Paragraph 108 I1

After regulation 139 (amendment of regulation 177 (application of part and interpretation)) insert—

“Amendment of regulation 179 (obligation on licensing authority to operate pharmacovigilance system)

139A

In regulation 179—

(a)

in paragraph (1), after “pharmacovigilance system” insert “ in relation to medicinal products for sale or supply in Great Britain ”;

(b)

after paragraph (1) insert—

“(1A)

The licensing authority must operate a pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland.”;

(c)

in paragraph (2) for “The pharmacovigilance system” substitute “ Each pharmacovigilance system ”; and

(d)

in paragraph (3)(a) for “the pharmacovigilance system” substitute “ each pharmacovigilance system ”.”.