Regulation 218 Requirements for prescriptions: approved country health professionalF9

United Kingdom

(1)

For the purposes of this Chapter, a prescription only medicine is not sold or supplied in accordance with a prescription given by an appropriate practitioner who is an F1approved country health professional unless the following conditions are met.

F2(2)

Condition A is that—

(a)

the prescription is issued in a F3country included in the list published under regulation 214(6A); and

(b)

the prescribing approved country health professional is legally entitled to issue a prescription of that kind in the country in which the prescription is issued.

F4(3)

Condition B is that the prescription is signed in ink by the prescribing approved country health professional.

(4)

Condition C is that the prescription is written in ink or otherwise so as to be indelible.

F5(5)

Condition D is that the prescription contains—

(a)

the patient’s—

(i)

surname,

(ii)

first names written out in full, and

(iii)

date of birth;

(b)

the issue date of the prescription;

(c)

the prescribing F6approved country health professional's—

(i)

surname,

(ii)

first names written out in full,

(iii)

professional qualification,

(iv)

direct contact details including—

(aa)

email address, and

(bb)

telephone or fax number with the appropriate international prefix,

(v)

work address, and

(vi)

name of the relevant member State in which that approved country health professional works; and

(d)

details about the prescribed product, including where applicable the—

(i)

common name of the product,

(ii)

brand name if—

(aa)

the prescribed product is a biological medicinal product, or

(bb)

the prescribing approved country health professional deems it medically necessary for that product to be dispensed and the F7approved country health professional's reasons justifying the use of the branded product,

(iii)

pharmaceutical formulation (tablet, solution, etc.),

(iv)

quantity,

(v)

strength of the medicinal product as defined in Article 1 of the 2001 Directive, and

(vi)

dosage regimen.

(6)

Condition E is that the prescription—

(a)

is not dispensed after the end of the period of six months beginning with the date on which it is signed by the approved country health professional; or

(b)

in the case of a repeatable prescription—

(i)

it is not dispensed for the first time after the end of that period, and

(ii)

it is dispensed in accordance with the directions contained in the prescription.

(7)

Condition F is that, in the case of a repeatable prescription that does not specify the number of times it may be dispensed—

(a)

it is not dispensed on more than two occasions; or

(b)

in the case of a prescription for an oral contraceptive, it is not dispensed on more than six occasions or after the end of the period of six months beginning with the date on which it is signed by the approved country health professional.

(8)

This regulation is subject to regulation F8219A (electronic prescriptions: EEA health professionals).

Annotations

Textual amendments

F1: Words in reg. 218 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(2); 2020 c. 1, Sch. 5 para. 1(1)
F2: Reg. 218(2) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 23 and reg. 218(2) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 23
F3: Words in reg. 218(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(4); 2020 c. 1, Sch. 5 para. 1(1)
F4: Reg. 218(3) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 7(3) and reg. 218(3) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 7(3)
F5: Reg. 218(5) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 7(4) and reg. 218(5) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 7(4)
F6: Words in reg. 218(5)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(3); 2020 c. 1, Sch. 5 para. 1(1)
F7: Words in reg. 218(5)(d)(ii)(bb) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(3); 2020 c. 1, Sch. 5 para. 1(1)
F8: Words in reg. 218(8) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 3 and words in reg. 218(8) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 3
F9: Words in reg. 218 heading substituted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(2); 2020 c. 1, Sch. 5 para. 1(1)

Notes on Part 12

Modifications

C1: Pt. 12 modified (E.W.) (1.10.2015) by The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 (S.I. 2015/895), regs. 1(3), 4(2)