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The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005

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Amendment of regulation 1 of the principal Regulations

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

(a)after the definition of “the EMEA”(1), insert the following definition—

“first level nurse” means a person registered in Sub-Part 1 of the Nurses' Part of the professional register;;

(b)after the definition of “parallel import license”, insert the following definitions—

“professional register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001(2);

“registered midwife” means a person registered in the Midwives' Part of the professional register;;

(c)after the definition of “relevant medicinal product”(3), insert the following definitions—

“relevant register” means—

(a)

in relation to a first level nurse or registered midwife, the professional register;

(b)

in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954(4) or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976(5); and

(c)

in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001(6) relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists;

(iii)

radiographers: diagnostic or therapeutic,

that register;

“supplementary prescriber” means—

(a)

a first level nurse,

(b)

a pharmacist,

(c)

a registered midwife, or

(d)

a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001relating to—

(i)

chiropodists and podiatrists;

(ii)

physiotherapists;

(iii)

radiographers: diagnostic or therapeutic,

against whose name is recorded in the relevant register, an annotation or entry signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber..

(1)

The definition of “EMEA” was substituted by S.I. 2004/3224.

(3)

The definition of “relevant medicinal product” was substituted by S.I. 2002/236.

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