PART 3Amendments to Schedule 1 to the 2013 Regulations

Amendment to paragraph 6174

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,