Technical documentation for the radiological safety authorization for the product

• THE FILE for authorization of the product RADIOLOGICAL SAFETY AUTHORIZATION

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 the product must contain, as the case may be, sufficient information about:

· design and manufacture;
· the testing programme and its results;
· the quality assurance system;
· the purpose for which it was designed;
· installation, assembly, maintenance;
· operation / use;
· labelling, marking;
· servicing, repair;
· the accompanying documentation;
· the method of decommissioning or of disposal as waste;
· other hazards it may generate.
· The technical document characterizing the product may also be drawn up in English or in French.
· The applicant must submit, at the request of the Commission, copies of the international or national documents or regulations with which it claims to comply, in Romanian, English or French.
· The operating manual or the instructions for use must be drawn up in Romanian and submitted in the form in which they are supplied to users.