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The Human Medicines Regulations 2012
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- UK Statutory Instruments
- 2012 No. 1916
- PART 1
- Regulation 5
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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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