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 the Republic of Uzbekistan”.
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 International System of Units(SI), for example:
● мг - mg,
● мл - ml,
● Гц - Hz.
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 the conformity assessment certificate issued by mentioned bodies.
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:
On 27th June, 2018, an external audit of pharmacovigilance processes in Cratia Ltd has been conducted by Ferrer International.
“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.
On July 26, the business forum "Pharma & Cosmo Force" dedicated to issues of health, beauty and FMCG products was held
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 Kotovskaya, the head of the FMCG department, revealed key aspects of regulatory requirements for nutricosmetics, as well as the next changes in the legislative sphere.
Report on protection from falsified medical devices of the 7th Forum of Medical Device Operators, March 29, 2018
The market of medical devices in Ukraine is struggling from falsified products and “grey” import.
This situation slowly but methodically destroys the business of official representatives and importers, negatively affects the image of manufacturers, creates huge risks to the health of the nation.