Paragraph 51

in paragraph (2), in the inserted paragraph (4)(b), before “to comply” insert “in relation to a UKMA(GB),”;

after paragraph (2) insert—

“(2A)

In paragraph (6), after “one medicinal product” insert “authorised by a UKMA(NI) or UKMA(UK)”.”;

for paragraph (3) substitute—

“(3)

After paragraph (6) insert—

“(6A)

If concerns as described in paragraph (2) apply to more than one medicinal product authorised by a UKMA(GB), the licensing authority—

(a)

must, where the obligation is to conduct a post-authorisation safety study, encourage the UK marketing authorisation holders concerned to conduct a joint study, and

(b)

may, where the obligation is to comply with any other conditions or restrictions, encourage the UK marketing authorisation holders concerned to take co-ordinated action to comply with the conditions or restrictions.”.”;

after paragraph (3) insert—

“(3A)

In paragraph (7) for “The obligation under paragraph (5) shall” substitute “In relation to a UKMA(NI) or UKMA(UK), the obligation under paragraph (5) must”.”;

for paragraph (4) substitute—

“(4)

After paragraph (7) insert—

“(7A)

In relation to a UKMA(GB), the obligation under paragraph (5) must—

(a)

be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive; and

(b)

take into account the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.

(7B)

The Secretary of State may by regulations make provision in respect of Great Britain specifying the situations in which post-authorisation efficacy studies may be required by virtue of the obligation under paragraph (5).

(7C)

Paragraph (7A)(a) ceases to apply on the coming into force of regulations made under paragraph (7B).”.”;

for paragraph (5) substitute—

“(5)

In paragraph (13), after “notify the EMA” insert “, in relation to a UKMA(NI) or UKMA(UK),”.”.