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If you wish to operate a mobile X-ray unit for use on animals in veterinary medicine, you must submit an application for approval. You must also do this if this activity requiring a permit changes.

Are you a veterinarian or do you employ a veterinarian and would like to operate a mobile X-ray unit in connection with the use on animals in veterinary medicine or are there significant changes in the operation of this X-ray unit? This requires approval from the competent authority.

After you have submitted this application, the competent authority will check that your documents are complete and that you meet the legal requirements for the issue of a permit.

The permit holder can be a partnership with legal capacity, a legal entity or a natural person. The permit always refers to the person responsible for radiation protection. If there are any changes in the radiation protection organization, please contact the competent authority to discuss or arrange the next steps.

An example of a significant change is the replacement of the image receiver of the already approved X-ray equipment.

The list of required documents for the application for permits can be found in Annex 2 Part C of the Act on Protection against the Harmful Effects of Ionizing Radiation (StrlSchG)
In particular:

• Proof of expertise in radiation protection including proof of updating
• Certificate and the expert test report
• Result of the quality assurance
• Type approval certificate
• Proof of knowledge of radiation protection for the personnel deployed, including updates to these certificates

In the case of approval of systems for use on animals, a license to practice medicine or proof of temporary exercise of the medical profession must also be submitted.

Approval is granted if the statutory approval requirements are met.

These are fulfilled if :

1. there are no facts giving rise to concerns about the reliability of the applicant, his legal representative or, in the case of legal persons or associations of persons without legal capacity, the persons authorized to represent or manage the company in accordance with the law, articles of association or partnership agreement and, if a radiation protection officer is not required, one of the aforementioned natural persons has the necessary expertise in radiation protection,
2. there are no facts that give rise to concerns about the reliability of the radiation protection officers and they have the necessary expertise in radiation protection,
3. the number of radiation protection officers necessary for the safe performance of the activity has been appointed and they have been granted the necessary powers to perform their duties,
4. it is ensured that the persons otherwise involved in the activity have the necessary knowledge and skills with regard to the possible radiation hazard and the protective measures to be applied,
5. there are no facts giving rise to doubts as to whether the personnel required to carry out the activity safely are available,
6. it is ensured that the equipment is available and that the measures are taken which are necessary for an activity in accordance with the state of the art so that the protective regulations are complied with,
7. it is not an unjustified type of activity according to a legal regulation or if, taking into account a published report, there are no significant doubts about the justification of the type of activity, and
8. other regulations under public law do not conflict with this.
9. Furthermore, a license to practice medicine or a temporary authorization to practice medicine exists.
   

You send the application for approval for the operation or significant modification of an X-ray device to the competent authority.

Upon receipt of the application and the complete documentation, the competent authority will check whether the requirements for approval have been met.

After a final assessment by the competent authority, you will receive the decision in the form of a notification. The notification of costs will be issued separately.

The application for approval must be submitted before commissioning or before making any significant changes.

The X-ray equipment may only be put into operation once approval has been granted.

Approval must be obtained before the X-ray equipment is put into operation. The same applies to the planning of significant changes.

If the permit is not granted, an action can be brought before the competent administrative court after receipt of the decision.

• Operation of an X-ray unit or significant change to the operation Permit
• The operation of mobile X-ray equipment for use on animals in veterinary medicine requires a permit.
• Significant changes to an already approved facility must also be approved
• This does not apply to X-ray equipment for the operation of which a notification is sufficient, even taking into account the need for approval
• Responsible: Regional councils

Please contact the regional councils.

Forms available: Yes
Written form required: Yes
Informal application possible: No
Personal appearance necessary: No