Regulation 5 Classification of medicinal products

(1)

In these Regulations references to a medicinal product subject to general sale are to a product that is not a prescription only medicine or a pharmacy medicine but is—

(a)

a product that is covered by an authorisation of which it is a term that the product is to be available on general saleF1.

F2(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2)

In paragraphs (1)(a) and (5)(a) “authorisation” means—

(a)

a UK marketing authorisation;

(b)

a certificate of registration;

(c)

a traditional herbal registration; or

(d)

F3in the case of a medicinal product for sale or supply in Northern Ireland, an Article 126a authorisation.

(3)

In these Regulations references to a prescription only medicine are to any of the following—

(a)

a medicinal product that is covered by an authorisation of which it is a term that the product is to be available only on prescription;

F4(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)

a medicinal product that is a prescription only medicine by virtue of Part 1 of Schedule 1; or

(d)

a medicinal product that is the result of—

(i)

the assembly, or

(ii)

the reformulation (including the combining with other substances),

of a medicinal product that is a prescription only medicine by virtue of sub-paragraph (a) F5....

(4)

In paragraph (3)(a) “authorisation” means—

(a)

a UK marketing authorisation; or

(b)

F6in the case of a medicinal product for sale or supply in Northern Ireland F7(that is not a listed NIMAR product), an Article 126a authorisation.

(5)

In these Regulations references to a pharmacy medicine are to a medicinal product that is not a prescription only medicinal product or a medicinal product subject to general sale but is—

(a)

covered by an authorisation of which it is a term that the product is to be available only from a pharmacy;

F8(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)

available only from a pharmacy by virtue of Part 2 of Schedule 1; or

(d)

the result of—

(i)

the assembly, or

(ii)

the reformulation (including the combining with other substances),

of a medicinal product that is a pharmacy medicine by virtue of sub-paragraph (a) F9....

Annotations

Textual amendments

F1: Reg. 5(1)(a): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(a)(i)
F2: Reg. 5(1)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(a)(ii)
F3: Words in reg. 5(2)(d) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 7(3)(b) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(b)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
F4: Reg. 5(3)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(b)(i)
F5: Words in reg. 5(3)(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(b)(ii)
F6: Words in reg. 5(4)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 7(5) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(d)); 2020 c. 1, Sch. 5 para. 1(1)
F7: Words in reg. 5(4)(b) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 3
F8: Reg. 5(5)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(c)(i)
F9: Words in reg. 5(5)(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(c)(ii)