Statutory Instruments
2005 No. 768
MEDICINES
The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005
Made
16th March 2005
Laid before Parliament
17th March 2005
Coming into force
7th April 2005
Citation, commencement and interpretation
1. —(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( 3 ).
Amendment of regulation 1 of the principal Regulations
2. In regulation 1 of the principal Regulations (citation, commencement and extent)—
(a) after the definition of “the EMEA”( 4 ), 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 ( 5 ) ;
“registered midwife” means a person registered in the Midwives' Part of the professional register; ” ;
(c) after the definition of “relevant medicinal product”( 6 ), 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 ( 7 ) or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 ( 8 ) ; 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 ( 9 ) 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. ” .
Amendment of Schedule 1 to the principal Regulations
3. 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”.
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State,
Department of Health
16th March 2005
S.I. 1994/3144 ; relevant amending instruments are S.I. 2002/236 and 2004/865 , 1016 and 1031 .
The definition of “EMEA” was substituted by S.I. 2004/3224 .
The definition of “relevant medicinal product” was substituted by S.I. 2002/236 .
OJ No. L311, 28.11.2001, p.34.