Paragraph 5

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

Sch 1, paras 1, 2 am by Medicines for Human Use (Marketing Authorisations Etc.) 2005 reg 3
Sch. 1 para. 3(1)(a) words substituted by General Medical Services and Personal Medical Services Transitional and Consequential Provisions 2004 Sch. 1 para. 12
Sch. 1 para. 3(1)(a) words substituted by General Dental Services, Personal Dental Services and Abolition of the Dental Practice Board Transitional and Consequential Provisions 2006 Sch. 1 para. 4
sch 1 am by Medicines for Human Use 2009 reg 2
Sch. 1 para. 2(b) words revoked by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 Sch. 5 para. 2
Sch. 1 para. 2(e) substituted by Medicines for Human Use (Clinical Trials) 2004 Sch. 10 Pt. 2 para. 12(b)
Sch. 1 para. 1 words inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(13)(a)
Sch. 1 para. 2(e) substituted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(13)(b)
Sch. 1 para. 5A inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(13)(c)
Sch. 1 para. 3(1)(a) words substituted by General Medical Services Transitional and Consequential Provisions 2004 Sch. 1 para. 12
Sch. 1 para. 2(e) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(f)

(1)

Regulations 3(1) shall not apply to a radiopharmaceutical for human use^f1 —

(a)

which is prepared at the time at which it is intended to be administered; and

(b)

which is prepared, in accordance with the manufacturer’s instructions and by the person by whom it is to be administered, exclusively from a kit, generator or precursor (or from more than one of these) in respect of which a marketing authorization is in force; and

(c)

the administration of which is not or will not be a contravention of regulation 2 of the Medicines (Administration of Radioactive Substances) Regulations 1978^f2.

(2)

In this paragraph—

“generator” means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and is to be used in a radiopharmaceutical;
“kit” means any preparation to be reconstituted or combined with radionuclides in a final radiopharmaceutical, usually prior to its administration;
“precursor” means a radionuclide produced for the radio-labelling of another substance prior to its administration, other than a radionuclide which is incorporated in or produced from a generator or is included in a radiopharmaceutical;
“radiopharmaceutical” means any relevant medicinal product which when ready for use contains one or more radionuclides included for a medicinal purpose.

Annotations

Footnotes

f1: See article 2 of Council Directive 89/343/EEC.
f2: S.I. 1978/1006.