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The Human Medicines Regulations 2012

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Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).

Classification of medicinal products

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5.—(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; or

(b)a product that—

(i)is covered by an EU marketing authorisation, and

(ii)is not classified in the authorisation as a prescription only medicine, and

(iii)the licensing authority has determined should be available on general sale.

(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)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)a medicinal product that—

(i)is covered by an EU marketing authorisation, and

(ii)is classified in the authorisation as a prescription only medicine;

(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) or (b).

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

(a)a UK marketing authorisation; or

(b)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)a product that—

(i)is covered by an EU marketing authorisation, and

(ii)is not classified in the authorisation as a prescription only medicine,

other than a product to which paragraph (1)(b)(iii) applies;

(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) or (b).

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