Registration of pharmaceutical products

State registration of medicinal products in Ukraine is regulated by a number of regulatory legal acts that establish requirements and procedures to ensure the quality, safety, and efficacy of medicines.

The main regulatory acts:

The Law of Ukraine "On Medicinal Products": defines the general provisions regarding the circulation of medicinal products, including the requirements for their state registration.

Resolution of the Cabinet of Ministers of Ukraine dated May 26, 2005, No. 376: approves the "Procedure for State Registration (Re-registration) of Medicinal Products," which establishes the mechanism for conducting state registration and re-registration of medicinal products, as well as the fees for these procedures.

Order of the Ministry of Health of Ukraine dated July 23, 2015, No. 460: approves the "Procedure for Conducting Expertise of Registration Materials for Medicinal Products" submitted for state registration (re-registration), defining the procedure for the examination of registration materials.

The main stages of state registration of medicinal products:

Submission of the application: The applicant submits an application for the state registration of a medicinal product to the Ministry of Health of Ukraine, along with the registration dossier containing information on the quality, safety, and efficacy of the drug.

Expertise of registration materials: The State Expert Center of the Ministry of Health of Ukraine conducts an examination of the submitted materials, including verification of compliance with Good Manufacturing Practice (GMP) requirements and an assessment of the benefit-risk ratio of the medicinal product.

Decision on registration: Based on the results of the examination, the Ministry of Health of Ukraine makes a decision on the state registration of the medicinal product and issues a registration certificate.

Entry into the State Register of Medicinal Products of Ukraine: The registered medicinal product is included in the State Register of Medicinal Products of Ukraine, which allows for its legal production, import, and sale within the country.

Requirements for the registration dossier:

The registration dossier must include the following main sections:

Administrative data: Information about the applicant, manufacturer, name of the medicinal product, dosage form, composition, and other relevant details.

Quality documentation: Data on production, quality control, specifications for raw materials and finished products.

Preclinical studies: Results of pharmacological and toxicological studies.

Clinical studies: Data on the clinical efficacy and safety of the medicinal product.

Obligations of registration certificate holders:

After receiving the registration certificate, the holder is obliged to:

Provide the state control authority with information about completed clinical studies.

Ensure that production conditions comply with Good Manufacturing Practice (GMP) requirements.

Provide additional information for updating registration records if necessary.

Notify about any changes that may affect the quality, safety, or efficacy of the medicinal product.

Compliance with these rules is mandatory to ensure the proper quality and safety of medicinal products used in Ukraine.

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