The appointment of a Responsible Person is a mandatory requirement for lawfully placing cosmetic products on the Ukrainian market.
A Responsible Person is a legal or natural person resident in Ukraine who ensures compliance with the requirements of the Technical Regulation on Cosmetic Products in relation to a specific product.
The scope of responsibility includes, in particular, verification of the product composition, labelling and claimed properties, ensuring the availability of a safety report, preparation and maintenance of the Product Information File, confirmation of manufacturing compliance with GMP requirements, notification of the product and the graphic file of the labelling, as well as interaction with market surveillance authorities.
For cosmetic products manufactured in Ukraine, the Responsible Person is usually the manufacturer resident in Ukraine. For imported cosmetic products, each importer is the Responsible Person for the products they place on the market.
At the same time, the manufacturer or importer may appoint another legal or natural person resident in Ukraine to perform the functions of the Responsible Person.
Responsible Person Appointment Agreement
Pharma Navigation provides Responsible Person services for cosmetic products in Ukraine.
The appointment of Pharma Navigation as the Responsible Person is formalised under a Responsible Person Appointment Agreement. The agreement defines the scope of authority, rights and obligations of the parties, the procedure for transferring and updating documentation, communication timelines, interaction regarding requests from market surveillance authorities, complaints, undesirable effects and other matters related to the product’s presence on the Ukrainian market.
This approach allows the manufacturer or importer to transfer the regulatory support function to an independent specialised company, without appointing one of the distributors as the Responsible Person.
Confidentiality
All technical documentation provided by the manufacturer is treated as confidential and used solely for the purposes of regulatory assessment, notification, documentation maintenance and communication with competent authorities in Ukraine. Pharma Navigation signs a non-disclosure agreement (NDA) with the manufacturer to ensure an additional level of protection for confidential information. Documentation is not disclosed to distributors unless expressly authorised by the manufacturer.
What Is Included in the Functions of the Responsible Person
Within the scope of the service, Pharma Navigation provides:
- preparation, maintenance and updating of the Product Information File;
- regulatory assessment of the cosmetic product composition;
- review of labelling, claims and graphic packaging materials;
- control of the availability and completeness of the Cosmetic Product Safety Report;
- notification of product data to the competent authority;
- verification of documentary evidence confirming manufacturing compliance with GMP requirements;
- notification of the graphic file of the labelling and, where necessary, photographs of the packaging;
- ensuring the availability of documentation for the market surveillance authority;
- storage of product documentation for 10 years after the date on which the last batch of the product was placed on the market;
- support in cases of complaints, non-compliances, product withdrawal or recall;
- notification of the market surveillance authority about serious undesirable effects;
- provision of information on distributors upon request of the market surveillance authority;
- organisation of interaction with state authorities, market operators and consumers.
The name and address of the Responsible Person must be indicated on the labelling of each cosmetic product.
Liability for Product Non-Compliance
In case of non-compliance of cosmetic products with the established requirements, the market surveillance authority may require that the product be brought into compliance, withdrawn from the market or recalled.
The legislation also provides for administrative and economic sanctions, including:
- for placing on the market products that do not comply with the established requirements — from UAH 34,000 to UAH 51,000;
- for placing on the market products that pose a serious risk — UAH 102,000;
- for failure to comply with decisions of the market surveillance authority on restrictive or corrective measures — up to UAH 170,000;
- for obstructing inspections of product characteristics — UAH 170,000.
Sanctions may be imposed for each model, article or batch of products that are dangerous, pose a risk or do not comply with the established requirements, regardless of the number of units of such products or the number of points of sale.
Outsourcing the Responsible Person Function
Outsourcing the Responsible Person function allows you to:
- separate regulatory responsibility from commercial matters of supply and distribution;
- cooperate with several distributors without granting them full access to technical documentation;
- maintain control over confidential product information;
- have a single professional point of contact for matters of compliance, notification, documentation and interaction with market surveillance authorities.
Regulatory Support by Pharma Navigation
Pharma Navigation provides comprehensive support for cosmetic product notification, including:
- consultations on regulatory requirements;
- preparation of the product information file (PIF) and Cosmetic product safety report (or adaptation of existing documentation);
- ingredient and formulation assessment;
- designation of the Responsible Person;
- development of labelling and packaging design;
- submission of notification via the Ministry of Health portal;
- assessment of compliance with other applicable technical regulations.
Pharma Navigation approaches cosmetic product notification as a structured regulatory process, supporting projects both at the stage of initial documentation development and where existing PIF and CPSR require review or adaptation. Our practical experience, including direct cooperation with foreign manufacturers and professional communication in English, ensures accurate preparation and alignment of documentation with Ukrainian regulatory requirements.