With effect from 30 October 2015, a new order of the Ministry of Healthcare of Ukraine[1] (the “Order”) introduced a number of significant changes to Ukrainian drug review and authorization process.

Core simplifications of drug registration

Most notably, the Order is expected to finally bring to life important regulatory simplifications that were approved by Ukrainian Parliament back in 2014, but remained inoperative due to lack of required secondary legislation. These include the following:

• cancellation of every 5-year re-registration for finished medicinal products. Going forward, on the first successful renewal of a marketing authorization (“MA”), it can get an unlimited validity. Another 5-year expiry can be given to MA as an exception, in case there are pharmacovigilance concerns. At the same time, the Order does not establish a clear mechanism for transition to the new MA renewal system. Accordingly, at this stage, it is not entirely clear to what extent new provisions concerning MA unlimited renewal would apply to products registered under previously effective procedures;

• new special expedited process is established as an option for granting of MAs to medicinal products intended exclusively for treatment of tuberculosis, HIV/AIDS, virus hepatitis, oncology, orphan diseases and registered by the competent authority of the U.S., Switzerland, Japan, Australia, Canada or the EU. Such process involves a very limited documentation check and should take no more than 7 business days. It should be noted, however, that the special process applies to initial product registration only. Accordingly, renewal of MAs, as well as any variations, will most likely require going through the general authorization procedure, which may reduce the attractiveness of special process for pharmaceutical companies.

Other modifications

The MA holders should note that the Order also introduced a number of other changes to the drug registration process, in terms of its stages, timelines, scope and forms of documentation etc. Among other things, the Order:

• streamlines the general authorization process for medicinal products approved by the EMA under centralized procedure; several types of WHO prequalified drugs (HIV/AIDS, tuberculosis, vaccines, toxoids); as well as certain original (innovative) products (tuberculosis, HIV/AIDS, virus hepatitis, oncological and orphan diseases) registered in the U.S., Switzerland, Japan, UK and Australia;

• establishes rather detailed requirements to applications for transfer of MAs from one entity to another, thus closing a gap that 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 entered into force. Copy of such judgement should be provided to the MOH and its expert institution. This clarification closes the legal ambiguity in this respect and is generally supported by prevailing market practice;

• arguably permits pharmaceutical companies to not only conduct R&D, but also file the registration dossier of a generic medicinal product 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.