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 changes:
- 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 out.
- 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 failure.
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