ATCO.MED.B.090 Oncology

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Regulation (EU) 2015/340

(a) After diagnosis of primary or secondary malignant disease, applicants shall be referred to the licensing authority and shall undergo satisfactory oncological evaluation before a fit assessment may be considered.

(b) Applicants with an established history or clinical diagnosis of an intracerebral malignant tumor shall be assessed as unfit.

AMC1 ATCO.MED.B.090 Oncology

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      ED Decision 2015/010/R

(a) Applicants who have been diagnosed with a malignant disease may be assessed as fit provided:

(1) after primary treatment there is no evidence of residual malignant disease likely to interfere with the safe exercise of the privileges of the license;

(2) time appropriate to the type of tumor has elapsed since the end of primary treatment;

(3) the risk of incapacitation from a recurrence or metastasis is sufficiently low;

(4) there is no evidence of short- or long-term sequelae from treatment. Special attention should be paid to applicants who have received anthracycline chemotherapy;

(5) satisfactory oncology follow-up reports are provided to the licensing authority.

(b) Applicants receiving ongoing chemotherapy or radiation treatment should be assessed as unfit.

(c) Applicants with a benign intracerebral tumor may be assessed as fit after satisfactory specialist and neurological evaluation and the condition does not compromise the safe exercise of the privileges of the license.

(d) Applicants with pre-malignant conditions may be assessed as fit if treated or excised as necessary and there is a regular follow-up