Search Legislation

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

What Version

 Help about what version
  • Latest available (Revised)
  • Original (As made)

Opening Options

 Help about opening options

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

Statutory Instruments

2015 No. 1503

Medicines

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

Made

9th July 2015

Laid before Parliament

16th July 2015

Coming into force

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 1972(1), having been designated for the purposes of section 2(2) of that Act in relation to medicinal products(2).

Citation and commencement

1.  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 2012

2.  The Human Medicines Regulations 2012(3) are amended as follows.

Amendment of regulation 8

3.—(1) Regulation 8(4) (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 38

4.  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 39

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

Amendment of regulation 44

6.—(1) Regulation 44(6) (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 233

7.—(1) Regulation 233(7) (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 256E

8.  In regulation 256E(8) (removal of a person’s entry from the list), in paragraph (a), for “256I(1)(b)” substitute “256I(1)(c)”.

Amendment of regulation 346

9.—(1) Regulation 346(9) (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)(10) insert—

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

(b)in sub-paragraph (d), for paragraph (iva)(11) 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,.

Amendment of Schedule 17

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

(2) In Part 2(12) (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 5(13) (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.

Jane Ellison

Parliamentary Under-Secretary of State,

Department of Health

9th July 2015

Simon Hamilton

Minister for 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.

(1)

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).

(2)

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

(3)

S.I. 2012/1916 as amended by S.I. 2013/235, 1855 and 2593, 2014/490 and 1878 and 2015/323 and 903.

(4)

Regulation 8 was amended by S.I. 2013/1855 and 2593.

(5)

Regulation 39 was amended by S.I. 2013/1855.

(6)

Regulation 44 was substituted by S.I. 2013/1855.

(7)

Regulation 233 was amended by S.I. 2013/235

(8)

Regulation 256E was inserted by S.I. 2013/1855.

(9)

Regulation 346 was substituted by S.I. 2013/1855.

(10)

Paragraph (xxviiif) was inserted by S.I. 2015/323.

(11)

Paragraph (iva) was substituted by S.I. 2014/1878.

(12)

Part 2 was amended by S.I. 2014/1878.

(13)

Part 5 was amended by S.I. 2014/1878.

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made):The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

Explanatory Memorandum

Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Impact Assessments

Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:

  • Why the government is proposing to intervene;
  • The main options the government is considering, and which one is preferred;
  • How and to what extent new policies may impact on them; and,
  • The estimated costs and benefits of proposed measures.
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources