OpenLegislation

Regulation 74 Amendment to paragraph 61

Original text. Later amendments are not shown.

In paragraph 61(1) (action taken on account of pharmacovigilance)—

(a)

after “a marketing authorisation” insert “, or a group of marketing authorisations containing the same active substance,”;

(b)

in paragraph (c)—

(aa)

after sub-paragraph (iv) omit “or”;

(bb)

after sub-paragraph (v) insert—

“or

(vi)

implement a risk management plan,”.