Ukrainian Ministry of Healthcare changes authorization process for medicinal products
Egorov Puginsky Afanasiev & Partners,
Kyiv, Ukraine, Tue, Nov 10, 2015
Kyiv, Ukraine, Tue, Nov 10, 2015
With effect from 30October 2015, a new order of the Ministry of Healthcare of Ukraine (the “Order”)introduced a number of significant changes to Ukrainian drug review andauthorization process.
Core simplifications ofdrug registration
Most notably, the Orderis expected to finally bring to life important regulatory simplifications thatwere approved by Ukrainian Parliament back in 2014, but remained inoperativedue to lack of required secondary legislation. These include the following:
cancellation of every 5-year re-registration forfinished medicinal products. Going forward, on the first successful renewal ofa marketing authorization (“MA”), it can get an unlimited validity.Another 5-year expiry can be given to MA as an exception, in case there arepharmacovigilance concerns. At the same time, the Order does not establish aclear mechanism for transition to the new MA renewal system. Accordingly, atthis stage, it is not entirely clear to what extent new provisions concerningMA unlimited renewal would apply to products registered under previouslyeffective procedures;
new special expedited process is established as anoption for granting of MAs to medicinal products intended exclusively fortreatment of tuberculosis, HIV/AIDS, virus hepatitis, oncology, orphan diseasesand registered by the competent authority of the U.S., Switzerland, Japan, Australia,Canada or the EU. Such process involves a very limited documentation check andshould take no more than 7 business days. It should be noted, however, that thespecial process applies to initial product registration only. Accordingly,renewal of MAs, as well as any variations, will most likely require goingthrough the general authorization procedure, which may reduce theattractiveness of special process for pharmaceutical companies.
The MA holders shouldnote that the Order also introduced a number of other changes to the drugregistration process, in terms of its stages, timelines, scope and forms ofdocumentation etc. Among other things, the Order:
streamlines the general authorization process formedicinal products approved by the EMA under centralized procedure; severaltypes of WHO prequalified drugs (HIV/AIDS, tuberculosis, vaccines, toxoids); aswell as certain original (innovative) products (tuberculosis, HIV/AIDS, virushepatitis, oncological and orphan diseases) registered in the U.S.,Switzerland, Japan, UK and Australia;
establishes rather detailed requirements toapplications for transfer of MAs from one entity to another, thus closing a gapthat existed in previously effective regulations;
clarifies that, in order to prevent issuance of an MA,patent infringement has to be confirmed by a court judgement that has enteredinto force. Copy of such judgement should be provided to the MOH and its expertinstitution. This clarification closes the legal ambiguity in this respect andis generally supported by prevailing market practice;
arguably permits pharmaceutical companies to not onlyconduct R&D, but also file the registration dossier of a generic medicinalproduct before expiry of the reference product 5-year data exclusivity period,in order to obtain the MA after the exclusivity expires. This rule is, however,rather ambiguous and may require additional clarifications from the regulator.