Cosmetics Registration in Ukraine
Regulatory Authority:
Ministry of Health, Ukraine
Link for RA:
Local regulation:
The Technical Regulations for Cosmetic Products, approved by CMU Resolution No. 65 on January 20, 2021 (with an 18-month transition period), divided regulatory requirements into two periods:
- Until August 2, 2022, cosmetic product import and placement on the market is governed by Ukraine’s Law “On ensuring the sanitary and epidemiological well-being of the population,” which requires a sanitary-epidemiological certificate (hygienic certificate)
- From August 3, 2022, cosmetic products placed on the Ukrainian market must meet the Technical Regulations.
Who can register :
The responsible person is a resident entity or individual in Ukraine who ensures that the Technical Regulations are followed. A foreign producer must appoint a responsible person in Ukraine; the national manufacturer can be liable for his products or choose a third party.
Data to be communicated :
- List of products that will be imported in Ukraine;
- Catalogue with pictures of the products;
- A power of attorney in the name of ASAP Group (notarized or apostatized);
- Registration Certificate of the producer (or license for
- production – notarized or apostatized);
- Certificates of a quality control system (ISO 9001, GMP);
- Certificate of conformity to the directive of EU 76/768/EEC.
- Registration certificate for the product in the country of origin, and Free Sale certificate;
- List of the countries where the product is registered.
- The copy of the contract with the obligatory Specification in the appendix
- The letter from the producer that a product doesn’t contain components of medicine and genetically modified organisms.
- Quality: structure (INCI), Specification of a final product, certificates of quality and analysis of a final product.
- Safety and efficiency: results of the dermatological examination, toxicological reports, preclinical and clinical reports, scientific publications (or other similar documents);
- Artworks for primary and secondary packaging (including in electronic form – PDF or JPEG);
- Product samples
Process:
The Cosmetics registration procedure in Ukraine consists of two (2) main stages:
- Examination of the dossier for a cosmetic product
- Laboratory analysis of finished product sample & getting the SE conclusion
Issuing the conclusion and evaluation of the dossier are carried out by authorized expert organizations of the State Sanitary-Epidemiological Agency of the Ministry of Health of Ukraine.
The documents provided by Applicant to the Authority must comply with the current guidelines with no errors.
The Applicant (Holder) of marketing authorization may be any legal entity, resident or non-resident of Ukraine. The Applicant is not required to create a company in Ukraine.
The availability of a sanitary and epidemiological conclusion (SE conclusion) is a prerequisite for the import & sale of cosmetic products. To get an SE conclusion issued, it is mandatory to conduct a laboratory analysis. The SE conclusion confirms the quality and safety of products, determines the scope of implementation, and sets the safety criteria for the products.
The SE conclusion is issued for the first time in 2 years. After the end of that period, the Applicant is allowed to perform re-registration for the next three years. At the end of the conclusion, you must go through the entire procedure again.