Paragraph 21 Article 61(3) notifications sought in advance of the data submission dateF1

(1)

If a holder of a converted EU marketing authorisation wishes to notify the licensing authority of a proposed change to an aspect of the labelling or the package leaflet of the EU marketing authorisation to which the converted EU marketing authorisation relates in advance of the data submission date, the holder must—

(a)

submit the notification of the proposed change to the licensing authority; and

(b)

unless sub-paragraph (2) applies, at the same time provide the licensing authority with such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing by the licensing authority for this purpose and published on or before IP completion day.

(2)

If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a proposed change before the data submission date but does not provide the information described in sub-paragraph (1)(b) with the notification, the licensing authority may agree to consider the notification if it is satisfied that—

(a)

the proposed change may be necessary on urgent safety grounds;

(b)

the proposed change may be necessary in order to maintain supplies of a particular medicinal product to patients in the United Kingdom; or

(c)

there are other good reasons for considering the proposed change in advance of the data submission date.

(3)

Where the licensing authority considers a proposed change in accordance with this paragraph, the references in paragraph 19(2)(c) and 20(2)(c) to the data submission date are to be read as references to the date on which—

(a)

the proposed change is notified to the licensing authority in accordance with sub-paragraph (1); or

(b)

the licensing authority notifies the holder that it will consider the notification, in accordance with sub-paragraph (2), without the information referred to in sub-paragraph (1)(b).

Annotations

Textual amendments

F1: Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)