Paragraph 2 Classification of variationsF1

(1)

Except where sub-paragraph (2) applies, a variation which is not an extension, and whose classification is undetermined after—

(a)

application of the provisions in this Schedule; and

(b)

taking into account—

(i)

the guidance referred to in regulation 65C(4) or (6) as the case may be), and

(ii)

where relevant, any recommendations delivered pursuant to paragraph 3,

is to be treated by the licensing authority as a minor variation of type IB.

(2)

The licensing authority must treat a variation that would otherwise fall within sub-paragraph (1) as a major variation of type II in the following cases—

(a)

upon request from the holder when submitting the variation; or

(b)

where the licensing authority concludes, following the assessment of validity of a notification in accordance with paragraph 7(1), and taking into account the recommendations given under paragraph 3, that the variation may have a significant impact on the quality, safety or efficacy of the medicinal product concerned.

Annotations

Textual amendments

F1: Sch. 10A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 5; 2020 c. 1, Sch. 5 para. 1(1)