Regulation 146 Insertion of new regulation 187A (collaboration with the World Health Organisation)I1

After regulation 186 insert—

“

186A

The licensing authority must collaborate with the World Health Organisation in matters of pharmacovigilance, and must in particular—

(a)

take the necessary steps to promptly submit to the World Health Organisation appropriate and adequate information regarding the measures taken in the United Kingdom which may have a bearing on public health protection in other countries; and

(b)

make available promptly all suspected adverse reaction reports occurring in the United Kingdom to the World Health Organisation.”.