2015 No. 1503
The Human Medicines (Amendment) (No. 3) 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) (No. 3) Regulations 2015 and shall come into force on 1st October 2015.
Amendment of the Human Medicines Regulations 20122
The Human Medicines Regulations 20123 are amended as follows.
Amendment of regulation 83
1
Regulation 84 (general interpretation) is amended as follows.
2
In paragraph (2), for “18(7) and (8)” substitute “18(4) and (5)”;
3
In paragraph (3), for “18(8)” substitute “18(5)”; and
4
In paragraph (4), for “18(8)” substitute “18(5)”.
Amendment of regulation 384
In regulation 38 (imports from states other than EEA states), in paragraph (3)(b), for the words from “the principles” to the end substitute “good manufacturing practice for active substances”.
Amendment of regulation 395
In regulation 395 (further requirements for manufacturer’s licence), in paragraph (8), for “44(4) to (6)” substitute “44(5) and (6)”.
Amendment of regulation 446
1
Regulation 446 (requirements for wholesale dealers to deal only with specified persons) is amended as follows.
2
Omit paragraph (1).
3
In paragraph (2)—
a
for “From 28th October 2013 the” substitute “The”;
b
after sub-paragraph (b), insert “or”;
c
in sub-paragraph (c), for “country A; or” (at the end of the sub-paragraph) substitute “country A.”;
d
omit sub-paragraph (d).
4
In paragraph (3), omit “(1),”.
5
Omit paragraph (4).
6
In paragraph (5), for “From 28th October 2013, the” substitute “The”.
Amendment of regulation 2337
1
Regulation 2337 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) is amended as follows.
2
In paragraph (1)(a), after paragraph (ivc) insert—
ivd
Public Health England,
ive
Public Health Agency,
3
In paragraph (5), in sub-paragraph (a) for “to (ivc) (health bodies), on behalf of that body” substitute “to (ive) (health bodies), by or on behalf of the person specified in column 2 of Part 2 of Schedule 16 against the entry in column 1 for that body”.
Amendment of regulation 256E8
In regulation 256E8 (removal of a person’s entry from the list), in paragraph (a), for “256I(1)(b)” substitute “256I(1)(c)”.
Amendment of regulation 3469
1
Regulation 3469 (Secretary of State to carry out a review of certain provisions) is amended as follows.
Amendment of Schedule 1710
1
Schedule 17 (exemption for sale, supply or administration by certain persons) is amended as follows.
2
In Part 212 (exemption from the restriction on supply of prescription only medicines), after item 4 in the table add—
4a Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies– (a) an NHS body; (b) a local authority; (c) Public Health England; or (d) Public Health Agency. | 4a A prescription only medicine for parenteral administration containing naloxone hydrochloride but no other substance that is classified as a product available on prescription only. | 4a The supply shall be only in the course of provisions of lawful drug treatment services and only where required for the purpose of saving life in an emergency. |
3
In Part 513 (exemptions from the restrictions in regulation 220 and 221 for certain persons who supply certain medicinal products), after item 7 in the table add—
7a Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies– (a) an NHS body; (d) a local authority; (c) Public Health England; or (d) Public Health Agency. | 7a A prescription only medicine for parenteral administration containing naloxone hydrochloride but no other substance that is classified as a product available on prescription only. | 7a The supply shall be only in the course of provisions of lawful drug treatment services and only where required for the purpose of saving life in an emergency. |
Signed by the authority of the Secretary of State.
(This note is not part of the Regulations)