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Statutory Instruments

2017 No. 715

Medicines

The Human Medicines (Amendment) Regulations 2017

Made

29th June 2017

Laid before Parliament

5th July 2017

Coming into force

1st October 2017

The Secretary of State and the Department of Health in Northern Ireland(1) make the following Regulations. They do so in exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 1972(2), having been designated for the purposes of section 2(2) of that Act in relation to medicinal products(3).

Citation and commencement

1.  These Regulations may be cited as the Human Medicines (Amendment) Regulations 2017 and shall come into force on 1st October 2017.

Amendment of the Human Medicines Regulations 2012

2.  The Human Medicines Regulations 2012(4) are amended as follows.

Amendment of regulation 8 (general interpretation)

3.—(1) Regulation 8(5) is amended as follows.

(2) In paragraph (1)—

(a)in the appropriate place, insert—

“external use” in relation to a medicinal product—

(a)

means its use by application to the skin, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal in circumstances where local action only is necessary and systemic absorption is unlikely to occur; but

(b)

does not include its use by means of a throat spray, nasal spray, nasal inhalation or teething preparation or by means of throat pastilles, throat lozenges, throat tablets or nasal drops;; and

(b)in the definition of “the relevant register”, in paragraph (d)—

(i)after “ a physiotherapist” insert “, an orthoptist”;

(ii)in sub-paragraph (ii) omit “or”; and

(iii)after sub-paragraph (iii) insert—

, or

(iv)

orthoptists;.

Amendment of regulation 45B (application for brokering registration)

4.  In regulation 45B(6), in paragraph (1), after “unless paragraphs” insert “(2)”.

Amendment of regulation 167 (supply to fulfil special patient needs)

5.—(1) Regulation 167 is amended as follows.

(2) In paragraph (7)—

(a)in sub-paragraph (b), at the end, for the full stop substitute a comma; and

(b)after sub-paragraph (b) insert (as full out words)—

and it is imported by the holder of a wholesale dealer’s licence in relation to the product in question..

Amendment of regulation 213 (interpretation of Part 12)

6.  In regulation 213(7), in paragraph (1), omit the definition of “external use”.

Amendment of regulation 346 (Secretary of State to carry out a review of certain provisions)

7.  In regulation 346(8), in paragraph (2)(d)(iva), after “Part 2 items 4a, 11 and 12,” insert “Part 3 item 11,”.

Amendment of Schedule 17 (exemption for sale, supply or administration by certain persons)

8.—(1) Schedule 17 is amended as follows.

(2) In the table in Part 1(9) (exemption from restrictions on sale and supply of prescription only medicines)—

(a)in item 12—

(i)for the words in column 2 substitute—

Prescription only medicines comprising:

(a)

an inhaler containing salbutamol; or

(b)

an auto-injector containing adrenaline; and

(ii)in column 3, after “for the purpose of supplying” insert “or administering”; and

(b)in item 13, in column 1, after “Registered orthoptists” insert “against whose names are recorded in the relevant register annotations signifying that they are qualified to sell or supply the medicine specified in column 2”.

(3) In the table in Part 3(10) (exemptions from the restriction on administration of prescription only medicines), after item 10 in the table insert—

11 A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine.11 A prescription only medicine comprising an auto-injector containing adrenaline.

11 The administration shall be—

(a) in the course of P carrying on the business of

a school;

(b) where administration is to a pupil at that school who is known to be at risk of anaphylaxis; and

(c) where the pupil requires the medicinal product in an emergency.

(4) In the table in Part 4(11) (exemption for certain persons who sell or supply certain medicinal products), in item 13, in column 1, after “Registered orthoptists” insert “against whose names are recorded in the relevant register annotations signifying that they are qualified to sell or supply the medicine specified in column 2”.

Signed by the authority of the Secretary of State.

Jackie Doyle-Price

Parliamentary Under Secretary of State,

Department of Health

29th June 2017

Richard Pengelly

A senior official of the Department of Health in Northern Ireland

29th June 2017

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”).

Regulation 8 amends Schedule 17 of the 2012 Regulations so that auto-injectors containing adrenaline can be administered in schools in an emergency to pupils who are known to require such medication. It also corrects an omission in the provisions allowing orthoptists to sell or supply certain prescription only medicines by requiring that there is an annotation against their names in the relevant register signifying that they are qualified to sell or supply the medicines.

Regulations 3-6 make minor drafting amendments to the 2012 Regulations to increase the clarity of certain provisions.

Regulation 7 amends regulation 346 of the 2012 Regulations to provide that the new provisions relating to auto-injectors containing adrenaline are subject to review by the Secretary of State.

A full impact assessment has not been produced for this instrument as no adverse impact on private, public or voluntary sectors is foreseen.

(1)

The Department of Health, Social Services and Public Safety was renamed the Department of Health by s. 1(5) of the Departments Act (Northern Ireland) 2016 (c.5) (N.I.).

(2)

1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7). Section 2(5) was amended by section 41(1) of and Part 1 of Schedule 6 to the Northern Ireland Constitution Act 1973 (c.36).

(3)

See S.I. 1972/1811 which designates the Secretary of State and any department of the Government of Northern Ireland for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products.

(5)

Regulation 8 has been previously amended by S.I. 2013/1855 and 2593, 2015/354 and 2016/186, 190 and 696.

(6)

Regulation 45B was inserted by S.I. 2013/1855.

(7)

Regulation 213 was amended by and S.I. 2013/235, 2014/490 and 1878, 2015/323 and 2016/186.

(8)

Regulation 346 was substituted by S.I. 2013/1855 and then amended by S.I. 2013/2593, 2014/490 and 1878 and 2015/323, 903 and 1503 and 2016/186.

(9)

Part 1 was amended by S.I. 2014/1878 and 2016/186.

(10)

Part 3 was amended by S.I. 2014/490.

(11)

Part 4 was amended by S.I. 2013/2593 and 2016/186.