EXTENSION, RE-AUTHORIZATION AND AMENDMENT OF AUTHORIZATIONS

• Extension of the period of validity of the registration
The extension of the validity of the registration is to be requested within the 30-day period preceding the expiry of the registration.

The request for the extension of the validity of the registration is made by sending to the Commission the documents and information provided for in Art. 49, Art. 57 and Art. 58 paragraphs 1 and 3 of the Radiological Safety Norms – Authorization Procedures.

The copy of the acceptance tests is replaced by a copy of the most recent verification of the installation and of the most recent CNCAN inspection report, which must not be more than one year old.

• Re-authorization or extension of the period of validity of the authorization
Re-authorization is required if:
a) the extension of the period of validity of the authorization was not requested before its expiry;
b) it is intended to introduce new practices, radiation sources or radiological installations;
c) it is intended to modify the technical arrangements or the limits set out in the authorization;
d) the authorization has been withdrawn by the issuer, with the right to re-authorization.

The scrapping of installations or the handing over of radioactive sources as radioactive waste does not require an application for re-authorization.

Re-authorization is to be requested in accordance with the provisions of Art. 49 of the Radiological Safety Norms – Authorization Procedures. It is to be requested 45 days before the activities provided for in Art. 79 points b, c and d of the Radiological Safety Norms – Authorization Procedures are carried out.

The extension of the period of validity of the authorization is to be requested within a period of 45 days before the expiry date of the authorization. This deadline is considered to have been met if the re-authorization file has entered the evaluation process, as provided for in Art. 52 of the Radiological Safety Norms – Authorization Procedures, before the expiry of the authorization.

If the provisions of Art. 52 are complied with, the validity of the authorization for which the extension of the period of validity is requested is automatically extended for the duration of the evaluation process, but for no more than 2 calendar months. After this period, if a new authorization has not been issued, the authorization holder is required to cease its activity and to initiate the specific procedure for the cessation of activity, in accordance with Art. 100 of the Radiological Safety Norms – Authorization Procedures.

Where the authorization holder considers that the failure to issue the authorization within the time limit set out above is attributable to the Commission and is likely to cause it damage, it may request the application of the provisions of Art. 53 of Law no. 111/1996.

The extension of the period of validity of the authorization is requested by sending to the Commission a file, with numbered pages and containing a table of contents, consisting of:
a) application;
b) proof of payment of the fees and tariffs (Regulation on fees and tariffs);
c) the technical documentation.

The technical documentation for re-authorization or for the extension of the period of validity of the authorization shall contain at least the following information:
a) the manner in which the conditions imposed by the authorization or the provisions laid down in the inspection reports have been fulfilled;
b) an extract from the records of radiation sources and radiological installations reflecting the up-to-date situation; the list of dosimetry equipment;
c) the improvements regarding radiation protection and radiological safety;
d) the up-to-date list of the personnel involved in the authorized activities, stating their qualifications;
e) copies of the most recent verification tests of the radiation sources or radiological installations;
f) the reporting of any events that merit analysis from the point of view of radiological safety.

• Amendment of the authorization
The authorization may be amended:
a) by the Commission, on its own initiative, in accordance with the provisions of Art. 13 of Law no. 111/1996;
b) at the request of the authorization holder.

The authorization holder is required to request the amendment of the authorization in the following situations:
a) a change of name, a change of the registered office of the company or other changes to the company's articles of incorporation which alter the information on which the issuing of the authorization was based;
b) a change of the personnel with responsibilities in the field of radiological safety;
c) changes to the limits and conditions specified in the authorization;
d) other changes that could affect the safety of the radiation sources or the radiation protection of exposed personnel, of the public or of the environment.

The request for amendments is made by sending to the Commission an amendment file, with numbered pages and containing a table of contents, consisting of:
a) application;
b) proof of payment of the fees and tariffs (Regulation on fees and tariffs);
c) documentation supporting the need for the amendments requested.

The amendment of the authorization does not change its period of validity. If the Commission finds that the changes made or proposed do not meet the radiological safety requirements, it shall withdraw the authorization or prohibit the changes from being made.