Registration of healthcare products in Ukraine

We professionally perform registration of medicines and API’s, conformity assessment of medical devices, certification of cosmetic products, biocides and special food products in Ukraine

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Conformity assessment of medical devices Registration of medicines, pharmacovigilance and GMP Technical regulation on cosmetic products Registration of disinfectants (biocides) in Ukraine

We are recognized experts in regulatory matters for medical products, quality and competence are certified by Bureu Veritas (Italy) in accordance with ISO 9001:2015. Our success is based on an excellent team of professionals, each of whom is an expert in his field and constantly improves his knowledge and skills.

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Key changes in the regulation of medicines in Ukraine

17.10.2024

In recent months, several legislative acts have been adopted that significantly affect the regulation of medicinal products, specifically: A ban on advertising information on the labeling and information about persons other than the Manufacturer and MAH (marketing authorization holder), which comes into effect on January 18, 2025; Parallel import of medicines purchased by an authority […]

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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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We are trusted by more than 1200 clients

Our partners, international corporations, national manufacturers and distributors can tell the best about our professionalism and quality of work. For each Customer, we try to choose the optimal relationship scheme, paying equal attention to both large customers and small orders.

Almost always, the company becomes our permanent and long-term partner. Our portfolio includes: