The Medicines (Administration of Radioactive Substances) Amendment Regulations 1995

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Medicines (Administration of Radioactive Substances) Regulations 1978 (“the 1978 Regulations”), which prohibit the administration of radioactive medicinal products except by doctors or dentists holding a certificate issued by the Health Ministers (as defined in the Medicines Act 1968) or persons acting under the directions of such a doctor or dentist. The 1978 Regulations also make provision for the grant, duration, renewal, suspension, variation and revocation of certificates, for the appointment of an advisory committee (the Administration of Radioactive Substances Advisory Committee) and for various procedural matters.

The 1978 Regulations were made in pursuance of Council Directive 76/579/Euratom and implement Article 5(a) of that Directive, which provides that a system of prior authorization must be applied in respect of the administration of radioactive substances to persons for the purposes of diagnosis, treatment or research.

These Regulations make provision for—

(a) directions and notices to be given in writing (regulation 2(2));

(b) the grant of further certificates, to authorise the administration of descriptions or classes of radioactive substances for the purpose of diagnosis or treatment of persons specified in those certificates, to those doctors and dentists who already hold certificates (regulation 2(3) and (4));

(c) the administration of descriptions and classes of radioactive medicinal products under those further certificates to particular patients (regulation 2(3));

(d) the giving of written particulars to a doctor or dentist about the suspension, revocation or variation of his certificate (regulation 2(5));

(e) the cessation of certain procedural requirements where a certificate is varied to include a description or class of radioactive medicinal product which was included in the application for that certificate (regulation 2(6));

(f) the functions of Health Ministers under the 1978 Regulations to be performed by any one of them or by any two or more of them acting jointly (regulation 2(7));

(g) the application of section 67(2) and (4) and Part VIII of that Act (provisions which relate to offences etc.) to the 1978 Regulations (also regulation 2(7)).