Licence conditions
F115ADuties of the Authority in relation to serious adverse events and serious adverse reactions
1
The Authority shall investigate serious adverse events and serious adverse reactions and take appropriate control measures.
2
In investigating any serious adverse event or serious adverse reaction, the Authority shall, where it is appropriate to do so, arrange for—
a
any premises to which a licence relates and any relevant third party premises to be inspected on its behalf, and
b
a report on the inspection to be made to it.
3
F2If the Authority, in relation to Northern Ireland, receives a request from a competent authority in an EEA state to carry out an inspection in relation to a serious adverse event or serious adverse reaction, the Authority must arrange for such an inspection to be carried out, for a report to be made of the inspection and for appropriate control measures to be taken.