Radiopharmaceuticals – How to Register in EU? (October 2019)
Valentyna StarodubFounder and Chief Executive Officer
Radiopharmaceuticals are a specific type of medicinal products. When ready for use they contain one or more radionuclides (radio-isotopes). Radionuclides dissipate excess energy by spontaneously emitting radiation in the form of alpha, beta, positron and gamma rays. Radiopharmaceuticals make use of the radiation emitted by radioisotopes. They are used for therapeutic (destruction of diseased body cells) and diagnostic purposes (detection of radiation and transforming into images).
Is a radiopharmaceutical a human medicinal product and under what conditions does it require registration?