# The Human Medicines Regulations 2012, 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 sale.
(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) in 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;
(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) ....
(4) In paragraph (3)(a) “authorisation” means—
(a) a UK marketing authorisation; or
(b) in the case of a medicinal product for sale or supply in Northern Ireland (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;
(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) ....

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/5 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.