SCHEDULES

F1SCHEDULE 3ASUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION

Serious adverse events and serious adverse reactions F2: Great Britain

3

F3In relation to Great Britain, licence conditions shall require such—

(a)

systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and

(b)

accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,

to be in place as F4the Authority considers appropriate.