State registration and re-registration of medicinal products in Ukraine

State registration of medicinal products is an official procedure through which a medicinal product receives authorization for circulation and use in Ukraine. Its purpose is to ensure that the product is of high quality, effective, and safe for patients. Without completing this procedure, it is prohibited to manufacture, import, or sell any medicinal product in Ukraine.

The main regulatory act is Resolution of the Cabinet of Ministers of Ukraine No. 376 of May 26, 2005, which approves the Order of State Registration (Re-registration) of Medicinal Products. The procedure is also regulated by the Law of Ukraine “On Medicinal Products” No. 2469-IX (2022). The competent authority is the Ministry of Health of Ukraine (MoH), and the expert evaluation of materials is carried out by the State Expert Center of the MoH of Ukraine (SEC).

Stages of state registration of medicinal products

The registration process consists of several mandatory stages:

• Preparation of the application and registration dossier

The applicant may be a manufacturer, importer, or an authorized representative. The following must be submitted to the Ministry of Health:

1. an application for state registration of a medicinal product;
2. a registration dossier containing information on composition, manufacturing methods, results of preclinical and clinical studies, and quality control methods;
3. packaging samples, draft instructions, and labeling;
4. GMP documents (Good Manufacturing Practice);
5. proof of payment of the state registration fee.

The dossier is formed according to the modular CTD (Common Technical Document) format and must comply with EU requirements. Errors or incomplete information often lead to delays or refusal of registration.

• Expert evaluation of the medicinal product

The State Expert Center conducts:

1. a preliminary evaluation (verification of completeness of documents);
2. a specialized evaluation assessing the quality, efficacy, and safety of the product;
3. a pharmacological assessment (if necessary).

During the evaluation, the applicant may receive requests for clarifications or additional materials. The duration of the evaluation usually does not exceed 210 calendar days.

• Decision-making and entry into the state register

After receiving a positive conclusion from the State Expert Center, the Ministry of Health issues a decision on the state registration of the medicinal product. A registration certificate is issued, confirming the right to manufacture, import, and sell the product. The medicinal product is then included in the State Register of Medicinal Products of Ukraine.

The validity period of the registration certificate is 5 years, after which re-registration is required.

Re-registration of medicinal products: when is it required?

Re-registration is conducted to extend the validity of the authorization or after significant changes are made to the dossier. In particular, the procedure is required if:

• the place or manufacturing technology has changed;
• the composition or dosage form has been updated;
• legislative or technical requirements have changed;
• new data regarding safety or efficacy have appeared;
• the five-year validity period of the registration certificate is expiring.

For re-registration, an updated dossier and proof of payment of the required fee must be submitted. The Ministry of Health may request additional studies or documentation. If the applicant fails to apply on time, the registration certificate becomes invalid, and the sale of the medicinal product becomes illegal.

Special features of registration during martial law

During martial law, simplified procedures are in effect. The Ministry of Health may grant temporary state registration of medicinal products if they are already registered in the EU, USA, Switzerland, Japan, the United Kingdom, or Canada. This allows rapid access to essential medicines without compromising quality standards.

Legal risks and common applicant mistakes

1. Non-compliance of documents with legal requirements. Dossiers often contain translation inaccuracies or incorrect data about the product composition.
2. Violation of patent rights. If the product falls under intellectual property protection, the applicant must prove that no patent is infringed.
3. Failure to re-register on time. Missing deadlines automatically leads to cancellation of the registration certificate.
4. Lack of proper legal support. Incorrect documentation or missed deadlines can disrupt the product’s entry into the market.

Legal support for medicinal product registration

Professional legal support for the state registration of medicinal products includes:

• analysis of the legal grounds for filing the application;
• preparation of the registration dossier according to MoH requirements;
• communication with the SEC and MoH during the evaluation process;
• verification of patent clearance of the medicinal product;
• support during re-registration or amendments to the dossier.

Lawyers of “Prikhodko & Partners” assist manufacturers, importers, and distributors in completing all stages of the procedure without risk of refusal. We consider not only legal requirements but also the practical approach of the Ministry of Health, which helps reduce processing time and avoid bureaucratic delays.

State registration of medicinal products in Ukraine is a complex but mandatory procedure for every manufacturer or importer. It ensures lawful circulation of products, consumer protection, and strengthens the company’s reputation. Re-registration of medicinal products allows maintaining updated product data and prolonging its presence on the market.

To avoid errors, delays, and refusals, it is important to involve lawyers who specialize in pharmaceutical law. The team of “Prikhodko & Partners” provides complete support — from dossier preparation to obtaining the registration certificate from the Ministry of Health of Ukraine.