IRRS follow-up mission to France - October 2017

28 A significant number of activities which are currently licensed will fall under the registration or notification scheme. The activities which require notification will not have a time limitation on their validity. The registration scheme will be a simplif ied licensing process which requires a simpler application with less supporting documentation. These proposals are supported by the Regional Divisions of ASN who undertake the majority of authorizations within ASN. The IRRS team was provided the proposed graded approach to authorization, including the duration of the authorization. It was noted that the proposed licence duration for the majority of medical practices, including external radiotherapy and brachytherapy, should be 10 years. This proposal does not appear to take account of the risk of practices changing during this relatively long time period. In addition, the proposed duration for registration and licensing of some medical practices should be both 10 years which does not appear to be consistent with the graded approach. Practically, in case of significant change of the practice, the license or the registration will be updated. Suggestion 7: The updated PHC will come into effect in early 2018 which will introduce an additional category of authorization as detailed in Recommendation 7 above. Following this update to the PHC, ASN will progressively reissue authorizations to a legal entity rather than a person as they become due for renewal e.g., on licence expiry, licence amendment etc. It is estimated that this will affect approximately 10 000 authorizations which will be reissued over a period of 3-5 years. Recommendation 8: The updated PHC will come into effect in early 2018, which defines the framework for registering and tracking radioactive sources. The ASN resolution 2015-DC-0521 which entered into force in January 2016 is foreseen in the updated PHC and details the process and actions that have to be taken to register a source in the national register. As has been described in Recommendation 7, the draft decree has been approved in principle by the Government but still requires review by the Council of State before it can be issued in early 2018.