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SCHEDULES

[F1SCHEDULE 33AU.K.Transitional provision in relation to EU Exit

PART 5U.K.Transitional provision in relation to variations of marketing authorisations other than converted EU marketing authorisations

Application or notification made before IP completion day in respect of a variation under Chapter IIa of Regulation (EC) No 1234/2008 (variations to purely national marketing authorisations)U.K.

38.(1) Sub-paragraph (2) applies where—

(a)an application or notification in respect of a variation to a UK marketing authorisation has been submitted to the licensing authority under Chapter IIa of Regulation (EC) No 1234/2008 before IP completion day; but

(b)the procedures specified in Article 13e of that Regulation (measures to close the variation procedures in Chapter IIa of that Regulation) have not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must—

(a)determine which of the provisions specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the steps that have already been undertaken under Chapter IIa of Regulation (EC) No 1234/2008 before IP completion day;

(b)assess the application or notification in accordance with the provisions of that Schedule the authority has determined are relevant to the application, as if the application or notification had been made under them; and

(c)take all reasonable steps to ensure that it assesses the notification or application in accordance with any relevant time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

(3) Paragraphs 15 and 16 of Schedule 10A apply to any variation that falls under sub-paragraph (1)(a) or (b).

Application or notification made before IP completion day in respect of a variation under Chapter II of Regulation (EC) No 1234/2008 (variations to marketing authorisations granted in accordance with Chapter 4 of the 2001 Directive)U.K.

39.(1) This paragraph applies where an application or notification in respect of a variation to a marketing authorisation has been submitted to the licensing authority, as a relevant authority, under Chapter II of Regulation (EC) No 1234/2008 before IP completion day.

(2) If the procedures specified in Article 11(1) of Regulation (EC) No 1234/2008 have not concluded before IP completion day, the licensing authority must—

(a)assess the application or notification in accordance with regulation 65C and Schedule 10A to these Regulations, as if the application or notification had been made under those provisions; and

(b)make such an assessment having regard to the matters specified in sub-paragraph (5).

(3) If the procedures specified in Article 11(1) of Regulation (EC) No 1234/2008 have concluded before IP completion day—

(a)the licensing authority must take the steps specified in Article 11(2) of Regulation (EC) No 1234/2008 within the time limit specified in Article 23(1) of that Regulation; and

(b)paragraphs 15 and 16 of Schedule 10A apply to the variation.

(4) In making a determination under sub-paragraph (2), the licensing authority must—

(a)determine which steps of the procedures specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the matters specified in sub-paragraph (5); and

(b)take all reasonable steps to ensure that it assesses the notification or application in accordance with any time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

(5) In making a determination under sub-paragraph (2), the licensing authority must have regard to—

(a)any recommendation in relation to that application or notification given before IP completion day pursuant to Article 5 of Regulation (EC) No 1234/2008;

(b)any relevant information obtained by it before IP completion day, as a relevant authority, in relation to the application or notification by virtue of any procedure provided for in Chapter II of that Regulation; and

(c)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a relevant authority, including any matter referred under the procedure specified in Article 13 of that Regulation.

Application or notification in respect of a variations made before IP completion day under Article 20 of Regulation (EC) No 1234/2008 (work-sharing procedure)U.K.

40.(1) Sub-paragraph (2) applies where—

(a)an application or notification in respect of a variation to a UK marketing authorisation has been submitted to the licensing authority, as a relevant authority or the reference authority, under Article 20 of Regulation (EC) No 1234/2008;

(b)the marketing authorisation is one to which Chapter II or IIa of that Regulation applied; and

(c)the procedure in Article 20(8) has not been completed before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must—

(a)determine which of the provisions specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the steps that have already been undertaken under Article 20 of Regulation (EC) No 1234/2008 before IP completion day;

(b)assess the application or notification in accordance with the relevant provisions in that Schedule, as if the application or notification had been made under them; and

(c)take all reasonable steps to ensure that it assesses the notification or application in accordance with any relevant time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

(3) In making a determination or assessment under sub-paragraph (2), the licensing authority must have regard to—

(a)any opinion given by the reference authority before IP completion day in relation to that application;

(b)any relevant information obtained by it before IP completion day, as a reference authority or relevant authority, in relation to the application or notification by virtue of any procedure provided for in regulation 20 of Regulation (EC) No 1234/2008; and

(c)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a relevant authority.

(4) Paragraphs 15 and 16 of Schedule 10A apply to any variation that falls under sub-paragraph (1).]