[F13.U.K.The following requirements must be specified in directions under section 24(4) authorising any person to whom a licence applies to make any qualifying imports—
(a)a requirement that the person must not make any substantial changes in connection with any qualifying imports made by the person unless the Authority approves those changes in writing,
(b)a requirement that the person must notify the Authority if the person ceases to make qualifying imports,
(c)a requirement that the person must—
(i)notify the Authority of any serious adverse events or serious adverse reactions notified to the person by the person’s third country supplier (including events or reactions which that supplier suspects are serious adverse events or reactions), and
(ii)provide any information specified in the direction which the Authority requires for the purposes of securing compliance with the requirements of Article 6(2) of the fourth Directive (updated information), and
(d)a requirement that the person must notify the Authority of any changes in circumstances of the person’s third country supplier of which the person is aware.]
Textual Amendments
F1Sch. 3AA inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Fertilisation and Embryology (Amendment) Regulations 2018 (S.I. 2018/334), regs. 1(3), 5(6)