PART 11Amendment of Part 11 (Pharmacovigilance)

Amendment of regulation 195 (obligation on licensing authority to assess PSURs)I1155

1

Regulation 195 M1 is amended as follows.

2

In the heading, omit “where EU single assessment procedure does not apply”.

F12A

Before paragraph (1) insert—

A1

This regulation applies in the circumstances specified in paragraphs (1) and (1A).

2B

In paragraph (1)—

a

after “relating to a medicinal product” insert “authorised for sale or supply authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation”; and

b

in sub-paragraph (a)(i) omit “other than the United Kingdom”.

3

F2After paragraph (1) F3insert—

F4 1A

This regulation applies where PSURs relating to a medicinal product F5authorised for sale or supply under a UKMA(GB) or THR(GB) have been submitted to the licensing authority under regulations 191 to 192.

4

After paragraph (3) insert—

3A

If the licensing authority considers under paragraph (3)(b) that an authorisation or registration needs to be varied, it may require the holder to submit to the licensing authority, within a time period that the licensing authority specifies, an application for a variation, including—

a

an updated summary of the product characteristics; and

b

an updated package leaflet.

F65

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