- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
Statutory Instruments
Medicines
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).
1. These Regulations may be cited as the Human Medicines (Amendment) (No. 3) Regulations 2015 and shall come into force on 1st October 2015.
2. The Human Medicines Regulations 2012(3) are amended as follows.
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)”.
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”.
5. In regulation 39(5) (further requirements for manufacturer’s licence), in paragraph (8), for “44(4) to (6)” substitute “44(5) and (6)”.
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”.
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”.
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)”.
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,”.
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
(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.
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).
See S.I. 1972/1811 regarding the designation of Ministers.
S.I. 2012/1916 as amended by S.I. 2013/235, 1855 and 2593, 2014/490 and 1878 and 2015/323 and 903.
Regulation 8 was amended by S.I. 2013/1855 and 2593.
Regulation 39 was amended by S.I. 2013/1855.
Regulation 44 was substituted by S.I. 2013/1855.
Regulation 233 was amended by S.I. 2013/235
Regulation 256E was inserted by S.I. 2013/1855.
Regulation 346 was substituted by S.I. 2013/1855.
Paragraph (xxviiif) was inserted by S.I. 2015/323.
Paragraph (iva) was substituted by S.I. 2014/1878.
Part 2 was amended by S.I. 2014/1878.
Part 5 was amended by S.I. 2014/1878.
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.
Mae Memoranda Esboniadol yn nodi datganiad byr o ddiben Offeryn Statudol ac yn rhoi gwybodaeth am ei amcan polisi a goblygiadau polisi. Maent yn ceisio gwneud yr Offeryn Statudol yn hygyrch i ddarllenwyr nad oes ganddynt gymhwyster cyfreithiol, ac maent yn cyd-fynd ag unrhyw Offeryn Statudol neu Offeryn Statudol Drafft a gyflwynwyd ger bron y Senedd o Fehefin 2004 ymlaen.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
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:
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys