Regulation 151 Amendment of regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)

(1)

Regulation 191 is amended as follows.

(2)

In paragraphs (1) and (7), for “EMA” substitute “licensing authority”.

(3)

In paragraph (2), insert “UK” before “marketing authorisation”.

(4)

In paragraph (3), omit—

(a)

“or an Article 126a authorisation” in both places it appears; and

(b)

“or Article 126a authorisation”.

(5)

After paragraph (4) insert—

“(4A)
A PSUR must also include the content, and be submitted in the format, specified in Part 8 of Schedule 12A.”.

(6)

After paragraph (8), insert—

“(8A)
In the case of a conditional marketing authorisation, the holder must submit PSURs immediately upon the request of the licensing authority and at least every six months beginning with the date on which the authorisation for the medicinal product is granted or renewed by the licensing authority.”.

(7)

In paragraph (10), for “within the EEA” in each place it appears substitute “in the United Kingdom”.

(8)

Omit paragraph (11).