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Under Article 4 of S.I. No.125 of 2000 a licence is required to carry out practices involving ionising radiation.
Any business or organisation which intends to become involved in storing, using, transporting, or disposing of radioactive materials, irradiation equipment or other sources of ionising radiation, must apply to the EPA for a licence before they acquire the radioactive substance or irradiating apparatus.
As a general rule, all practices which use radioactive substances or sources must hold a valid licence from the EPA. However, a licence is not required where the radioactive substance or irradiating apparatus is exempted under Article 5 of S.I. No.125 of 2000.
The RPA will carry out tests on the unit to verify that it is fit for purpose i.e. clinical use. Upon receipt of satisfactory commissioning reports, the licensing restriction will be removed and an amended Schedule 2 issued. The X-ray unit can now be used on patients.
Licences are divided into seven broad categories, covering the different types of practice. The broad categories cover the medical, dental, veterinary, industrial, distribution, research and educational sectors, with a further category for others (mainly state agencies).
If you intend to import / export a sealed radiation source from / to another European Union Member State, you must complete a shipment document, known as a 1493 form.
A licensee wishing to acquire or return a sealed source to a country outside the European Union must first obtain an import or export licence from the EPA’s Office of Radiological Protection. Read the guidance document on the import and export of sealed sources.
Yes, there is a one-off application fee, plus a licence fee.
If you are refused a licence you cannot obtain the radioactive substance or irradiating apparatus.
It normally takes up to one month to process a licence application though this can vary depending upon the complexity of the application.
You should apply for a licence as soon as possible but no later than one month before the date that you intend to acquire the irradiating apparatus or radioactive substance.
The licence application should be made in the name of a senior manager – e.g. the General Manager, the Managing Director, the Hospital Administrator, the Chief Executive or an equivalent.
You will be asked to provide detailed information about your business or practice, and the sources of radiation which you intend to acquire.
Prior to granting a licence you will have to demonstrate to the EPA’s Office of Radiological Protection that appropriate radiation protection arrangements are in place. These can be demonstrated by submitting appropriate Radiation Safety Procedures, a detailed risk assessment, a plan of your facilities and other relevant information. Our website has details on how to apply and pay for your licence.
In addition to meeting general legal obligations, licensees must also draw up their own Radiation Safety Procedures, specific to the practice. These are often referred to as ‘local rules’.
The Radiation Safety Procedures should deal with matters such as
Radiation Safety Procedures should always be revised whenever new radiation sources are acquired or other significant changes occur within the practice. Even where there have been no changes, the procedures should be reviewed annually; this review date should be included on the front cover of the document.
The EPA’s Office of Radiological Protection routinely carries out inspections to ensure that licensees are in compliance with safety procedures and both regulatory and licensing conditions.
The EPA has a number of options for dealing with failure to comply with licensing conditions. These include
The decision will depend upon the seriousness of the breach of conditions.
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