[en] A national programme on radiation protection of patients can only be effective and sustainable if there is a joint effort between the regulatory body and the health authorities, and a cooperation with educational institutions, professional bodies and representatives of the industry. The regulatory body needs to promote a strategy of cooperation, and to identify obstacles that may prevent compliance with regulatory requirements and to address them. Not of least is the need for a continuous self-evaluation on the efficacy of the programme. Radiation safety of the patients is a responsibility of the users of the radiation sources involved in diagnostic and treatment. In particular, they are responsible for compliance with regulatory requirements. But safety depends also on aspects that are beyond the capabilities of those authorized to conduct practices. These aspects include educational programmes and institutions to implement them, calibration facilities, national protocols, professional bodies for the establishment of reference levels and contributions from the industry. Neither the users nor the regulatory body alone can achieve that these elements are in place. It needs a network of institutions and cooperation arrangements that involve educational and health authorities, laboratory facilities, professional bodies and the industry. A national programme has to include a strategy of cooperation, identification of obstacles that may prevent compliance with regulatory requirements and address them. Not of least is the need for a continuous self-evaluation on the efficacy of the programme. A group of regulatory agencies belonging to the Ibero American Forum of Nuclear and Radiation Regulatory Agency have exchanged experiences, lessons learned and good practices over three years. This exchange included extensive collaboration with the health authorities. The result of this work is this document containing a self-evaluation approach for the regulatory programme on radiation protection and safety in medical exposure