

[X]     Main dedicated intellectual property law or regulation_

[  ]    Other law or regulation_

Link to legal text[*]

https://ip-documents.info/2025/IP/UKR/25_04214_00_e.pdf
https://ip-documents.info/2025/IP/UKR/25_04214_00_x.pdf

Notification status

[  ]    First notification

[X]     Amendment or revision to notified legal text

[  ]_    Replacement or consolidation of notified legal text(s)

Previous notification(s) referred to

IP/N/1/UKR/P/12; IP/N/1/UKR/P/5; IP/N/1/UKR/P/1; IP/N/1/UKR/1

Brief description of the notified legal text

_The Law provides for the possibility of submitting applications for the registration of generic medicines, as well as for their manufacture and storage in a warehouse, prior to the expiration of the relevant patent. It also sets out enforcement measures aimed at preventing the premature market entry of generics, in particular increased penalties for patent infringement.

Language(s) of notified legal text

English, Ukrainian

Entry into force

5 June 2025

Other date

Publication: 4 June 2025

Notification details

Submission date of notification

27 June 2025

Other information

https://zakon.rada.gov.ua/laws/show/4454-20#Text

Agency or authority responsible

Ministry of Health of Ukraine

Ministry of Economy of Ukraine