Regulation 11 Amendment of regulation 68

Regulation 68 (revocation, variation and suspension of UK marketing authorisation) is amended as follows.

For paragraph (4) substitute—

“(4)

Condition C is that the licensing authority thinks that there has been a breach of—

(a)

a term of the authorisation or licence;

(b)

in the case of a UK marketing authorisation, a requirement imposed by Part 13 (packaging and leaflets); or

(c)

in the case of a parallel import licence, a requirement in relation to packaging and leaflets imposed by the licensing authority.”

For paragraph (5) substitute—

“(5)

Condition D is that the licensing authority thinks that a condition to which—

(a)

the UK marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of UK marketing authorisations or parallel import licence: general); or

(b)

the UK marketing authorisation is subject by virtue of regulations 60 (conditions of UK marketing authorisations: exceptional circumstances) or 61 (conditions of UK marketing authorisations: new obligations post-authorisation),

has not been fulfilled.”

In paragraph (13) for “This” substitute “Except in the case of a parallel import licence, this”.