
1 
These Regulations may be cited as the Human Medicines (Amendment) Regulations 2016 and shall come into force on 1st April 2016.
2 
The Human Medicines Regulations 2012 are amended as follows.
3 

(1) Regulation 8 is amended as follows.
(2) In paragraph (1)—
(a) after the definition of “suspected” insert—“
 “therapeutic radiographer independent prescriber” means a person—
(a) who is a registered radiographer; and
(b) against whose name is recorded in the relevant register—
(i) an entitlement to use the title “therapeutic radiographer”; and
(ii) an annotation signifying that the person is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;”;
(b) after the definition of “radiopharmaceutical” insert—“
 “registered dietitian” means a person registered in Part 4 of the Health and Care Professions Council register;”;
(c) after the definition of “registered pharmacy” insert—“
 “registered physiotherapist” means a person registered in Part 9 of the Health and Care Professions Council register;
 “registered podiatrist” means a person registered in Part 2 of the Health and Care Professions Council register;
 “registered radiographer” means a person registered in Part 11 of the Health and Care Professions Council register;”;
(d) in the definition of “supplementary prescriber”—
(i) in paragraph (d) omit “or”; and
(ii) after paragraph (e) insert—“or
(f) a registered dietitian;”;
4 
In regulation 18 in paragraph (6) omit sub-paragraph (a).
5 

(1) Regulation 20 is amended as follows.
(2) In paragraph (1)—
(a) after sub-paragraph cb) insert—“(cc) a therapeutic radiographer independent prescriber;”; and
(b) in sub-paragraph (d)—
(i) in paragraph (v) omit “or”; and
(ii) after paragraph (vi) insert—“
(vii) therapeutic radiographer independent prescriber; or”.
6 

(1) Regulation 43 is amended as follows
(2) In paragraph (6)—
(a) in sub-paragraph (b) omit “or”; and
(b) after sub-paragraph (c) insert—“
 or
(d) the wholesale distribution of medicinal products to a person in a third country.”.
7 
In regulation 44, in paragraph (6) omit “(4)(c),”.
8 

(1) Regulation 213 is amended as follows.
(2) In paragraph (1)—
(a) in the definition of “health prescription”, for “pharmacist — independent prescriber” substitute “pharmacist independent prescriber, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber”;
(b) omit the definition of “registered dietitian”;
(c) omit the definition of “registered physiotherapist”;
(d) omit the definition of “registered podiatrist”;
(e) omit the definition of “registered radiographer”; and
(f) in the definition of “relevant prescriber”, after paragraph (f) insert—“(fa) a physiotherapist independent prescriber;(fb) a podiatrist independent prescriber;(fc) a therapeutic radiographer independent prescriber;”.
9 
In regulation 214, after paragraph (5B) insert—“
(5C) A therapeutic radiographer 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;
(d) Morphine;
(e) Oxycodone;
(f) Temazepam; or
(g) Tramadol.”
10 

(1) Regulation 223 is amended as follows.
(2) In paragraph (3)(b)—
(a) in paragraph (viii) omit “or”; and
(b) after paragraph (ix) insert—“or
(x) a therapeutic radiographer independent prescriber.”.
11 
In regulation 229, in paragraph (2), after “optometrist independent prescriber” insert “, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber”.
12 

(1) Regulation 248 is amended as follows.
(2) In paragraph (1)(a), after “pharmacist independent prescriber” insert “, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber”.
(3) In paragraph (2)(a), after “pharmacist independent prescriber” insert “, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber”.
13 
In regulation 256A—
(a) the existing text becomes paragraph (1); and
(b) after that paragraph insert—“
(2) In this Part, references to selling a medicinal product at a distance to the public by means of information society services, however expressed, include supplying and offering to sell or supply a medicinal product at a distance to the public by means of information society services (and related expressions are to be interpreted accordingly).”.
14 
In regulation 256B, in paragraph (8)(b), for “the notification from that person” substitute “that person’s entry on the list”.
15 

(1) Regulation 346 is amended as follows.
(2) In paragraph (2)—
(a) in sub-paragraph (c)—
(i) in paragraph (i) for “18(6)(a)” substitute “18(6)”;
(ii) in paragraph (iv) after “(6)(a)” insert “and (d)”;
(iii) after paragraph (xxviiib) insert—“
(xxviiiba) 214(5C),”;
(iv) after paragraph (xxviiie) insert—“
(xxviiiea) 223(3)(b),”;
(v) in paragraph (xxviiif) after “and (dc)” insert “and (2)”;
(vi) after paragraph (xxviiig) insert—“
(xxviiih) 248(1)(a) and (2)(a),”;
(b) in sub-paragraph (d)—
(i) for paragraph (iva) substitute—“
(iva) 17, Part 1 items 12 and 13, Part 2 items 4a, 11 and 12, Part 4 items 11 to 13 and Part 5 items 7a and 18,
(ivaa) 23, paragraph 1(a)(vii) to (ix), and”.
16 

(1) Schedule 17 is amended as follows.
(2) In the table in Part 1 (exemption from restrictions on sale and supply of prescription only medicines), after item 12 in the table insert—“
13 Registered orthoptists. 13 The following prescription only medicines-(a) Atropine,(b) Cyclopentolate,(c) Tropicamide,(d) Lidocaine with fluorescein,(e) Oxybuprocaine,(f) Proxymetacaine,(g) Tetracaine,(h) Chloramphenicol,(i) Fusidic acid. 13 The sale or supply shall be only in the course of their professional practice.”
(3) In the table in Part 2 (exemption from the restriction on supply of prescription only medicines), after item 11 in the table insert—“
12 Registered midwives. 12 Prescription only medicines for parenteral administration that contain-(a) Diamorphine,(b) Morphine,(c) Pethidine hydrochloride. 12 The supply shall be only in the course of their professional practice.”
(4) In the table in Part 4 (exemption for certain persons who sell or supply certain medicinal products), after item 12 in the table insert—“
13 Registered orthoptists 13 All medicinal products on a general sale list, all pharmacy medicines and the following prescription only medicines-(a) Atropine,(b) Cyclopentolate,(c) Tropicamide,(d) Lidocaine with fluorescein,(e) Oxybuprocaine,(f) Proxymetacaine,(g) Tetracaine,(h) Chloramphenicol,(i) Fusidic acid. 13 The sale or supply shall be only in the course of their professional practice.”
17 
In Schedule 23, for paragraphs 1(a)(v) and (vi) substitute—“
(v) an optometrist independent prescriber,
(vi) a pharmacist independent prescriber,
(vii) a podiatrist independent prescriber,
(viii) a physiotherapist independent prescriber, or
(ix) a therapeutic radiographer independent prescriber, or”.
Signed by the authority of the Secretary of State
George Freeman
Parliamentary Under Secretary of State
Department of Health
8th February 2016
Simon Hamilton
Minister for Health, Social Services and Public Safety
16th February 2016