Regulation 10 Duties of the Authority

After section 8 (general functions of the Authority), insert—

“8A.

Duty of Authority to communicate with competent authorities of other EEA states

The Authority shall communicate to the competent authorities of EEA states other than the United Kingdom or of Gibraltar, and to the European Commission, such information in relation to serious adverse events and serious adverse reactions as is necessary for the purpose of enabling appropriate action to be taken, including where necessary the withdrawal from use of gametes and embryos that are intended for human application but are known or suspected to be unsuitable for such application.”.