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Return of medical device inspections by market surveillance authorities in Ukraine: what should market operators prepare for?

11.10.2024

For more than four years, there were no market surveillance inspections concerning medical devices in Ukraine. Due to the COVID-19 pandemic, a ban on planned state market surveillance measures had been in place since March 2020, and in March 2022, a moratorium was introduced under Cabinet of Ministers Resolution No. 303 “On Suspension of State […]

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Updated procedure for notification of information on cosmetic products

11.08.2024

By the Order of the Ministry of Health of Ukraine dated July 19, 2024, No. 1264, amendments to the Procedure for notification (submission) of information on cosmetic products (hereinafter referred to as the Procedure), approved by the Ministry of Health of Ukraine on December 18, 2023, No. 2147, were approved. The Procedure defines the mechanism […]

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Technical regulation on the safety of chemical products (UA REACH)

09.08.2024

By the Resolution of the Cabinet of Ministers of Ukraine No. 847 dated July 23, 2024, the “Technical Regulation on the Safety of Chemical Products” was approved, which will come into effect on January 26, 2025. The regulation is based on Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). […]

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Technical regulation on cosmetic products and its requirements

07.08.2024

On August 3, 2024, the Technical Regulation on Cosmetic Products (hereinafter referred to as the Regulation), approved by the Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021 (hereinafter referred to as CMU Resolution No. 65), came into force. This is a regulatory legal act whose requirements are mandatory for […]

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Introduction of medical device registration in Azerbaijan from July 2024

06.08.2024

On July 19 and 20, 2024, the Cabinet of Ministers of the Republic of Azerbaijan adopted Resolutions No. 345 (introduction of state registration of medical devices and in-vitro diagnostic devices, new rules for the registration of medicines) and No. 347 (amendments to the procedure for the examination of medicines, medical devices, and in-vitro diagnostic devices). […]

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Approved methodological recommendations by the Ministry of Health on borderline products

22.07.2024

By Order of the Ministry of Health of Ukraine No. 1247 dated July 17, 2024, the methodological recommendations for the application of the Technical Regulation on cosmetic products concerning borderline groups of cosmetic products have been approved. The Technical Regulation defines a cosmetic product as “any substance or mixture intended for application to various external […]

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Regulatory newsletter for CIS and EAEU

01.07.2024

Dear сolleagues, In this digest, you will find the most important news on the registration, pharmacovigilance and quality control of medicines in Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine, Uzbekistan, and the Eurasian Economic Union (EAEU) which came into effect at the end of 2023 and the first half of 2024. In brief: […]

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Own brand in the dietary supplements market

12.06.2024

The Ukrainian and global dietary supplement markets are growing every year, and this trend will continue. The annual growth rate is forecasted to be over 9%, and by 2030, the global dietary supplements market will reach USD 327.42 billion[1]. The reasons for the increased consumption of dietary supplements include a focus on personal health, changes […]

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Private Label (PL) in the Cosmetics Market of Ukraine

22.05.2024

The use of Private Label (PL) in the cosmetics market, as in other consumer sectors, is a widespread phenomenon with a constantly growing share. Fashion houses, manufacturers of clothing and consumer goods, retail chains or pharmacies, celebrities, and even bloggers develop their own cosmetic brands. Production usually remains with a company that is not mentioned […]

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We professionally perform registration of medicines, conformity assessment of medical devices, certification of cosmetics, disinfectants and special food products in Ukraine.
Our partners, international corporations and national manufacturers can best tell about our expertise and quality of work. For more than 15 years of work we have performed works for:

  • more than 150 manufacturers of medicines and active substances,
  • more than 800 manufacturers of medical devices and equipment,
  • more than 300 manufacturers of special food products and cosmetics.
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