Statutory Instruments
2006 No. 914
MEDICINES
The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2006
Made
23rd March 2006
Laid before Parliament
3rd April 2006
Coming into force
1st May 2006
The Secretary of State for Health 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 66(1), 87(1), 91(2) and 129(5) of the Medicines Act 1968( 1 ), or as the case may be, the powers conferred by those provisions and now vested in them( 2 ).
In accordance with section 129(6) of that Act, they have consulted such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations. In accordance with section 129(7) of that Act, they have consulted and taken into account the advice of the Committee on Safety of Medicines( 3 ).
In so far as these Regulations are not made under the Medicines Act 1968, the Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972( 4 ). The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act in relation to medicinal products( 5 ).
Citation, commencement and interpretation
1. —(1) These Regulations may be cited as the Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2006 and shall come into force on 1st May 2006.
(2) In these Regulations—
“the Sale or Supply Regulations” means the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980( 6 );
“the Marketing Authorisations Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994( 7 );
“the Child Safety Regulations” means the Medicines (Child Safety) Regulations 2003( 8 ); and
“the Traditional Herbal Medicinal Products Regulations” means the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005( 9 ).
Amendment of the Sale or Supply Regulations
2. —(1) The Sale or Supply Regulations shall be amended as follows.
(2) In regulation 1 (citation, commencement and interpretation), in paragraph (2)—
(a) after the definition of “additional supply optometrist” insert the following definition—
“ “community practitioner nurse prescriber” means a person—
who is a registered nurse or a registered midwife, and
against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Formulary for Community Practitioners in the current edition of the British National Formulary; ” ;
(b) omit the definition of “district nurse/health visitor prescriber”;
(c) omit the definition of “Extended Formulary”;
(d) omit the definition of “extended formulary nurse prescriber”;
(e) omit the definition of “first level nurse”;
(f) in the definition of “health prescription”, for “a district nurse/health visitor prescriber or an extended formulary nurse prescriber” substitute “a community practitioner nurse prescriber, a nurse independent prescriber or a pharmacist independent prescriber”;
(g) after the definition of “independent medical agency” insert the following definition—
“ “nurse independent prescriber” means a person—
who is a registered nurse or a registered midwife, and
against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances as a nurse independent prescriber or a nurse independent/supplementary prescriber; ” ;
(h) after the definition of “parenteral administration” insert the following definition—
“ “pharmacist independent prescriber” means a person—
who is a pharmacist, and
against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber; ” ;
(i) after the definition of “professional register” insert the following definitions—
“ “registered midwife” means a person registered in the Midwives' Part of the professional register;
“registered nurse” means a person registered in the Nurses' Part or Specialist Community Public Health Nurses' Part of the professional register; ” ;
(j) in the definition of “relevant register”, in paragraph (a), for “first level” substitute “registered”; and
(k) in the definition of “supplementary prescriber”—
(i) in paragraph (a), for “first level” substitute “registered”, and
(ii) after “a supplementary prescriber” insert “or, in the case of a nurse or midwife, as a nurse independent/supplementary prescriber”.
(3) In Schedule 2 (particulars in pharmacy records), in paragraph 1—
(a) for “a district nurse/health visitor prescriber or an extended formulary nurse prescriber” substitute “a community practitioner nurse prescriber, a nurse independent prescriber or a pharmacist independent prescriber”; and
(b) in sub-paragraph (c), for “district nurse/health visitor prescriber or extended formulary nurse prescriber” substitute “community practitioner nurse prescriber, nurse independent prescriber or pharmacist independent prescriber”.
Amendment of the Marketing Authorisations Regulations
3. In regulation 1 of the Marketing Authorisations Regulations (citation, commencement and interpretation), in paragraph (2)—
(a) omit the definition of “first level nurse”;
(b) after the definition of “registered midwife” insert the following definition—
“ “registered nurse” means a person registered in the Nurses' Part or Specialist Community Public Health Nurses' Part of the professional register; ” ;
(c) in the definition of “relevant register”, in paragraph (a), for “first level” substitute “registered”; and
(d) in the definition of “supplementary prescriber”—
(i) in paragraph (a), for “first level” substitute “registered”, and
(ii) after “a supplementary prescriber” insert “or, in the case of a nurse or midwife, as a nurse independent/supplementary prescriber”.
Amendment of the Child Safety Regulations
4. —(1) The Child Safety Regulations shall be amended as follows.
(2) In regulation 1 (citation, commencement and interpretation), in paragraph (2)—
(a) omit the definition of “first level nurse”;
(b) in the definition of “nurse prescriber”—
(i) in paragraph (a), for “first level” substitute “registered”, and
(ii) in paragraph (b), after “appliances” insert “as a community practitioner nurse prescriber, a nurse independent prescriber or a nurse independent/supplementary prescriber”;
(c) after the definition of “nurse prescriber” insert the following definition—
“ “pharmacist independent prescriber” means a person—
who is a pharmacist, and
against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber; ” ;
(d) after the definition of “professional register” insert the following definitions—
“ “registered midwife” means a person registered in the Midwives' Part of the professional register;
“registered nurse” means a person registered in the Nurses' Part or Specialist Community Public Health Nurses' Part of the professional register; ” ;
(e) in the definition of “relevant register”, in paragraph (a), for “first level” substitute “registered”; and
(f) in the definition of “supplementary prescriber”—
(i) in paragraph (a), for “first level” substitute “registered”, and
(ii) after “a supplementary prescriber” insert “or, in the case of a nurse or midwife, as a nurse independent/supplementary prescriber”.
(3) In regulation 3 (exemptions from regulation 2), in paragraph (1), in sub-paragraph (a), after “supplementary prescriber” insert “, pharmacist independent prescriber”.
Amendment of the Traditional Herbal Medicinal Products Regulations
5. In Schedule 1 to the Traditional Herbal Medicinal Products Regulations (exemptions and exceptions from the provisions of regulation 4), in paragraph 1 (interpretation)—
(a) omit the definition of “first level nurse”;
(b) after the definition of “registered midwife” insert the following definition—
“ “registered nurse” means a person registered in the Nurses' Part or Specialist Community Public Health Nurses' Part of the professional register; ” ;
(c) in the definition of “relevant register”, in paragraph (a), for “first level” substitute “registered”; and
(d) in the definition of “supplementary prescriber”—
(i) in paragraph (a), for “first level” substitute “registered”, and
(ii) after “as a supplementary prescriber” insert “or, in the case of a nurse or midwife, as a nurse independent/supplementary prescriber”.
Signed by authority of the Secretary of State for Health
Jane Kennedy
Minister of State,
Department of Health
23rd March 2006
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
Andrew McCormick
Permanent Secretary,
Department of Health, Social Services and Public Safety
16th March 2006
1968 c. 67 . The expression “the appropriate Ministers” and the expression “the Health Ministers”, which are relevant to the powers being exercised in the making of these Regulations, are defined in section 1 of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 , and by articles 2(1) and 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142 , and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794 .
In the case of the Secretary of State for Health, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388 , and articles 2(1) and 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142 ; and in the case of the Department of Health, Social Services and Public Safety, by virtue of the powers vested in the Ministers in charge of that Department by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) , which may now be exercised by the Department by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1) ; the Department was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1.) .
See paragraph 1 of Part 2 of Schedule 5 to S.I. 2005/2754 .
S.I. 1980/1923 ; relevant amending instruments are S.I. 2003/698 , 2004/1771 , 2005/764 , 1520 and 2745 .
S.I. 1994/3144 ; relevant amending instruments are S.I. 2005/768 and 1520 .
S.I. 2003/2317 , amended by S.I. 2004/1771 and 2005/1520 .
OJ No. L311, 28.11.2001, p34.
OJ No. L136, 30.3.2004, p85.