PART 1General

Classification of medicinal products5

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).