Registration (marketing authorization) of medicines

Medicinal products are allowed for sale and medical use in Ukraine only after state registration. The procedure for the state registration of medicines is aimed at preventing dangerous, ineffective medicines and medicines, the quality of which is unacceptable, from entering the market.

In drug registration processes, Ukraine adheres to the principles and standards adopted in countries with a strict regulatory system, such as member countries of the European Union, the United Kingdom of Great Britain and Northern Ireland, the United States of America (USA), Japan, the Swiss Confederation, Canada, Australia, Israel, and others. Ukrainian legislation on the registration of medicines and by-laws is harmonized with European regulations. The basis of the legislation of Ukraine on medicines is the Law of Ukraine “On Medicines.”

According to the law, medicines are:

• active pharmaceutical ingredients, in particular in the form of pellets, granules, and other forms of release;
• finished medicinal products;
• medicinal products in bulk packaging;
• medical immunobiological drugs;
• medical devices containing substances entering the systemic circulation during use;
• radiopharmaceuticals;
• blood and plasma preparations.

For radiopharmaceuticals and drugs based on blood and plasma, Ukrainian legislation establishes a particular procedure for state registration is applied.

State registration of medicines is carried out by the Ministry of Health based on the results of an examination of the materials of the registration dossier. The dossier examination is carried out by independent experts of the State Expert Center of the Ministry of Health of Ukraine, guided by the Procedure approved by the Order of the Ministry of Health of Ukraine No. 426 dated 26.08.2005.

To start the State registration of a medicinal product, the applicant must apply to the Ministry of Health of Ukraine. Based on the results of processing the application, the Ministry of Health of Ukraine sends a request to the State Expert Center. After that, the applicant submits to the State Expert Center of the Ministry of Health of Ukraine, for examination, the registration form of the medicinal product for one of the following types of product:

• medicinal product with the full dossier (innovative, original drug);
• the generic, hybrid drug, or biosimilar;
• medicinal product with a very established medical use;
• fixed combination drug;
• informed consent.

For each type of medicinal product, regulatory legal acts establish certain features in the examination procedure.

In order to conduct an examination of registration materials, the applicant submits to the State Expert Center of the Ministry of Health of Ukraine in paper and electronic form:

1. materials of the registration dossier in the format of the Common Technical Documents (CTD);
2. materials on methods of quality control of the medicinal product;
3. information about the manufacturing technology of the medicinal product and a copy of the official permit for manufacturing issued by the authorized body of the state where such manufacturing is carried out;
4. packaging labeling text;
5. notarized copy of the document confirming the compliance of the production conditions of the medicinal product submitted for registration (except for active pharmaceutical ingredients (substances) with the requirements of good manufacturing practice applicable in Ukraine);
6. document confirming the payment of the registration fee.

The first stage of examination of the drug dossier submitted for state registration is a preliminary examination. The purpose of the preliminary examination is to check the completeness of the materials of the registration dossier for a medicinal product, in accordance with the type of medicinal product, without assessing its content. In case of a positive result, the materials of the registration dossier are transferred for a specialized examination. The term for the preliminary examination is 14 working days.

A specialized examination of the materials of the registration dossier of a medicinal product is carried out by experts from the State Expert Center of the Ministry of Health of Ukraine with the possible involvement of external specialists. The purpose of specialized expertise is to verify data on the efficacy, safety, and quality of a medicinal product, as well as:

The Order of the Ministry of Health also approves:

• methods of drug quality control;
• the text of the labeling of the primary and secondary (if any) packages of the finished medicinal product;
• instructions for the medical use of the medicinal product;
• brief description of the medicinal product (if any).

Mentioned documents are the package of the Registration Certificate.

The result of our services for the state registration of a medicinal product is:

• Registration certificate of the medicinal product (medical immunobiological preparation);
• Entering it into the State Register of Medicines.

Archimed’s specialists will gladly provide additional information and advice on the state registration of medicines, as well as provide professional support for the state registration of medicines, representing your interests before all stakeholders: the Ministry of Health of Ukraine, the State Expert Center of the Ministry of Health of Ukraine, the State Service of Ukraine for medicines and drug control, as well as specialized laboratories.

In order to minimize the risks of a negative result at the first stage of the examination, the specialists of the Archimed company perform a preliminary audit of the registration dossier for a medicinal product until the application for state registration is submitted. As a result of the preliminary audit, the customer company receives a report on the completeness of the registration dossier and readiness to apply for state registration of the medicinal product.

We have significant and, most importantly, successful experience in registering medicines; therefore, we are ready to provide professional assistance to your company.

The Archimed team deeply understands the role of registration in the life cycle of a drug in the market. Unfortunately, not every agency understands that drug registration, although important, is only the first step toward a commercially and socially successful project. Therefore, we work for results, efficiently using time and optimizing the costs of our partners.