The Human Medicines (Amendment) Regulations 2018

• Citation: S.I. 2018/199
• Sections: 13

Section 1 Citation and commencement

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

Section 2 Amendment of the Human Medicines Regulations 2012

The Human Medicines Regulations 2012 are amended as follows.

Section 3 Amendment of regulation 8 (general interpretation)

(1) Regulation 8 is amended as follows.

(2) In paragraph (1)—

(a) after the definition of “the Paediatric Regulation” insert—

“paramedic independent prescriber” means a person—

who is a registered paramedic; and

against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a paramedic independent prescriber;

(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 ;

(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) insert—

, or

(v) paramedics;

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

Section 4 Amendment of regulation 20 (mixing of medicines)

(1) Regulation 20 is amended as follows.

(2) In paragraph (1)—

(a) after sub-paragraph (cc), insert—

(cd) a paramedic independent prescriber;

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

(viii) paramedic independent prescriber; or

Section 5 Amendment of regulation 213 (interpretation of Part 12)

(1) Regulation 213 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;

Section 6 Amendment of regulation 214 (sale or supply of prescription only medicines)

In regulation 214 , 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.

Section 7 Amendment of regulation 223 (exemptions for doctors and dentists etc)

(1) Regulation 223 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.

Section 8 Amendment of regulation 228 (exemptions relating to prescriptions given by certain health professionals)

(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

Section 9 Amendment of regulation 229 (exemption for supply by national health service bodies and local authorities)

In regulation 229 , in paragraph (2), after “therapeutic radiographer independent prescriber” insert “, paramedic independent prescriber”.

Section 10 Amendment of regulation 248 (exemption for certain collection and delivery arrangements)

(1) Regulation 248 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”.

Section 11 Amendment of regulation 346 (Secretary of State to carry out a review of certain provisions)

(1) Regulation 346 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),

(b) in sub-paragraph (d)—

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

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

Section 12 Amendment of Schedule 17 (exemption for sale, supply or administration by certain persons)

(1) Schedule 17 is amended as follows.

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

19 Pharmacy medicines which contain any of the following substances but no other active ingredient—

(a) Potassium Iodide;

(b) Potassium Iodate.

19 The supply shall be—

(a) in accordance with the off-site emergency plan; and

(b) only in the event that a radiation emergency has occurred or an event has occurred which could reasonably be expected to lead to a radiation emergency.

20 Pharmacy medicines which contain any of the following substances but no other active ingredient—

(a) Potassium Iodide;

(b) Potassium Iodate.

20 The supply shall only be in response to the occurrence, or likely occurrence, of one of the following events—

(a) an emergency within the meaning of section 1 of the Civil Contingencies Act 2004;

(b) a radiological emergency within the meaning of regulation 24 of the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 .

Section 13 Amendment of Schedule 23 (particulars in pharmacy records)

(1) Schedule 23 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