The Human Medicines (Amendment) Regulations 2016

• Citation: S.I. 2016/186
• Sections: 17

Section 1 Citation and commencement

These Regulations may be cited as the Human Medicines (Amendment) Regulations 2016 and shall come into force on 1st April 2016.

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 “suspected” insert—

“therapeutic radiographer independent prescriber” means a person—

who is a registered radiographer; and

against whose name is recorded in the relevant register—

an entitlement to use the title “therapeutic radiographer”; and

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;

Section 4 Amendment of regulation 18 (wholesale dealing in medicinal products)

In regulation 18 , in paragraph (6) omit sub-paragraph (a).

Section 5 Amendment of regulation 20 (mixing of medicines)

(1) Regulation 20 is amended as follows.

(2) In paragraph (1)—

(a) after sub-paragraph (cb) insert—

(cc) a therapeutic radiographer independent prescriber;

(b) in sub-paragraph (d)—

(i) in paragraph (v) omit “or”; and

(ii) after paragraph (vi) insert—

(vii) therapeutic radiographer independent prescriber; or

Section 6 Amendment of regulation 43 (obligations of licence holder)

(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.

Section 7 Amendment of regulation 44 (requirement for wholesale dealers to deal only with specified persons)

In regulation 44 , in paragraph (6) omit “(4)(c),”.

Section 8 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”, 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;

Section 9 Amendment of regulation 214 (sale or supply of prescription only medicines)

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.

Section 10 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 (viii) omit “or”; and

(b) after paragraph (ix) insert—

or

(x) a therapeutic radiographer independent prescriber.

Section 11 Amendment of regulation 229 (exemption for supply by national health service bodies and local authorities)

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

Section 12 Amendment of regulation 248 (exemption for certain collection and delivery arrangements)

(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”.

Section 13 Amendment of regulation 256A (interpretation of Part 12A)

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).

Section 14 Amendment of regulation 256B (person who may sell medicinal products by information society services)

In regulation 256B , in paragraph (8)(b), for “the notification from that person” substitute “that person’s entry on the list”.

Section 15 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 (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

Section 16 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 1 (exemption from restrictions on sale and supply of prescription only medicines), after item 12 in the table insert—

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.

(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 Prescription only medicines for parenteral administration that contain–

(a) Diamorphine,

(b) Morphine,

(c) Pethidine hydrochloride.

(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 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.

Section 17 Amendment of Schedule 23 (particulars in pharmacy records)

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