2006 No. 2806
The Medicines (Administration of Radioactive Substances) Amendment Regulations 2006
Made
Laid before Parliament
Coming into force
The Secretary of State and the Department of Health, Social Services and Public Safety, acting jointly, make the following Regulations in the exercise of powers conferred upon them by sections 60(2) and 129(5) of the Medicines Act 19681, or, in the case of the Department, the powers conferred by those provisions and now vested in it2.
In so far as these Regulations are not made under section 60(2) and 129(5) of the Medicines Act 1968, the Secretary of State makes these Regulations in exercise of the powers conferred upon her by section 2(2) of the European Communities Act 19723. The Secretary of State has been designated for the purposes of section 2(2) in relation to medicinal products4.
In accordance with section 129(6) of the Medicines Act 1968, the Secretary of State and the Department of Health, Social Services and Public Safety have consulted such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations. In accordance with sections 60(7) and 129(7) of that Act, they have consulted and taken into account the advice of the Commission on Human Medicines5.
Citation, commencement and interpretation1
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 19786.
Amendment of regulation 1 of the principal Regulations2
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 20007;
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 Regulations3
For regulation 2 of the principal Regulations (control of administration) substitute the following regulation—
Control of administration2
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.
Signed by authority of the Secretary of State for Health
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
(This note is not part of the Regulations)