The Responsible Person is a legal entity or an individual resident of Ukraine who ensures that a cosmetic product complies with the requirements of the Technical Regulation. This includes conformity of composition, labeling, compliance with Good Manufacturing Practices (GMP), preparation of the safety assessment report, product notification and product labeling, maintenance and updating of the Product Information File (PIF), and monitoring of undesirable effects. Only cosmetic products with an appointed responsible person may be placed on the market in Ukraine.
In the case of cosmetics manufactured in Ukraine, the responsible person is the manufacturer. If the product is imported, this role is performed by the importer. At the same time, both the manufacturer and the importer may delegate the responsibilities of the responsible person to a third party, provided that a written mandate is issued and written consent is obtained from the authorized person.
Beauty Compliance Solutions specializes in outsourcing the functions of the responsible person for cosmetic manufacturers. Cooperation with us allows for:
- High-quality conformity assessment of products, enhancing their safety;
- Separation of regulatory processes from marketing and sales activities;
- Centralized storage of the Product Information File with increased confidentiality;
- Professional management of interactions with government authorities, including market surveillance inspections;
- Improvement of the process of collecting product safety data.
The functions of the responsible person include:
- Ensuring that the product’s composition complies with applicable requirements;
- Verifying the accuracy and legality of labeling;
- Preparing the product safety assessment report;
- Creating and continuously updating the technical documentation;
- Organizing sample collection and laboratory analysis;
- Ensuring GMP standards are followed during production;
- Submitting product and packaging notifications to the competent authorities;
- Storing documentation for 10 years after the last batch is withdrawn from the market;
- Ensuring open access to product composition information;
- Providing data about distributors upon request from market surveillance authorities;
- Reporting serious adverse reactions related to the use of the product.