Licensing and notification for veterinary practices

1. Log in to our e-service using your Freja eID or BankID.

2. Provide the following details:

Equipment:

• The make, model and serial number of the equipment (the serial number can be registered at a later date).
• If you purchased the equipment from a supplier, the supplier’s details.
• The address where your equipment will be used.
• The types of animals that will be examined or treated.
• A rough estimate of the number of monthly examinations by type of equipment.

General information on the organisation:

• Give the name of a contact person for the licence application.
• Describe the activity.
• Select your preferred means of invoicing and state your invoicing address and reference and the contact details of someone who can answer any questions concerning invoices.

Organisation and management:

• Upload an organisational plan showing your organisation’s structure and the roles and areas of responsibility of staff who work with ionising radiation. The plan should also describe the relationship between the organisation’s senior management, senior veterinarians, expert radiation safety functions and other relevant functions.
• If you do not have a formal organisation plan, you may describe your organisation in text form.
• Upload the veterinary licence or state the name and veterinary number of the veterinarian responsible for radiation safety in your organisation.

Radiation safety function:

• State whether your organisation has an expert radiation safety function approved by the Swedish Radiation Safety Authority or, if not, whether you wish to apply for dispensation from this requirement.
• If you intend to institute an expert radiation safety function, upload the degree certificate for each person in the function, as well as documentation certifying that the function has the relevant competence, experience and a reporting channel to the organisation’s highest management level.

Competence: 

• Upload documentation demonstrating how you ensure that staff have adequate competence to work with ionising radiation. This requirement does not apply if the veterinarian supervising work with ionising radiation is the only person in the organisation performing the procedure.

Staff protection:

• Upload documentation of the division of exposed staff into Category A or Category B and justify the categorisation, or state that staff are not divided into categories. Alternatively, upload a plan for measuring radiation doses as a basis for categorisation. This does not apply to organisations that only use stationary x-ray equipment with the beam field locked downwards.

Premises:

• Upload drawings of the premises where the equipment will be used. This requirement does not apply to ambulatory activities.
• Upload documentation describing the classification of the premises.

3. Review and sign your application.

When you sign your application you will receive a confirmation email. If you are applying for a new licence, you will also receive a payment request.

If you conduct nuclear medicine procedures or are unable to use the e-service, please contact us at Tillstandsprovning-stralskydd@ssm.se.

Once we receive your application, it will usually take between two and eight weeks to process. The processing time may be longer for larger or more complex operations. If the application is incomplete and supplementation is required, the processing time will be extended accordingly. If the requested information is not forthcoming, we may need to reach a decision based on the information we have to hand, or we may dismiss the application.

A decision concerning a licence under the Radiation Protection Act (2018:396) may be appealed to the Administrative Court in Stockholm. The decision includes instructions on how to lodge an appeal.

Pursuant to the Ordinance (2008:463) on certain fees to the Swedish Radiation Safety Authority, the following application fees apply to licensable veterinary procedures:

• SEK 3,500 for licensable x-ray diagnostics.
• SEK 2,300 for nuclear medicine with an activity up to 100 MBq.
• SEK 6,900 for nuclear medicine with an activity up to 10 GBq.

Licensable veterinary procedures are regulated in the following acts, ordinances and regulations:

Pursuant to Section 1 of Chapter 6 of the Swedish Radiation Protection Act (2018:396), it is prohibited to conduct unlicenced activities involving ionising radiation. Pursuant to point 1 in Section 2 of Chapter 9 of the same act, anyone intentionally or negligently breaching this prohibition may be sentenced to a fine or imprisonment for up to two years.

If you cease activities involving ionising radiation, you need to be able to demonstrate that all registered radioactive substances and x-ray equipment have been dealt with in accordance with Swedish Radiation Safety Authority regulations and report to us accordingly. We can then write-off your activity and annual fee. You are also required to decontaminate premises in which you have used radioactive substances as radioactive sources, so that the premises can be given clearance.

Deregistering radioactive substances

Contact the company from which you purchased the radioactive substance for assistance with safe handling and report the changes to us by completing and submitting the form for deregistering equipment.

Deregistering x-ray tubes

Deposit the x-ray equipment with a radioactive waste company and report the changes to us by completing and submitting the form for deregistering equipment. You also need to send us an original certificate in which you or the waste firm certifies that the x-ray tube is been rendered unusable.

Clearance of premises

Clearance is required for premises no longer used for work involving radioactive substances in the form of open radioactive sources. Obtaining clearance involves:

• the decontamination of all surfaces that may have been contaminated by the radioactive source;
• dealing with radioactively contaminated equipment and other inventory in a safe manner; and
• reporting the implementation of certain decontamination measures and the results of control measurements to the Swedish Radiation Safety Authority, which will then decide whether to grant clearance.

Clearance is regulated in Swedish Radiation Safety Authority Regulations (SSMFS 2018:3) concerning Exceptions from the Radiation Protection Act and the Clearance of Materials, Buildings and Areas.

1. Log in to our e-service using your Freja eID or BankID.
2. Select the type of activity you wish to register.
3. Provide the following details:
1. Invoicing address
2. Invoice reference
3. Preferred means of invoicing
4. Contact details for someone who can answer any questions
5. The make, model and serial number of the equipment (the serial number can be registered at a later date)
6. Any supplier information
7. Address where the practice is located
4. You also need to supply details of the equipment to which your application relates.

When you have signed your notification, a confirmation will be sent to your email address. This means that your notification has been approved. Save this confirmation as it is only generated once when you register.

Your notification is valid for five years. You can renew it no earlier than six months before it expires. The renewal must be submitted via our e-service.

You have automatic authorisation to log in to the e-service if you are an authorised signatory, CEO or director of the company. If the signatures of multiple directors are required, you will need power of attorney to log in. Power of attorney is also required if someone other than an authorised signatory or CEO is representing the organisation. Power of attorney is also required for sole traders, limited partnerships, economic associations, publicly owned companies and public authorities.

You can apply for power of attorney in two ways:

1. The authorised signatory or CEO can log in and delegate authority to represent the organisation. The representative must then log in and approve the information in the e-service.
2. The representative can log in directly to the e-service and enter and send their details.

In both cases, documentation of delegation must be attached and signed and approved by the authorised signatory or CEO. This must state the name and job title of the delegator and the name and personal identity number of the delegatee.

The Swedish Radiation Safety Authority will check the information and a case officer from the authority must approve power of attorney. A confirmation document will be emailed to the representative once power of attorney has been approved.

According to the Ordinance (2008:463) on certain fees to the Swedish Radiation Safety Authority, the fee for notifiable activities is SEK 1,850.

The obligation to notify is regulated by the following acts, ordinances and regulations:

If you no longer perform a procedure of which you have notified us, you can deregister your equipment or activity via our e-service.