Regulation 40 Amendment of regulation 45E (criteria of broker's registration)I1

for sub-paragraph (b)(i) substitute—

“(i)

ordered by—

(aa)

in the case of a broker in Great Britain, the licensing authority or by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(bb)

in the case of a broker in Northern Ireland, the licensing authority or by the competent authority of any EEA State, or”;

in sub-paragraph (d)(iii), before “the batch number” insert “where the sale or supply of the medicinal product is in Northern Ireland,”.