Failure to place on the market etcU.K.
109.—(1) A certificate of registration ceases to be in force if the product to which it relates is not placed on the market in the United Kingdom [F1(or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain)] during the period of three years beginning immediately after the day on which it was granted.
(2) A certificate of registration for a product which has been placed on the market ceases to be in force if the product to which it relates is not sold or supplied in the United Kingdom [F2(or, in the case of a COR(GB) granted after an application under the unfettered access route, in Great Britain)] for a period of three years.
(3) This regulation does not apply if the licensing authority grants an exemption from its operation.
(4) An exemption may be granted—
(a)in response to an application in writing by the holder of the certificate of registration; or
(b)by the licensing authority of its own motion.
(5) An exemption may be granted only—
(a)in exceptional circumstances; and
(b)on public health grounds.
(6) An exemption—
(a)has effect for the period determined by the licensing authority, which may not exceed three years beginning with the day on which it is granted; and
(b)may be renewed or further renewed.
Textual Amendments
F1Words in reg. 109(1) inserted (31.12.2020) by S.I. 2019/775, reg. 101A(2) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 79)
F2Words in reg. 109(2) inserted (31.12.2020) by S.I. 2019/775, reg. 101A(3) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 79)