215

In regulation 295—

a

for paragraph (2)(d) substitute—

d

the name and address of the holder—

i

in the case of a medicinal product for sale or supply in Great Britain, of the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK) for the medicinal product, or

ii

in the case of a medicinal product for sale or supply in Northern Ireland, the name and address of the holder of the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation, or Article 126a authorisation for the medicinal product,

or the business name and address of the part of the holder’s business that is responsible for the sale or supply of the medicinal product.

b

after paragraph (4) insert—

4A

In the application of this regulation to a medicinal product for sale or supply—

a

in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland,

b

in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and

c

in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both—

i

the product for sale or supply in Great Britain, and

ii

the product for sale or supply in Northern Ireland.