On May 16, 2019, the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” (hereinafter – “the Law”) was published. The Law will enter into force on July 16, 2019, and transitional periods of 6 months have been set for a significant part of the provisions. The Law has […]

On April 9, 2019, the Resolution of the Cabinet of Ministers of Ukraine No. 296 came into force and approved amendments to the Resolution of the Cabinet of Ministers of Ukraine No. 376 of May 26, 2005 “On approval of the procedure for state registration (reregistration) of medicines and fees for their state registration (reregistration)” and to the Order […]

1. All medical devices that include radio equipment (Wi-Fi, Bluetooth, GPRS and other radio communication modules) must comply with the Technical Regulations of the radio equipment approved by Decree of Cabinet of Ministers of Ukraine No.355 as of May 24, 2017 and when placing on the market, must be accompanied with relevant Declaration of conformity. […]

On October 25, 2018, the Procedure for recognition of results of the other countries registration entered into force, approved by Decree of the Cabinet of Ministers of the Republic of Uzbekistan No. 862 dated October 24, 2018 “About approval of the Regulations on procedure for recognition of results of the registration of medicines conducted outside […]

From January 1, 2019, the symbols for use in the labeling of all products put into circulation in the territory of Ukraine, should be indicated in accordance with the Regulations, approved by the Order of the Ministry of Economic Development and Trade No. 914. Specifically, units of measurement should be indicated using those of the […]

We have issued digest regarding regulatory environment for medical devices in Ukraine: 1. Accreditation and designation of three conformity assessment bodies for medical devices has been cancelled in 2018: SE “SMCC”, SE “Cherkasystandartmetrolohiya”, “Politoks” LLC. We have summarised their stories and suggested specific actions for the manufacturer or it’s Authorised representative to be taken towards […]

In this digest you can find the most important news on issues of registration, safety management, and quality of medicinal products in post-soviet countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan for the first half of 2018: Open file in PDF   The highest activity has been observed in the Eurasian Economic Union (ЕАEU): […]

“Cratia Ltd” provides pharmacovigilance processes in Ukraine for variety of national and foreign pharmaceutical companies. In June 2018, “Ferrer”, an international medical product manufacturer, conducted GVP audit of processes that are being carried out for this company by “Cratia Ltd” in Ukraine. During the audit, it was confirmed that all pharmacovigilance processes for which “Cratia […]

On July 26, 2018 “Cratia”, took part in the business forum “Pharma & Cosmo Force”, where illuminated the subject on the regulation in the field of FMCG was developed. Evgenia Andrushchenko, director of business development of the company, presented her report related to the issues of “Regulatory requirements for the circulation of cosmeceutical products”. Natalia […]