—

i

in relation to Great Britain, in one or more establishments authorised under regulation 4, or in a country where the safety and quality standards for establishments authorised in that country are equivalent to those for establishments authorised under regulation 4, to undertake activities relating to the collection or testing (or both) of blood and blood components, or to their preparation, storage or distribution;

ii

in relation to Northern Ireland, in one or more establishments authorised in a member State, or under regulation 4, to undertake such activities.