Technical documentation for the authorization of practices and of use – operation

• THE FILE for authorization of the USE activity

1. Application;
2. Copies of the documents proving that the applicant is a legally established entity;
3. Technical documentation for authorization;
4. Copies of the authorizations or endorsements issued by other state bodies, required by law;
5. Other information considered necessary by the applicant in support of the application;
6. Proof of payment of the fee and tariff (Regulation on fees and tariffs).

· The technical documentation for authorization required to obtain the radiological safety authorization for practices or for the use of radiological installations and/or radiation sources must contain all the information needed to demonstrate compliance with the provisions of the applicable specific regulations and to allow assessment of the degree to which radiological safety is achieved. The information shall cover, as the case may be, at least the following:

· The justification, optimization and description of the practice;
· A description of the radiation sources and radiological installations;
· The management of radioactive waste and the release of radioactive effluents;
· A description of the premises and buildings used;
· The dose limitation programme and the applicable constraints, the ALARA principle;
· The classification of workplaces into controlled areas and supervised areas, the site plans;
· The classification of occupationally exposed workers into categories;
· Dose assessment, the monitoring system, the accredited dosimetry body;
· The training and authorization of personnel;
· The individual and collective radiation protection equipment;
· The radiological safety officers by area and the radiation protection experts;
· The impact on the public and the environment;
· Preservation and decommissioning;
· Potential exposures and the countermeasures;
· The internal documents governing the practice, including those of the quality system.

· The documentation shall contain the statement of expert review and acceptance of the documentation, signed by the radiation protection expert mentioned in the application.
· The statements in the technical documentation shall be supported by copies of the supporting deeds and documents.
· The sketches or plans must be drawn up in accordance with the technical prescriptions in the field, must be legible and must be signed by the person who drew them up. The siting – assembly – installation plans must be correlated with the accompanying descriptive text and sufficiently detailed to allow verification that the prescriptions of the specific regulations are met.
· For practices that are authorized in phases, the technical documentation must contain the relevant information for each phase. The documentation for the subsequent phase shall also demonstrate that the objectives of the previous phase have been achieved.
· The technical documentation for siting must clarify the impact on the environment and on other human activities in the area, both for normal operation and in the case of potential exposures.
· The technical documentation for construction must present the solutions adopted to achieve the level of radiological safety proposed in the previous phase, including substantiation by calculations and specific design materials.