Ukraine Simplifies the Procedure for Registration of Medicinal Products

On 19 June 2016 the amendments to the Law of Ukraine "On Medicinal Products" became effective. These amendments, inter alia, simplify the procedure for state registration of medicinal products, which were previously registered by competent authority of a country with a stringent regulatory policy ("Country(ies)") for use within such a Country ("Medicine(s)"). Under the Law, the Countries include the United States, Switzerland, Japan, Australia, Canada, as well as the EU member states, provided, however, that the Medicines were registered by the EU competent authority under the centralized procedure.

The amendments are intended to simplify the procedure for state registration of the Medicines and, among other things, provide for the following:

• fewer documents needed to register the Medicines (the list of required documents no longer includes materials of preclinical studies and clinical trials, as well as certain other documents);
• a decision on the state registration to be made within up to seven business days (instead of one month according to the previous procedure). The amendments also envisage that the master file of a Medicine, which was filed with the regulatory authority that registered the Medicine, shall not be subject to examination. Moreover, the amendments have shortened the term for review of the materials submitted to register a Medicine to ten business days (previously, the examination of the registration materials was to be completed within twenty business days);
• possibility to file, instead of a copy of GMP compliance certificate or opinion, a manufacturer's written undertaking to produce the Medicines for Ukraine on the same manufacturing facilities that are intended for manufacturing for the Country's domestic market.

Furthermore, the amendments provide for the list of grounds to deny registration of a Medicine. Such grounds include the following: incomplete set of documents filed for the state registration of a Medicine; unreliable or incomplete information in the filed documents; a discrepancy in the name of manufacturer, its address or the address of its manufacturing facilities specified in the application for state registration of a Medicine, as compared to the information, based on which the competent authority of a Country registered the Medicine.

Also, some of the amendments relate to the procedure for state registration of all other medicinal products. Specifically, the amendments provide for:

• the term for making a decision on state registration of a medicinal product reduced to ten business days (instead of one month);
• the information on applications for state registration of medicinal products, status of review of the filings and the approved decisions to be made public online;
• the State Register of Medicinal Products to include information on prior registration, re-registration, and cancellation of registration of a medicinal product, as well as its registration by the competent authority of a Country for use with the Country's territory.

For further information please contact Asters' partner Svitlana Chepurna
and associate Inesa Letych.