THE AUTHORIZATION FILE

• The authorization file
The authorization or registration file shall have numbered pages and shall include a table of contents.

All documents in the authorization file must be legible and printed - typewritten or produced on a printer. Documents sent by fax are not accepted.

Where copies of supporting documents are required, they shall be photocopies or typewritten copies, authenticated or confirmed under signature by the applicant. Copies made or sent by fax are not accepted.

The authorization documents shall be submitted in a binder file.

The information contained in the authorization or registration files is confidential. The employees of the Commission are required to respect its confidentiality or the secret nature of certain information, if it has been declared as such by the applicant, subject to the penalties provided by the laws in force.

Files that are incomplete, within the meaning of Art. 49 of the Radiological Safety Norms – Authorization Procedures, do not enter the evaluation process.

The Commission shall notify, by letter, within a maximum of 30 days, the additions that are required. If these additions are not received within one month at most from the date of the notification, the file is rejected without any further warning and the applicant may no longer make subsequent reference to it, claim the use of parts of it, or claim back the fees and tariffs paid.

Files that are complete, within the meaning of Art. 49 of the Radiological Safety Norms – Authorization Procedures, enter the evaluation process, during which the Commission may request clarifications, evidence in support of the statements made, expert assessments, the reworking of parts of the file and the direct participation of the qualified person representing the applicant, and may carry out inspections and set deadlines for providing the additions requested. Failure to meet these deadlines without the prior agreement of the Commission leads to the rejection of the authorization application.

For practices and activities that are authorized in phases, an inspection is mandatory at the commissioning phase.

Rejected files, or parts of them, may not be used subsequently for other authorization applications on the grounds that they have already been submitted to the Commission.

The use of the technical documentation in the authorization file by another importer in order to obtain a product radiological safety authorization is permitted only with the written consent of the legally established entity that holds the file.

The evaluation process lasts no more than two months and is concluded by the issuing of the authorization or by a letter notifying the reasoned and duly justified refusal of the authorization, where the authorization conditions are not met.

Incomplete or rejected files are not returned.

The second copy of the authorization or registration file is returned to the applicant together with the authorization or registration certificate issued. These files shall bear a registration number and each page of the file shall bear the stamp of the Commission.

The applicant for an authorization may lodge an appeal, with duly documented arguments, by means of a statement addressed to the President of CNCAN, within two months of the date of receipt of the letter notifying the refusal of the authorization.

Applying for registration or authorization