Regulation 139A Amendment of regulation 179 (obligation on licensing authority to operate pharmacovigilance system)F1I1

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

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.”;

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

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