The Parliament of Ukraine has recently adopted Law No. 3998-VI, introducing new rules to the Law of Ukraine on Pharmaceutical Products No. 123/96-ВР regarding data exclusivity protection of the original (innovative) pharmaceutical products registered in Ukraine.

With these changes, the mechanism of data exclusivity protection provided for original (innovative) pharmaceutical products registered in Ukraine becomes more closely aligned with international standards.

According to amendments introduced by the Law No. 3998-VI, registration (i.e. marketing authorisation) of generic pharmaceutical products in Ukraine is permitted only  five years after the original (innovative) product, containing the same active ingredient as a generic product, was registered in Ukraine on the basis of the full registration dossier. This data exclusivity period shall not apply if an applicant for generic registration (i) has been duly authorised to refer to or use information from the registration dossier of the original, or (ii) submitted its own full registration dossier.

The new changes provide for extending data exclusivity periods for up to six years if during the first three years after the original's registration competent state authorities permitted its use according to one or more indications that are especially advantageous compared to the existing ones.  Rules and criteria for determination of such advantageous indications are yet to be elaborated by the Health Protection Ministry of Ukraine.

The data exclusivity period applies only with respect to those original (innovative) pharmaceutical products for which applications for registration in Ukraine were submitted not later than two years after initial registration in any other country.

Changes envisaged by the Law No. 3998-VI become effective from the date of its official publication which is expected shortly.

Law: Law of Ukraine No. 3998-VI of 03 November 2011 "On Introducing Changes into Article 9 of Law of Ukraine on Pharmaceutical Products".

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The original publication date for this article was 01/12/2011.