Application for License, Amendments, or Renewal

(A) An application must be signed by the applicant's or licensee's management. (B) An application for a license for medical use of radioactive material as described in 105 CMR 120.544, 120.547, 120.552, 120.559, 120.568, 120.570 or 120.589 must be made by: (1) Filing an original and one copy of Agency application form MRCP 120.100- 4 that includes the facility diagram, equipment, and training, experience and qualifications of the Radiation safety Officer, Associate Radiation Safety Officer(s), authorized user(s), authorized medical physicist(s), ophthalmic physicist(s), and authorized nuclear pharmacist(s); and (2) Submitting procedures required by 105 CMR 120.573, 120.579, 120.580 and 120.581, as applicable. (C) A request for a license amendment or renewal must be made by: (1) Submitting an original of either: (a) Agency form MRCP 120.100- 4; or (b) a letter containing all information required by Agency form MRCP 120.100- 4; and (2) Submitting procedures required by 105 CMR 120.573, 120.579, 120.580 and 120.581, as applicable. (D) In addition to the requirements in 105 CMR 120.507(B) and (C), an application for a license or amendment for medical use of radioactive material as described in 105 CMR 120.589 must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in, or differ from, 105 CMR 120.501 through 120.543 and 105 CMR 120.590 through 120.594, identification of and commitment to follow the applicable radiation safety program requirements in 105 CMR 120.547 through 120.587 that are appropriate for the specific 105 CMR 120.589 medical use, as well as any specific information on: (1) Radiation safety precautions and instructions; (2) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and (3) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety. (E) The applicant or licensee shall also provide any other information requested by the Agency in its review of the application. (F) An applicant that satisfies the requirements specified in 105 CMR 120.127(B) may apply for a Type A specific license of broad scope.