The Human Medicines Regulations 2012

[F1Applications for renewals of conditional marketing authorisations made after IP completion dayU.K.

This adran has no associated Memorandwm Esboniadol

17.—(1) This paragraph applies where the holder of a converted EU marketing authorisation which was granted as a conditional marketing authorisation within the meaning of Article 1 of Regulation (EC) No 507/2006 is due to make an application for renewal of the authorisation in accordance with regulation 66B during the period beginning with IP completion day and ending on the data submission date.

(2) Where this paragraph applies—

(a)the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the baseline data so that it is received by the licensing authority at the same time as the application for renewal is made;

(b)the licensing authority must consider the renewal application in accordance with regulation 66B (renewal of conditional marketing authorisation); and

(c)the authorisation remains in force until the licensing authority notifies the holder of its decision on the renewal application.]

Textual Amendments