According to the Law of Ukraine “On Medicinal Products” and regulatory acts, there are several options for importing APIs without an import license:

1. Import for state registration

If an API is imported for the registration of a new medicinal product, it can be imported without an import license, but a permit from the State Service of Ukraine for Medicinal Products and Drug Control (SSMDC) will be required.

2. Import for research and development

If an API is imported for scientific research or laboratory testing, it can be registered as a sample for scientific purposes.

What is required:

• Agreement with a scientific or research organization;

• Justification of the need for import;

• Certificates of quality and origin of the API;

• Permit from the State Service of Ukraine for Medicinal Products and Drug Control or the Ministry of Health.

What is required:

• Application to the State Service of Ukraine for Medicinal Products and Drug Control indicating the purposes of import (for registration);

• Documents confirming the conduct of clinical or preclinical trials;

• Contract with the laboratory that will conduct the research;

• Documents on the quality of the API (certificate of analysis, COA);

• Import permit from the State Medical Service.

3. Import within the framework of clinical trials

If the API is needed for clinical trials of a medicinal product, it can be imported within the framework of an agreed clinical trial plan with the permission of the Ministry of Health of Ukraine.

What to do next?

1. Prepare a package of documents in accordance with the import.

2. Submit an application to the State Medical Service or the Ministry of Health.

3. Obtain an import permit.

4. Declare the API at customs (certification of conformity may be required).