Responsible person in Ukraine
This section of the website applies to requirements of the Technical regulations on cosmetic products that will become effective from August 3, 2022. For earlier requirements please refer to the following page.
Only those cosmetic products for which a Responsible Person (RP) has been designated can be placed on the Ukrainian market.
The Responsible Person can be a resident entity or a resident individual of Ukraine: manufacturer, importer, distributor, third party (authorized representative).
A foreign manufacturer is obliged to designate a responsible person in Ukraine. The national manufacturer is himself the responsible person for his products, or he can designate a third party.
The designation of a responsible person is performed by the Power of Attorney and requires the written consent of the RP.
Cratia provides professional outsourcing of the functions of a responsible person for manufacturers of cosmetic products. Cooperation with us will allow to:
Agreement and Power of Attorney
The designation of a responsible person is carried out in writing by a Power of Attorney. The Power of Attorney must be properly legalized.
In addition to the Power of Attorney, an Agreement can be signed between the manufacturer and the responsible person, which more fully regulates the rights and obligations of both parties, establishes the terms of communication, the procedure for dealing with complaints, and reports on adverse event and many other aspects.
Our legal department has developed exclusive drafts of the Power of Attorney and the Agreement for the appointment of a Responsible Person in Ukraine. We constantly monitor updates and respond in time to key comments from customs, market surveillance bodies and competent authorities.
Obligations and Responsibilities
The responsible person ensures that the requirements of the Technical Regulations for cosmetic products are met and is responsible for their compliance.
The responsibilities of the responsible person include:
- ensuring that the product safety assessment has been performed and a safety report is available;
- ensuring of the manufacture compliance with GMP requirements;
- notification of product data to the competent authority;
- notification (registration) of mock-ups;
- compliance with the requirements for sampling and product analysis;
- ensuring the conformity of product labeling with the requirements of technical regulations;
- storing product information file (PIF) and ensuring its availability for the market surveillance body for 10 years after the date of the last lot of products being introduced;
- ensuring public access to information on the ingredients and quantities of the product;
- providing information about the distributors at the request of the market surveillance body;
- notifying the market surveillance body of serious undesirable effects;
- taking reasonable actions in case of non-conformity of a cosmetic product (bringing to conformity, recall from the market, recall from sale);
- interaction with various state agencies, operators of the cosmetic market and consumers in various other situations.
The name and address of the responsible person must be indicated on the labeling of each cosmetic product.
Penalty charges established by Article 44 of the Law of Ukraine “On State Market Supervision and Control of Non-Food Products”:
- Introduction of products that do not meet the established requirements – UAH 51,000.
- Introduction of products posing a serious risk – UAH 102,000.
- Failure to comply or incomplete implementation of the decision to take restrictive (corrective) actions in relation to products posing a serious risk – UAH 170,000.
- Failure to comply or incomplete implementation of the decision to take restrictive (corrective) actions in relation to other products – UAH 102,000.
- Obstructing by preventing examinations of product characteristics – UAH 170,000.
Penalty charges are imposed for each type, article or lot of products that are hazardous, pose a risk and/or do not meet the established requirements, regardless of the number of units of such products and/or places of sale.
Responsible Person Outsourcing Services
Cratia offers the service of a Responsible person in Ukraine. This allows:
- professional management of the regulatory and safety issues;
- to separate regulatory compliance from the supply chain and commercial issues;
- to cooperate with several distributors at the same time, without designating any of them as a responsible person;
- to increase the confidentiality of documentation;
- to improve the safety monitoring.
We specialize in performing the functions of the Responsible Person, have excellent knowledge of Ukrainian and European legislation, have a large and well-coordinated team of professionals, broad experience in conformity assessment and related areas.
Cratia provides comprehensive regulatory support and accompanies at all stages of regulatory compliance of cosmetic products in Ukraine:
- outsourcing of a Responsible Person (RP) in Ukraine;
- assessment of the composition of the product;
- filling of the Product Information File;
- Cosmetic Product Safety Report (CPSR);
- verification/development of labeling, instructions, and advertising materials;
- product notification;
- development and implementation of Good Manufacturing Practice in accordance with ISO 22716 (GMP);
- legal and consulting support of the manufacturer, Responsible person or distributor (importer).
We possess deep knowledge and experience, speak and write fluent English. We will take over the organization of the process, assist in filling of the set of documents and perform the required procedures in a short time.