Citation and commencement

1.  These Regulations may be cited as the Human Medicines (Amendment) Regulations 2018 and shall come into force on 1st April 2018.

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)after the definition of "the Paediatric Regulation" insert-

""paramedic independent prescriber" means a person-

(b)after the definition of "qualified person" insert-

""radiation emergency" has the meaning given by regulation 2(1) of the Radiation (Emergency Preparedness and Public Information) Regulations 2001(6);";

(c)after the definition of "registered optometrist" insert-

""registered paramedic" means a person who is registered in Part 8 of the Health and Care Professions Council register;";

(d)in the definition of "the relevant register", in paragraph (d)-

(i)after "an orthoptist" insert ", a paramedic";

(ii)in sub-paragraph (iii) omit "or"; and

(iii)after sub-paragraph (iv)-

", or

(v)paramedics;"; and

(e)in the definition of "supplementary prescriber", in paragraph (d) after "physiotherapist" insert ", paramedic".

Amendment of regulation 20 (mixing of medicines)

4.-(1) Regulation 20(7) is amended as follows.

(2) In paragraph (1)-

(a)after sub-paragraph (cc), insert-

"(cd)a paramedic independent prescriber;"; and

(b)in sub-paragraph (d), after paragraph (vii) insert-

"(viii)paramedic independent prescriber; or".

Amendment of regulation 213 (interpretation of Part 12)

5.-(1) Regulation 213(8) is amended as follows.

(2) In paragraph (1)-

(a)in the definition of "health prescription", after "therapeutic radiographer independent prescriber" insert ", paramedic independent prescriber";

(b)omit the definition of "registered paramedic"; and

(c)in the definition of "relevant prescriber", after paragraph (fc) insert-

"(fd)a paramedic independent prescriber;".

Amendment of regulation 214 (sale or supply of prescription only medicines)

6.  In regulation 214(9), after paragraph (5C), insert-

"(5D) A paramedic independent prescriber is an appropriate practitioner in relation to any prescription only medicine unless that medicinal product contains a product subject to special medical prescription other than-

(a)Codeine;

(b)Fentanyl;

(c)Midazolam; or

(d)Morphine.".

Amendment of regulation 223 (exemptions for doctors and dentists etc)

7.-(1) Regulation 223(10) is amended as follows.

(2) In paragraph (3)(b)-

(a)in paragraph (ix) omit "or"; and

(b)after paragraph (x) insert-

", or

(xi)a paramedic independent prescriber.".

Amendment of regulation 228 (exemptions relating to prescriptions given by certain health professionals)

8.-(1) Regulation 228 is amended as follows.

(2) In paragraph (2)(d)-

(a)in paragraph (ii) omit "or"; and

(b)after paragraph (iii) insert-

"(iv)paramedics; or".

Amendment of regulation 229 (exemption for supply by national health service bodies and local authorities)

9.  In regulation 229(11), in paragraph (2), after "therapeutic radiographer independent prescriber" insert ", paramedic independent prescriber".

Amendment of regulation 248 (exemption for certain collection and delivery arrangements)

10.-(1) Regulation 248(12) is amended as follows.

(2) In paragraph (1)(a), after "therapeutic radiographer independent prescriber" insert ", paramedic independent prescriber".

(3) In paragraph (2)(a), after "therapeutic radiographer independent prescriber" insert ", paramedic independent prescriber".

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

11.-(1) Regulation 346(13) is amended as follows-

(2) In paragraph (2)-

(a)in sub-paragraph (c)-

(i)in paragraph (xxviiiba), after "214(5C)" insert "and (5D)"; and

(ii)after paragraph (xxviiiea) insert-

"(xxviiieb)228(2)(d)(iv),"; and

(b)in sub-paragraph (d)-

(i)in paragraph (iva), after "and 18" insert to "to 20"; and

(ii)in paragraph (ivaa), for "(ix)" substitute "(x)".

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

12.-(1) Schedule 17 is amended as follows.

(2) In the table in Part 5(14) (exemptions from the restrictions in regulation 220 and 221 for certain persons who supply certain medicinal products), after item 18 in the table insert-

Amendment of Schedule 23 (particulars in pharmacy records)

13.-(1) Schedule 23(17) is amended as follows.

(2) In paragraph 1(a)-

(a)in paragraph (viii) omit "or"; and

(b)after paragraph (ix) insert-

"(x)a paramedic independent prescriber; or".

EXPLANATORY NOTE

(This note is not part of the Regulations)

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

Regulation 3 updates the general interpretation provisions in the 2012 Regulations to insert new definitions of radiation emergency and paramedic independent prescriber and to add paramedics to the list of health professionals who are included in the definition of a supplementary prescriber.

Regulations 4 to 10 and 13 are required to enable paramedic independent prescribers to mix, prescribe, sell or supply certain type of prescription only medicines.

Regulation 11 amends the 2012 Regulations to ensure that the new provisions are subject to review by the Secretary of State.

Regulation 12 amends Schedule 17 to the 2012 Regulations so that pharmacy medicines containing Potassium Iodide or Potassium Iodate can be supplied in the event of a radiation emergency by persons acting in accordance with an off-site emergency plan or by persons listed in Part 1 or 2 of Schedule 1 to the Civil Contingencies act 2004.

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. 199/2018.

An assessment of the impact of S.I. 199/2018 on the private and public sector has been prepared in relation to the amendments for paramedic independent prescribers. A copy of that impact assessment is published with the Explanatory Memorandum alongside the instrument on www.legislation.co.uk. Copies may also be obtained from the Department of Health and Social Care, 2E14 Quarry House, Leeds, LS2 7UE. A full impact assessment has not been produced for the amendments relating to Potassium Iodide and Potassium Iodate as no, or no significant, impact on the private, voluntary or public sectors is foreseen. However, an impact statement has been prepared and is available on request from the Department for Business, Energy and Industrial Strategy, 1 Victoria Street, London, SW1H 0ET.