Licence condition M1748 requires management licence holders to comply with the requirements specified in the Supplementary quality control requirements for radionuclide generators document.
This document describes the obligations of management licence holders where condition M1748 has been imposed on an authorisation on the management licence. The requirements apply to quality control of radioactive material produced from radionuclide generators.
The requirements are divided into general requirements and specific requirements. The general requirements apply to all radionuclide generators whereas the specific requirements apply to specific types of generators. All management licence holders required to comply with condition M1748 must satisfy the Mandatory requirements. All management licence holders authorised to possess a molybdenum-99/technetium-99m generator must also satisfy Specific requirements part 2.1.
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