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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.
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