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Fluorine-18 radioisotopes and MHRA licences

Date released
15 February 2021
Request number
202101063
Release of information under
Freedom of Information Act 2000

Information requested

  • Details of organisations licensed for using Fluorine-18 radioisotopes
  • Details of organisations holding a Medicines and Healthcare Products Regulatory Agency (MHRA) license (Specials license or Section 10 of the Medicines Act relating to Radiopharmaceutical products)

Information released

We have conducted a thorough search of our document management systems and can confirm that under Section 1 of the FOIA, we do not hold the information in scope of your request.

Further Information:

We are the UK’s independent nuclear regulator, with the legal authority to regulate nuclear safety, security, and conventional health and safety at 36 licensed nuclear sites in Great Britain. The medical administration to persons or animals of Fluorine-18 radioisotopes is not carried out on the sites we regulate; therefore we do not hold the information requested.

Details of organisations licensed for using Fluorine-18 radioisotopes

We are aware that there are a number of ‘licenses’ required in the UK for the medical administration of radioisotopes to persons or animals. For example a ‘Consent’ is required under the Ionising Radiations Regulations 2017 (IRR17)  for the ‘deliberate administration of radioactive substances to persons (and in some cases animals) for the purposes of medical or veterinary diagnosis, treatment or research’.

Such practices carried out in medical, veterinary, or research premises are regulated by the Health and Safety Executive (HSE) and they in turn would be responsible for issuing the required ‘Consents’. You may wish to contact them to obtain this information. Details of how to contact HSE are included on their website.

We note that you have also contacted MHRA in relation to this matter who should be able to assist you further.

Exemptions applied

N/A

PIT (Public Interest Test) if applicable

N/A