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

S.R. 2015/354 · Made 9 July 2015

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Medicines

Made 9th July 2015

Laid before Parliament 16th July 2015

Coming into operation 1st October 2015

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 1972f1, having been designated for the purposes of section 2(2) of that Act in relation to medicinal productsf2.

Annotations to the whole text

Footnotes

f1

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).

f2

See S.I.1972/1811 regarding the designation of Ministers.

Contents

  1. 1Citation and commencement
  2. 2Amendment of the Human Medicines Regulations 2012
  3. 3Amendment of regulation 8
  4. 4Amendment of regulation 38
  5. 5Amendment of regulation 39
  6. 6Amendment of regulation 44
  7. 7Amendment of regulation 233
  8. 8Amendment of regulation 256E
  9. 9Amendment of regulation 346
  10. 10Amendment of Schedule 17
  11. Signature
  12. Explanatory note

1Citation 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.

2Amendment of the Human Medicines Regulations 2012

The Human Medicines Regulations 2012f1 are amended as follows.

3Amendment of regulation 8

(1)

Regulation 8f1 (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)”.

4Amendment 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”.

5Amendment of regulation 39

In regulation 39f1 (further requirements for manufacturer’s licence), in paragraph (8), for “44(4) to (6)” substitute “44(5) and (6)”.

6Amendment of regulation 44

(1)

Regulation 44f1 (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”.

7Amendment of regulation 233

(1)

Regulation 233f1 (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”.

8Amendment of regulation 256E

In regulation 256Ef1 (removal of a person’s entry from the list), in paragraph (a), for “256I(1)(b)” substitute “256I(1)(c)”.

9Amendment of regulation 346

(1)

Regulation 346f1 (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)f2 insert—

“(xxviiifa)

233(1)(a)(ivd) and (ive),”;and

(b)

in sub-paragraph (d), for paragraph (iva)(g) 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,”.

10Amendment of Schedule 17

(1)

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

(2)

In Part 2f1 (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 parental administration containing naloxone hydrochloride but no other substance that is classified as a product available on prescription only.4a The supply shall be onl 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 5f2 (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 the 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

7a A prescription only medicine for parental 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.

”

Signature

Signed by the authority of the Secretary of State.

Jane Ellison

Parliamentary Under-Secretary of State,

Department of Health

9th July 2015

Simon Hamilton

Minister,

Department of Health, Social Services and Public Safety

9th July 2015

Explanatory note

(This note is not part of the Regulations)

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

Regulation 7 amends regulation 233 of the 2012 Regulations to enable Public Health England and the Regional Agency for Public Health and Social Well-being in Northern Ireland to enter into arrangements with retail pharmacists to supply prescription only medicines under a patient group direction (PGD). A PGD is a written instruction for the supply or administration of medicines to patients in defined clinical situations without the need for a prescription.

Regulation 10 amends Schedule 17 to the 2012 Regulations to enable the prescription only medicine naloxone hydrochloride to be supplied by drug treatment services for the purpose of saving life in an emergency.

Regulation 9 amends the 2012 Regulations so that the new provisions relating to patient group directions and to drug treatment services are subject to review by the Secretary of State.

Additionally, regulations 3 to 6 and 8 make minor corrections, including updating cross-references and removing obsolete provisions in the 2012 Regulations.

A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.

Amendments to the Human Medicines Regulations 2012 are subject to the requirements of the Statutory Rules (NI) Order 1979 and the corresponding SI in respect of this Statutory Rule is S.I.1503/2015.