Section 15A Duties of the Authority in relation to serious adverse events and serious adverse reactionsF1
United Kingdom
The Authority shall investigate serious adverse events and serious adverse reactions and take appropriate control measures.
In investigating any serious adverse event or serious adverse reaction, the Authority shall, where it is appropriate to do so, arrange for—
any premises to which a licence relates and any relevant third party premises to be inspected on its behalf, and
a report on the inspection to be made to it.
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.
Annotations
Textual amendments
- F1
S. 15A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 18
- F2
Words in s. 15A(3) substituted (31.12.2020) by S.I. 2019/482, reg. 2(9) (as substituted by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 10); 2020 c. 1, Sch. 5 para. 1(1)