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

• Citation: S.I. 2005/768
• Sections: 3

Section 1 Citation, commencement and interpretation

(1) These Regulations may be cited as the Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005 and shall come into force on 7 th April 2005.

(2) In these Regulations, “the principal Regulations ” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 .

Section 2 Amendment of regulation 1 of the principal Regulations

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

(a) after the definition of “the EMEA” , 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 ;

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

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

“relevant register” means—

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

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

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 relating to—

chiropodists and podiatrists;

physiotherapists;

radiographers: diagnostic or therapeutic,

that register;

“supplementary prescriber” means—

a first level nurse,

a pharmacist,

a registered midwife, or

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—

chiropodists and podiatrists;

physiotherapists;

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.

Section 3 Amendment of Schedule 1 to the principal Regulations

In Schedule 1 to the principal Regulations (exemptions and exceptions from the provisions of regulation 3)—

(a) in paragraph 1, for “ or dentist”, substitute “, dentist or supplementary prescriber”

(b) in paragraph 2—

(i) in sub-paragraph (a), for “or dentist”, substitute “, dentist or supplementary prescriber”; and

(ii) in sub-paragraph (c), for “or dentist”, substitute “, dentist or supplementary prescriber”.