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    • Cosmetic products Compliance in Ukraine

    Under the Technical Regulation on Cosmetic Products, approved by Resolution of the Cabinet of Ministers of Ukraine No. 65 of 20 January 2021 and harmonized with Regulation (EC) No. 1223/2009, a cosmetic product may be placed on the Ukrainian market only if a Responsible Person resident in Ukraine has been designated for it. From 3 August 2026, upon expiry of the transitional period, this requirement applies to every cosmetic product placed on the market for the first time, without exception.

    For foreign manufacturers and brand owners without a legal presence in Ukraine, IPR Group acts as the Responsible Person of record, serving as your authorized and trusted representative before the Ukrainian regulatory authorities.

    The Responsible Person is the legal face of the product on the Ukrainian market. The RP guarantees, for each product, conformity with the Technical Regulation and serves as the single point of contact for the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drugs Control, the market surveillance authority. The RP mandate is established by a written appointment accepted by the RP in writing and is maintained separately for each product.

    We provides the following services on the matter:

    • Responsible Person of record. We assume the statutory role of RP for your products, maintain a Ukrainian address of record for the authorities, and act as your trusted representative in all dealings with the regulator.
    • Responding to market surveillance requests. We receive and respond, within the statutory time limits, to requests, inquiries, and correspondence from the State Service of Ukraine on Medicines and Drugs Control relating to each product.
    • Product Information File (PIF) custody and maintenance. We compile, maintain, and update the full technical dossier, including the product description, specifications, test protocols, GMP evidence, CPSR, labelling and packaging artwork, and declaration of conformity. The file is kept available for inspection for 10 years after the last batch of the product has been placed on the market.
    • Electronic product notification. We register your entity in the electronic notification system of the Ministry of Health, complete the product entries, including the category, frame formulation, composition, manufacturer and RP details, upload the original labelling artwork, and complete the notification before the product is placed on the market.
    • Composition and labelling review. We review the formulation against the prohibited, restricted, and permitted substance lists contained in Annexes 2 to 6 of the Technical Regulation and verify that the label complies with all mandatory requirements, including Ukrainian language information, the INCI ingredient list, and the batch number.
    • Cosmetic Product Safety Report (CPSR). We arrange the preparation of the CPSR (Part A, Safety Information; Part B, Safety Assessment), signed by a qualified safety assessor, or, where an EU format CPSR already exists, its adaptation to the Ukrainian regulatory framework.
    • GMP compliance verification. We review the manufacturer’s GMP evidence, including certificates or audit reports, to verify conformity with the standard identical to ISO 22716, which is a prerequisite for maintaining a complete PIF.
    • Serious undesirable effects and corrective measures. We notify the competent authority of any serious undesirable effects and cooperate with the authorities regarding any corrective measures, withdrawals, or recalls that may be required.
    • Translation into Ukrainian. We translate documentation and labelling as required for the PIF, electronic notification, and market surveillance purposes.

    Who requires a Responsible Person in Ukraine?

    • Foreign manufacturers and brand owners exporting cosmetic products to Ukraine without a resident legal entity.
    • EU companies whose products already have complete EU dossiers, in which case Ukrainian compliance is largely limited to the adaptation and translation of existing documentation.
    • Importers and distributors wishing to transfer the compliance burden to a professional representative under a written mandate.

    Should you have any questions or wish to request a quotation, please contact us at regulations@iprgroup.info.