2007 No. 2178
The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007
Made
Laid before Parliament
Coming into force
The Secretary of State and the Minister for Health, Social Services and Public Safety, acting jointly, make the following Order in the exercise of powers conferred upon them by sections 57(1) and (2), 58(4) and (5) and 129(4) of the Medicines Act 19681, or, in the case of the Minister, the powers conferred by those provisions and now vested in him2.
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 this Order. In accordance with sections 58(6) and 129(7) of that Act, they have consulted and taken into account the advice of the Commission on Human Medicines3.
Citation, commencement and interpretation1
1
This Order may be cited as the Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 and shall come into force on 1st September 2007.
Amendment of article 1 of the POM Order2
1
Article 1 of the POM Order (citation, commencement and interpretation) is amended as follows.
2
In paragraph (2)—
a
in the definition of “independent clinic”—
i
in paragraph (b), for “2001;” substitute “2001, and”, and
ii
after paragraph (b) insert—
c
in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 20036;
b
in the definition of “independent hospital”—
i
in paragraph (b), for “2001;” substitute “2001, and”, and
ii
after paragraph (b) insert—
c
in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
c
in the definition of “independent medical agency”—
i
in paragraph (b), for “2001;” substitute “2001, and”, and
ii
after paragraph (b) insert—
c
in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
d
in the definition of “nursing home”, for the words from “article 16” to the end of the paragraph substitute “article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003”;
e
in the definition of “Patient Group Direction”—
i
in paragraph (a)—
aa
after “with the” insert “sale or”, and
bb
for “supply and administration” substitute “sale or supply, and administration,”, and
ii
in sub-paragraph (ii), after “relates to” insert “sale or”;
f
in the definition of “registered provider”—
i
in paragraph (a), after sub-paragraph (ii) insert—
iii
in relation to Northern Ireland, the person registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person carrying on the establishment or agency, and
ii
for paragraph (b), substitute—
b
in relation to a nursing home, the person registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person carrying on the establishment;
g
in the definition of “relevant manager”—
i
in paragraph (a), after sub-paragraph (ii) insert—
iii
in relation to Northern Ireland—
aa
a person who is registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or
bb
if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person, and
ii
for paragraph (b), substitute—
b
in relation to a nursing home—
i
a person who is registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or
ii
if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person;
3
In paragraph (8)—
a
after “arrangement for the” insert “sale,”; and
b
after “such” insert “sale,”.
Amendment of article 12C of the POM Order3
In article 12C of the POM Order (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a patient group direction)—
a
in paragraph (1)—
i
after “apply to the” insert “sale or”,
ii
for sub-paragraph (a) substitute the following paragraph—
a
the medicine—
i
is supplied, or as the case may be, is administered by such a person pursuant to an arrangement made with—
aa
a body referred to in article 12A(a) to (d),
bb
a force or service referred to in article 12E(1)(a)(i) to (iii), or
cc
Her Majesty’s Forces,
for the supply or, as the case may be, the administration of prescription only medicines; or
ii
is sold or supplied or, as the case may be, is administered by such a person pursuant to an arrangement made with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1) for the sale or supply or, as the case may be, the administration of prescription only medicines;
iii
in sub-paragraph (b), after “medicine is” insert “sold or”; and
b
in paragraph (2)—
i
in sub-paragraph (a)—
aa
after “relates to the” insert “sale or”,
bb
after “who” insert “sells or”, and
cc
after “medicine is” insert “sold or”, and
ii
in sub-paragraph (d), after “medicine is” insert “sold or”.
Amendment of article 12D of the POM Order4
In article 12D of the POM Order (exemption for the supply and administration of prescription only medicines in independent hospitals, clinics and agencies)—
a
in paragraph (1)—
i
after “apply to the” insert “sale or”,
ii
for sub-paragraphs (a) and (b) substitute—
a
an independent hospital,
b
an independent clinic,
c
an independent medical agency, or
d
in Northern Ireland, a nursing home,
iii
after “medicine is” insert “sold or”; and
b
in paragraph (2)—
i
in sub-paragraph (a)—
aa
after “relates to the” insert “sale or”,
bb
after “who” insert “sells or”, and
cc
after “medicine is” insert “sold or”,
ii
in sub-paragraph (d)—
aa
after “the individual who” insert “sells or” and
bb
after “purpose of the” insert “sale or”, and
iii
in sub-paragraph (e), after “medicine is” insert “sold or”.
Amendment of Schedule 7 to the POM Order5
In Schedule 7 to the POM Order, in Part 1 (particulars to be included in a patient group direction), in paragraph (c), after “may be” insert “sold or”.
Amendment of article 1 of the Pharmacy and General Sale Order6
In article 1 of the Pharmacy and General Sale Order (citation, commencement and interpretation), in paragraph (2), in sub-paragraph (a)—
a
in the definition of “independent clinic”—
i
in paragraph (b), for “2001;” substitute “2001, and”, and
ii
after paragraph (b), insert—
c
in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
b
in the definition of “independent hospital”—
i
in paragraph (b), for “2001;” substitute “2001, and”, and
ii
after paragraph (b) insert—
c
in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
c
in the definition of “independent medical agency”—
i
in paragraph (b), for “2001;” substitute “2001, and”, and
ii
after paragraph (b) insert—
c
in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
d
in the definition of “nursing home”, for the words from “article 16” to the end of the paragraph substitute “article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003”;
e
in the definition of “Patient Group Direction”—
i
for “supply and administration” substitute “sale or supply, and administration,”, and
ii
in paragraph (b), after “relates to” insert “sale or”;
f
in the definition of “registered provider”—
i
in paragraph (a), after sub-paragraph (ii) insert—
iii
in relation to Northern Ireland, the person registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person carrying on the establishment or agency, and
ii
for paragraph (b), substitute—
b
in relation to a nursing home, the person registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person carrying on the establishment;
g
in the definition of “relevant manager”—
i
in paragraph (a), after sub-paragraph (ii) insert—
iii
in relation to Northern Ireland—
aa
a person who is registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or
bb
if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person, and
ii
for paragraph (b), substitute—
b
in relation to a nursing home—
i
a person who is registered under Part III of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or
ii
if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person;
Amendment of article 4C of the Pharmacy and General Sale Order7
In article 4C of the Pharmacy and General Sale Order (exemption for the supply of medicinal products by independent hospitals, clinics and agencies)—
a
in the heading, after “the” insert “sale or”;
b
in paragraph (1)—
i
after “apply to the” insert “sale or”,
ii
for sub-paragraphs (a) and (b) substitute—
a
an independent hospital,
b
an independent clinic,
c
an independent medical agency, or
d
in Northern Ireland, a nursing home,
iii
after “product is” insert “sold or”; and
c
in paragraph (2)—
i
in sub-paragraph (a)—
aa
after “relates to the” insert “sale or”,
bb
after “medicinal product is” insert “sold or”, and
cc
after “the product is” insert “sold or”,
ii
in sub-paragraph (d)—
aa
after “the individual who” insert “sells or”, and
bb
after “purpose of the” insert “sale or”, and
iii
in sub-paragraph (e), after “product is” insert “sold or”.
Amendment of Schedule 3 to the Pharmacy and General Sale Order8
In Schedule 3 to the Pharmacy and General Sale Order, in Part 1 (particulars to be included in a patient group direction), in paragraph (d), after “may be” insert “sold or”.
Signed by authority of the Secretary of State for Health
(This note is not part of the Order)