2015 No. 178
The Human Medicines (Amendment) Regulations 2015
Made
Laid before Parliament
Coming into force
The Secretary of State and the Minister for Health, Social Services and Public Safety make the following Regulations. They do so in the exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 19721, having been designated for the purposes of section 2(2) of that Act in relation to medicinal products2.
Citation and commencement1
These Regulations may be cited as the Human Medicines (Amendment) Regulations 2015 and shall come into force on 1st April 2015.
Amendment of the Human Medicines Regulations 20122
The Human Medicines Regulations 20123 are amended as follows.
Amendment of regulation 2133
1
Regulation 213 (interpretation for the purposes of Part 12) is amended as follows.
2
In paragraph (1)—
a
after the definition of “local authority”4 insert—
“Maritime and Coastguard Agency” means the executive agency of that name of the Department for Transport;
b
after the definition of “product subject to special medical prescription”5 insert—
“Public Health Agency” means the Regional Agency for Public Health and Social Well-being established by section 12 of the Health and Social Care (Reform) Act (Northern Ireland) 20096;
“Public Health England” means the executive agency of that name of the Department of Health;
Amendment of regulation 2294
1
Regulation 2297 (exemption for supply by national health service bodies and local authorities) is amended as follows.
2
In paragraph (1)—
a
in sub-paragraph (da) omit “or”;
b
after sub-paragraph (da) insert—
db
Public Health England;
dc
Public Health Agency; or
c
in sub-paragraph (f) for “(da)” substitute “(dc)”.
Amendment of regulation 2345
1
Regulation 234 (exemption for supply etc of products under a PGD to assist the police etc) is amended as follows.
2
In paragraph (2), for sub-paragraphs (c) and (d) substitute—
c
a prison service;
d
Her Majesty’s Forces; or
e
a contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency.
Amendment of regulation 3466
1
Regulation 3468 (Secretary of State to carry out a review of certain provisions) is amended as follows.
2
In paragraph (2)—
a
in sub-paragraph (c) after paragraph (xxviiie)9 insert—
xxviiif
229(1)(db) and (dc),
xxviiig
234(2)(e),
b
in sub-paragraph (d)—
i
after paragraph (iv)10 insert—
ivza
16, Part 2 entries relating to “Public Health England” and “Public Health Agency” and Part 3 entries relating to “search and rescue operations”,
ii
in paragraph (iva)11 omit “and”; and
iii
after paragraph (iva) insert—
ivb
22, entries relating to “Public Health England”, “Public Health Agency” and “search and rescue operations”, and
Amendment of Schedule 167
1
Schedule 16 (patient group directions) is amended as follows.
2
In the table in Part 212 (persons on whose behalf a patient group direction must be signed)—
a
after the row relating to Local Authority add—
Public Health England
The Chief Executive of Public Health England
Public Health Agency
The Public Health Agency
b
in the last row, in column 1—
i
in paragraph (dc) omit “or”; and
ii
after paragraph (dc) insert—
dd
Public Health England;
de
Public Health Agency; or
c
in the last row, in column 2—
i
in paragraph (cc) omit “or”; and
ii
after paragraph (cc) insert—
cd
Chief Executive of Public Health England,
ce
Public Health Agency, or
3
In the table in Part 3 (persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed), after the row relating to Her Majesty’s Forces add—
Contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency
Medical Director of the contractor carrying out search and rescue operations on behalf of the Maritime and Coastguard Agency
Amendment of Schedule 228
1
Schedule 2213 (classes of persons who may be supplied with medicinal products for the purposes of regulation 249) is amended as follows.
2
Before the first occurrence of “The Common Services Agency” insert—
Public Health England.
Public Health Agency.
3
For “(bc) a local authority; or” substitute—
bc
a local authority;
bd
Public Health England;
be
Public Health Agency; or
4
After “(c) a prison service;” omit “or”.
5
For “(d) Her Majesty’s Forces” substitute—
d
Her Majesty’s Forces; or
e
a contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency.
Signed by the authority of the Secretary of State
(This note is not part of the Regulations)