EXPLANATORY NOTE

These Regulations prohibit the administration of radioactive medicinal products except by doctors or dentists holding a certificate issued by the Health Ministers in respect of radioactive medicinal products or persons acting under the directions of such a doctor or dentist. The Regulations also—

(1)include provision as to the grant, duration, renewal, suspension, variation and revocation of certificates,

(2)provide for the appointment of a committee to advise the Health Ministers, and

(3)provide a procedure enabling applicants for or holders of a certificate to make representations in writing or to be heard by a person appointed before a certificate is refused, suspended, varied or revoked as the case may be.

The Regulations are made in pursuance of Council Directive 76/579/Euratom which lays down the revised standards for the health protection of the general public and workers against the dangers of ionising radiation. They implement Article 5(a) of the Directive which provides that a system of prior authorisation must be applied in respect of the administration of radioactive substances to persons for the purposes of diagnosis, treatment or research.