REGISTRATION

Registration / Re-registration / Variations of the Registration Dossier

The sale of pharmaceutical products on the territory of Ukraine is only possible after their registration. The process of registration pharmaceutical products is always very costly and time-consuming, that’s why use of professional services is strongly recommended with a professional approach, careful examination of the supporting documents and accurate completion of registration dossiers in accordance with the legislation. It is important to consider the relation of the manufacturer’s country to the PIC/S countries, because during registration of pharmaceutical products it is necessary to provide validation of GMP certificate. If such certificate is not available, it is necessary to undergo an audit and inspection of the manufacturing site.

Legal Support of Imported Beauty & Personal Care Products

Legalization of imported beauty products can be conducted similar to a pharmaceutical product if it has medicinal qualities. If beauty products don’t belong to the category of pharmaceutical products, it is necessary to obtain the Conclusion of the sanitary-epidemiological expertise for their legalization in the territory of Ukraine. Sanitary and Epidemiological Conclusion is a document confirming that that the products underwent a qualified sanitary-hygienic inspection and comply with all sanitary rules and norms of Ukraine. Sanitary and Epidemiological Conclusion as well as the report confirm the safety of products for the health and life of citizens and the environment.

Certification of Medical Devices

The market of medical devices and medical equipment is one of the most developed branches of the global industry. In addition, because Ukraine chose European course of development, there is an increasing number of technical regulations, which regulate the sector of medical devices among other things. Their primary function is to improve quality of life and increase life expectancy. This market is under constant surveillance of regulating authorities. Our goal is to help our customers to achieve their goals in the best possible way, to provide guidance in a dynamic regulatory policy and an active position concerning the protection of market interests in the public authorities.

Legal Support of Dietary Supplements, Baby Food

Legalization of dietary supplements and functional baby food requires carrying out a procedure for obtaining certain documents that allow the import and sale of these products in the territory of Ukraine. Importers must have an international quality certificate issued by the competent authority in the manufacturer’s country, which confirms the safety of the products. If the Customer plans to start production in Ukraine, it is necessary to obtain conclusions of laboratory testing concerning products safety and to determine the category of the product.