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Advising on Radiopharmaceutical Clinical Studied in Russia

Task

Preparing a comprehensive legal opinion on the qualification peculiarities and the procedure of importation of a drug containing Ra-223 into Russia as part of clinical studies

Client
Swedish drug manufacturer
Industry
Development of anticancer drugs

Background

To provide a targeted therapy in treating cancer diseases, our client intended to import a Ra-223-based drug pertaining to controlled products that require a licence to be imported.

As the agent has no licence from the Federal Service for Technical and Export Control (FSTEC), the client asked us to advise them on the possibility to import and the operating peculiarities of radionuclides.

Outcome

The collaboration between lawyers and pharmacists confirmed the true energy specifications of alpha particles, resulting in a conclusion that no licence was actually required.

The successful testing will make it possible to launch a new drug for targeted therapy on the market and make today’s most advanced treatment available to a larger number of patients.