The Administration of Radioactive Substances Advisory Committee (ARSAC)
Regulation 2 of the Medicines (Administration of Radioactive Substances) Regulations 1978 (MARS Regulations 1978) requires that any doctor or dentist who wishes to administer radioactive medicinal products to humans should hold a certificate issued by Health Ministers. The Regulations also established a committee to advise Ministers on applications.
The term 'doctor' refers to a medically qualified practitioner as defined within the Medicines Act 1968.
The Administration of Radioactive Substances Advisory Committee (ARSAC) was set up to:
advise Health Ministers with respect to the grant, renewal, suspension, revocation and variation of certificates and generally in connection with the system of prior authorisation required by Article 5(a) of Council Directive 76/579/Euratom
The majority of committee members are medical doctors and are appointed by Ministers from within the UK as independent experts in their own field such as nuclear medicine. The chairman is a medical doctor - currently this is Dr Thomas Nunan, Nuclear Medicine consultant, St Thomas' Hospital, London.
The Committee normally meets twice a year. However the bulk of members' work is done throughout the year by post, advising the Health Departments on written applications from practitioners for certificates which will enable them to use specific radioactive medicinal products in diagnosis, therapy or research.
Applicants for certificates supply information in confidence to the ARSAC Support Unit in order that they can be assessed for their suitability to hold a certificate. Applicants are normally of consultant status and supply information on their training and experience as well as on the services (such as radiopharmacies and medical physics departments) that support them.
The Committee comments on such applications in confidence to the Support Unit. The information accumulated on individual applications is considered by a Department of Health official and if the application is successful the certificate is authorised on behalf of Secretary of State by that official.
All applications should be submitted with original signatures to the ARSAC Support Unit
Please note that following the publication of the new Notes for Guidance in March 2006 the format of application forms has changed. Application forms are available on this website.
Please note that completed applications in the previous format will not be accepted after 1/7/2006
PLEASE NOTE THAT NO APPLICATIONS WILL BE ACCEPTED BY EMAIL
The HPA on behalf of ARSAC publish "Notes for Guidance on the Clinical Administration of Radiopharmaceuticals and Use of Sealed Sources". The current version; March 2006 is currently available on this website.
The guidance given in the Notes is not mandatory and does not have the force of statutory regulations: nevertheless, it is based on national and international recommendations and represents the advice of ARSAC. These Notes can be considered to be a guide to good clinical practice in the UK for nuclear medicine. The Notes will be updated periodically as appropriate and some detailed updating will be provided through a Newsletter and published on this website.
The current membership of ARSAC is available online.
No individual ARSAC member is responsible for authorising any individual application. Therefore there is no basis to contact directly members for advice. Queries regarding applications may be referred to the ARSAC Support Unit.
Any contact with the Committee, as a whole, should be made through the ARSAC Secretariat. Contact details are available on this website