• To obtain authorisation for the procedures referred to in points 1–6 and 9 of Part C of Annex I, the organisation shall submit the following:

(a) a list of the practices applied and the design characteristics of the facility including the following:

aa) a detailed list of the radiation sources held by the facility, including, where applicable, the certificates for the radioactive sources. In particular, where high-activity sealed sources are used, the specific requirements of Article 88 of Presidential Decree 101/2018,
(bb) where radioactive sources are used, a solemn declaration by the organisation’s legal representative stating that the organisation (a) undertakes all appropriate administrative and financial measures for the safe management of radioactive sources at the end of their useful life, ensuring the return of the radioactive sources to theforeign supplier or their dispatch to an authorised radioactive material management facility abroad (b) has taken all the radiation protection measures and precautions required by the legislation in force,

(b) a valid feasibility licence,

(c) a list of names and training in radiation protection, and the classification of exposed workers into categories A and B, as well as the details of those in charge of the organisational units (of the organisation) where the practices are implemented. Specifically in the case of medical reports, the following are submitted, by group of practices (grouped, where appropriate, by organisational unit of the organisation), the details of the medical physics experts(as required under Article 58 of Presidential Decree 101/2018),

(d) a radiation protection and safety report by a radiation protection expert, containing the following:

aa) specification of operational limits, dose constraints and operating conditions,
bb) a shielding study,
cc) study of radiological environmental impacts, where applicable,
(dd) expected occupational and public exposures,
(ee) a programme for individual dosimetry and workplace monitoring,
(ff) a programme for the maintenance, testing and regular inspection of equipment and operating conditions in general,
gg) management of radioactive waste, including patients’ excreta, and measures for the final disposal of such waste, where radioactive sources are used,
(hh) management of disused sources and measures to prevent any loss, significant leakage, theft or unauthorised use of radioactive sources and materials,
i) accident analysis and emergency procedures,
(ii) identification of ways in which potential exposures or accidental exposures may arise and, in the case of medical practices, involuntary medical exposures, and assessing, as far as practicable, the likelihood and magnitude of potential exposures,
(ia) a quality assurance programme,
(ib) radiation protection measures and a description of administrative procedures (in particular procedures relating to pregnant or breastfeeding workers),
(iig) record-keeping procedures, specifically for practices involving the use of open and sealed sources.

It should be noted that:

a. For radiotherapy practices relating to points 1 and 2 and the practices referred to in point 9 of Part C of Annex I, a floor plan and cross-sections must be submitted, showing all areas of the facility, the supervised and controlled areas, the special protective measures, the location of radiation sources, and the use of the premises and areas adjacent to the facility

b. For the purposes of point 9 of Part C of Annex I, in addition to the information referred to in point (a) above, the organisation shall also submit the following:

aa) a description of the accelerator or the high-activity sealed source assembly and the associated systems and equipment,
(bb) a description of the primary and secondary radiation, as well as the potential activation of materials,
(cc) a risk assessment study of non-radiological hazards (for example: production of toxic gases, electrical and mechanical hazards) and a description of the corresponding protective measures and arrangements,
(dd) a list of the applicable safety standards and industrial standardisation standards, in addition to the Greek ones, proposed by the organisation.

c. For practices involving high-activity sealed sources (points 2, 6 and 9 of Part C of Annex I), the organisation shall submit documentation demonstrating financial security in accordance with point (b) of Article 87 of Presidential Decree 101/2018, and the framework set out in Annex XIV to Presidential Decree 101/2018 shall apply.

d. For the procedures set out in points 3 and 4 of Part C of Annex I, the organisation shall submit the marketing authorisation issued by the National Organisation for Medicines or by a corresponding European or international organisationrecognised by the Greek State, or other documentation from a competent state authority, confirming the authorisation for the use of the medicinal products it utilises within the framework of the said practices.

The licence for these practices is valid for five (5) years, unless specific reasons warrant a shorter duration.
The organisation shall submit an application to the EEAE for the renewal of the authorisation, at least three (3) months before its expiry, resubmitting the updated information and the required supporting documents.

• For the authorisation of practices referred to in point 7 of Part C of Annex I to this Regulation, the organisation shall submit the following, where applicable:

(a) a description of the product and its intended use, including the rationale, the function and/or use of the product, any shielding, the radionuclides, their physical and chemical form and specific concentration (number of products produced or manufactured per year, activity per product or concentration of radioactivity),

(b) a nominal list, job descriptions and information and training on radiation protection for staff of the organisation involved in the production or manufacture of the product,

(c) management procedures during the production or manufacture of the product, any shielding or other spatial arrangements,

(d) a procedure for informing the public about the recommended options for recycling or disposal of the product at the end of its useful life, the external dose rate at any accessible surface of the product, and the possibility of its repair or maintenance,

(e) a description of the management chain.

The licence is valid for a specific period, which is determined by the EEAE for each type of practice and is stated on the licence. The duration shall not exceed five (5) years.

• The organisation carrying out practices referred to in point 8 of Part C of Annex I shall submit the following, where applicable, depending on the type of product:

(a) a description of the product and its intended use, including the radionuclides, their physical and chemical form and their specific concentration,

(b) the methodology for incorporating the specific radionuclides,

(c) details of the shielding and the radionuclide container, and their resistance under normal operating conditions and in emergency situations such as fire, destruction, crushing, dropping, extreme environmental conditions, etc.,

(d) the maximum external dose rate at any accessible surface of the product,

(e) procedures for handling the product (and in particular during incorporation with radionuclides), any shielding or other spatial arrangements, and the training of exposed workers,

(f) a schematic diagram of the product showing the position of the radioactive source,

(g) a marketing authorisation from the National Organisation for Medicines or from a corresponding European or international organisation recognised by the Greek State, or other documentation, from a competent state authority, authorising the use of the medicinal products,

(h) methods for disposing of the product or its derivatives once its useful life and operation have ended,

i) storage areas, radiation protection and safety measures, where the products are stored on the organisation’s premises;

(j) a solemn declaration that appropriate provision has been made, in the form of financial security or any other equivalent means appropriate for the materials in question, with the exception of open sources, for the purpose of their safe management when they are taken out of service, including in the event that the beneficiary becomes insolvent or ceases its activities.

In the event of the import of radioactive sources, excluding unsealed sources, a written confirmation from the manufacturer/supplier based abroad confirming that they accept the return of the sealed sources at the end of their useful life, as well as the submission of the standardised document (ANNEX I) of Council Regulation (Euratom) No 1493/93 for the dispatch of a sealed source from an EU Member State.

The licence is valid for a specific period, which is determined by the EEAE for each type of practice and is stated on the licence. The duration shall not exceed five (5) years.

• For the licensing of the activities referred to in point 10 of Part C of Annex I (dismantling of installations falling under point 9 of Part C of the same Annex), the organisation shall submit an application to the EEAE containing the following:

(a) a detailed programme of the decommissioning works, which shall include, by way of example:

aa) a justification and description (including technical details and a timetable) of the decommissioning method,
bb) a study setting out the expected occupational exposure and measures to limit it,
cc) a description of the radioactive waste expected to be generated during the decommissioning process (type, classification, volume, activity and toxicity) and its management through to the final stage,
(dd) an assessment of the final state of the site from a radiation protection perspective and a description of its future use, where this can be estimated

(b) arrangements and commitments, including the necessary financial resources, for the management and possible transfer of radioactive sources and materials and/or radioactive waste expected to be generated during decommissioning.

The EEAE shall set up a special advisory committee to carry out the assessment. In the event of a positive assessment, taking into account the committee’s opinion, the EEAE grants the organisation a licence, on the basis of which work on the decommissioning of the facility may commence.

Upon completion of the decommissioning works, the organisation shall submit to the EEAE a report by a radiation protection expert detailing the management of radioactive materials and/orwaste resulting from the decommissioning, as well as the status of the site from a radiation protection perspective.

The EEAE assesses the report referred to in paragraph 3 and, where appropriate, carries out an inspection of the site. Members of the special advisory evaluation committee may also take part in the inspection.

The EEAE, taking into account the above report and the results of the inspection, submits a relevant recommendation regarding the completion of the decommissioning and restoration of the site from a radiation protection perspective to the competent Minister, who then, by decision, proceeds to release the area from regulatory control.

• In order to obtain a licence for the practices referred to in point 11 of Part C of Annex I, the organisation shall submit the following:

(a) a description of the radioactive materials to be transported,

(b) a description of the transport containers and documented evidence of compliance of the transport container design with the EEAE guidelines,

c) a list of staff involved in these practices, information and training on the transport of radioactive materials, job descriptions,

(d) a programme of continuing professional development,

(e) a nationwide plan for the transport of radioactive materials,

f) a certificate confirming compliance with all terms and conditions relating to the operation of transport vehicles,

(g) a quality assurance and radiation protection programme for the practices in place, including operating instructions for normal transport conditions,

(h) an emergency response plan, including the immediate notification of national and local authorities,

i) security measures against unlawful acts, incorporating actions relating to detection, delay and response.

The licence is valid for three (3) years or, in duly justified cases, for a shorter period. To renew it, the organisation must submit an application to the EEAE at least three (3) months before its expiry.

• For the authorisation of a single consignment of a high-activity sealed source, radioactive or fissile materials with significant consequences within the meaning of point 12 of Part C of Annex I, the organisation shall submit the following:

(a) points (a), (b), (c), (f), (g), (h) and (i) of the section ‘Authorisation for the systematic transport of radioactive materials’,

(b) details of the consignor and the consignee,

(c) an estimated departure and arrival schedule and at least two (2) proposed routes.

The licence is valid for a specific period, which is determined on a consignment-by-consignment basis. To renew it, the organisation must submit an application to the EEAE at least seven (7) calendar days before its expiry date.

Where the radioactive sources or materials to be transported fall within the enhanced safety level category, the organisation must also notify the EEAE and the consignee of the consignment details at least seven (7) calendar days before the start of the shipment.

The EEAE, following an assessment of the information and supporting documents submitted, and in the event of a positive assessment, shall grant the organisation the licence, in accordance with the provisions of paragraphs 3 and 4 of Article 29 of Presidential Decree 101/2018.

The assessment is carried out to verify compliance with the Radiation Protection Regulations and to evaluate the measures taken to implement the principle of optimisation. During the assessment,account, amongst other things, the dose limits for occupational exposure and public exposure, as well as the assessment of doses via all exposure pathways for members of the public that may result from radioactive dischargesduring the implementation of the procedures.
The EEAE, if it deems it appropriate, shall carry out an inspection of the organisation prior to the issue of the licence.