Definition of a new active substance

  • A chemical, biological or radiopharmaceutical substance not previously authorised as a medicinal product in the European Union;
  • An isomer, mixture of isomers, a complex or derivative or salt of a chemical substance previously authorised as a medicinal product in the European Union but differing in properties with regard to safety and efficacy from that chemical substance previously authorised;
  • A biological substance previously authorised as a medicinal product in the European Union, bur differing in molecular structure, nature of the source material or manufacturing process;
  • A radiopharmaceutical substance which is a radionuclide, or a ligand not previously authorised as a medicinal product in the European Union, or the coupling mechanism to link the molecule and the radionuclide has not been authorised previously in the EuropeanUnion

喜歡這篇文章嗎?立即分享

你可能感興趣的文章