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Continuing to meet the needs of patients across Europe should, in the opinion of the European Association of Hospital Pharmacists (EAHP) and the European Association of Nuclear Medicine (EANM), be one of the guiding principles for the revision of the general pharmaceutical legislation. Consequently, both associations have joined forces and recently issued a joint statement on the availability of radio-pharmaceuticals in the context of the revision of the general pharmaceutical legislation.

The Joint Statement touches on the need for a flexible regulatory framework for low-volume products and enhancing the security of the supply of medicines and addressing shortages. The following calls to action are included:

  • Due to the difference between commercial and non-commercial preparations of radio-pharmaceuticals, EAHP and EANM are calling for a specific approach to the regulation of small-scale preparation of radio-pharmaceuticals.
  • To further improve patient care, EAHP and EANM encourage (health) authorities to invest in in-house production services, including compounding services and the preparation of radio-pharmaceuticals, and the provision of training tailored to specific preparations, including the expansion of training opportunities. With respect to radio-pharmaceuticals, in-depth knowledge of radiochemistry, radiation safety automated procedures and radiation measurement technology are of particular importance.
  • The review of the Pharmaceutical Legislation should consider that, within hospital pharmacies and radio pharmacies, the demand for marketing authorisation should be strictly limited to starting materials and radionuclide precursors used in kit procedures and not for starting materials and radionuclide precursors if used in complex radiopharmaceutical preparations.
  • EAHP and EANM have called for improved information exchange between authorities and supply chain actors and the relay of information to the end-users. For combatting medicine and radionuclide shortages, best practice sharing is essential, and implementation support for shortage management strategies needs to be provided in the interests of patient safety.