Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Medicines (Administration of Radioactive Substances) Amendment Regulations 2006 and shall come into force on 17th November 2006.

(2) In these Regulations “the principal Regulations” means the Medicines (Administration of Radioactive Substances) Regulations 1978(6).

Amendment of regulation 1 of the principal Regulations

2.  In regulation 1 of the principal Regulations (citation, commencement and interpretation), in paragraph (2)—

(a)after the definition of “directions”, insert the following definition—

““medical exposure” has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000(7);” and

(b)after the definition of “notice”, insert the following definitions—

““operator” has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000;

“practitioner” has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000;”

Substitution of regulation 2 of the principal Regulations

3.  For regulation 2 of the principal Regulations (control of administration) substitute the following regulation—

“Control of administration

2.—(1) No person shall administer to a human being (otherwise than to himself) any radioactive medicinal product unless he is a doctor or a dentist holding a certificate issued by the Ministers for the purposes of section 60 of the Act in respect of radioactive medicinal products (hereinafter referred to as a “certificate”) or a person acting in accordance with the directions of such a doctor or dentist.

(2) Paragraph (1) does not apply where the administration of a radioactive medicinal product would result in a medical exposure and the conditions specified in paragraph (3) are satisfied.

(3) The conditions referred to in paragraph (2) are that—

(a)the medicinal product is administered by an operator acting in accordance with the procedures and protocols referred to in regulation 4(1) and (2) of the Ionising Radiation (Medical Exposure) Regulations 2000 which apply to the exposure referred to in paragraph (1);

(b)that medical exposure has been authorised by a practitioner or, where it is not practicable for a practitioner to authorise the exposure, an operator acting in accordance with written guidelines issued by a practitioner;

(c)the practitioner is the holder of a certificate; and

(d)the medicinal product is not a controlled drug.

(4) Where a certificate is issued to a doctor or dentist specifying particular descriptions or classes of radioactive medicinal products—

(a)the doctor or dentist holding the certificate;

(b)any person acting in accordance with his directions; and

(c)an operator acting pursuant to his authorisation of a medical exposure or in accordance with his guidelines,

shall not administer any radioactive medicinal product unless it is a radioactive medicinal product of a description or falling within a class specified in the certificate.

(5) Where, in relation to a radioactive medicinal product specified in a certificate, the purpose for which the administration is also specified—

(a)the doctor or dentist holding the certificate;

(b)any person acting in accordance with his directions; and

(c)an operator acting pursuant to his authorisation of a medical exposure or in accordance with his guidelines,

shall not administer any radioactive medicinal product unless it is a radioactive medicinal product of a description or falling within a class specified in the certificate.

(6) Where a certificate issued to a doctor or dentist specifies both the persons to whom any descriptions or classes of radioactive medicinal product may be administered, and the descriptions or classes of radioactive medicinal product which may be administered—

(a)the doctor or dentist;

(b)any person acting in accordance with his directions; and

(c)an operator acting pursuant to his authorisation of a medical exposure, or in accordance with his guidelines,

shall not under that certificate administer any such description or classes of radioactive medicinal product except for the purpose of diagnosis or treatment of a person specified in that certificate.”

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Medicines (Administration of Radioactive Substances) Regulations 1978 (“the principal Regulations”) which restrict the administration of radioactive medicinal products and implement a system of prior authorisation for administration of radioactive substances under Directive 76/579/Euratom(8) (that Directive is no longer in force; the relevant provisions are now in Directive 96/29/Euratom(9)).

Regulation 2 of the principal Regulations prohibits administration of radioactive medicinal products except by a doctor or dentist who holds the relevant certificate issued by the Ministers (“the certificate holder”) or by a person acting in accordance with his directions and makes other provisions relating to administration. Regulations 2 and 3 of these Regulations amend the principal Regulations in order to provide that radioactive medicinal products may be administered by a person who is not a certificate holder in the absence of such directions, in specified circumstances, where the administration involves a medical exposure under the Ionising Radiation (Medical Exposure) Regulations 2000 (“the IRME Regulations”). In particular, regulation 3 substitutes a new regulation 2 of the principal Regulations, so as to make provision for persons who are operators under the IRME Regulations to administer radioactive medicinal products. The operator must be acting in accordance with the relevant procedures and protocols under the IRME Regulations. In addition, he must be acting under the authorisation of, or in accordance with guidelines issued by, a person who is a practitioner under those Regulations and also a certificate holder.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Copies of the assessment have been placed in the libraries of both Houses of Parliament.