On 20 April 2016 the Cabinet of Ministers of Ukraine adopted
Resolution No. 312 amending the Procedure for State Registration
(Registration Renewal) of Medicinal Products (the Procedure.) The
changes took effect on May 13.
In particular, Resolution No. 312 provides for the following
The regulation for the expert examination of registration
materials shall now be established by the Ministry of Health of
Ukraine (MoH) upon consultation with Ministry of Economic
Development and Trade of Ukraine (MEDT).
The maximum period for the expert examination of registration
materials for medicinal products already marketed in the US, the
EU, Switzerland, Japan, Australia or Canada has been limited to 20
business days. If the State Expert Center (the Center) does not
provide its conclusions and recommendations within the indicated
period, the expert examination shall be considered as carried
The period for the adoption by MoH of its decision authorizing
or refusing the registration of medicinal products has been
shortened from one month to 10 business days. Notably, this change
affects all medicinal products rather than only those marketed in
the jurisdictions above.
The adoption of these changes will help improve access of the
outlined medicinal products to the Ukrainian market. However, in
order to ensure proper implementation of the above changes, there
are still a few steps that need to be taken.
First, as it follows from the amended Procedure, MoH should
agree with MEDT the regulation for the expert examination of
registration materials. Such regulation should replace the existing
regulation approved by MoH's Order No. 426 and should reflect
the introduced simplifications.
Second, until the substitute regulation for the expert
examination of registration materials is adopted, it is not clear
whether the Center will in fact accept the new applications and, as
such, whether the expert examination shall nevertheless be
considered as carried out, thus resulting in MoH's
authorization of the registration of medicinal products. Therefore,
it is essential that the substitute regulation for the expert
examination of registration materials be adopted in order to enable
the Procedure to operate smoothly.
Third, the Procedure does not clearly stipulate that MOH should
issue its positive decision on the registration of medicinal
products in the absence of the Center's conclusions and
recommendations (e.g., the Center fails to provide same within the
established period). In our view, it would be reasonable to amend
the Procedure such that MoH does not have the discretion to make a
decision if the Center fails to provide its conclusions and
recommendations when due, regardless of the reason of such
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