The Human Medicines (Amendment) (No. 3) Regulations 2015

• Citation: S.I. 2015/1503
• Sections: 10

Section 1 Citation and commencement

These Regulations may be cited as the Human Medicines (Amendment) (No. 3) Regulations 2015 and shall come into force on 1st October 2015.

Section 2 Amendment of the Human Medicines Regulations 2012

The Human Medicines Regulations 2012 are amended as follows.

Section 3 Amendment of regulation 8

(1) Regulation 8 (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)”.

Section 4 Amendment of regulation 38

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”.

Section 5 Amendment of regulation 39

In regulation 39 (further requirements for manufacturer’s licence), in paragraph (8), for “44(4) to (6)” substitute “44(5) and (6)”.

Section 6 Amendment of regulation 44

(1) Regulation 44 (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”.

Section 7 Amendment of regulation 233

(1) Regulation 233 (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”.

Section 8 Amendment of regulation 256E

In regulation 256E (removal of a person’s entry from the list), in paragraph (a), for “256I(1)(b)” substitute “256I(1)(c)”.

Section 9 Amendment of regulation 346

(1) Regulation 346 (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 (xxviiif) insert—

(xxviiifa)

233(1)(a)(ivd) and (ive),

(b) in sub-paragraph (d), for paragraph (iva) substitute—

(iva) 17, Part 1 item 12, Part 2 items 4a and 11, Part 4 items 11 and 12 and Part 5 items 7a and 18,

Section 10 Amendment of Schedule 17

(1) Schedule 17 (exemption for sale, supply or administration by certain persons) is amended as follows.

(2) In Part 2 (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.

(3) In Part 5 (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.