Regulation 63 Amendment of Schedule 11 (advice and representations)

(1)

Schedule 11 is amended as follows.

(2)

In paragraph 1 (application of Part 1)—

(a)

in sub-paragraph (1)—

(i)

in sub-paragraph (b) omit “and”, and

(ii)

at the end insert—

“(d)
a proposal to agree, or to refuse to agree, a paediatric investigation plan;

(e)
a proposal to grant, or to refuse to grant, or to revoke, a waiver or deferral of the initiation or completion of some or all of the measures set out in a paediatric investigation plan; and

(f)
a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.”;

(b)

after sub-paragraph (1) insert—

“(1A)
Paragraphs 12 and 13 of this Part also apply to—

(a)
an application for the grant of a parallel import licence;

(b)
an application to renew a parallel import licence;

(c)
a proposal to revoke, vary or suspend a parallel import licence (including variation by the variation or removal of a condition to which a parallel import licence is subject) other than a proposal to vary the licence on the application of or by agreement with its holder; and

(d)
a refusal to vary a parallel import licence following an application for a variation by the holder.”; and

(c)

omit sub-paragraph (2).

(3)

In paragraph 12 (licensing authority decision in other cases), in sub-paragraphs (1), (2) and (5)—

(a)

insert “, parallel import licence” after “UK marketing authorisation” in each place it appears; and

(b)

insert “, licence” after “the authorisation” in each place it appears.

(4)

In paragraph 14(a) (application of Part 2), for the words from “Article 2(3)” to the end, substitute “paragraph 1 of Schedule 10A; and”.

(5)

In paragraph 15(2) and (3)(b), insert “UK” before “marketing authorisation”.

(6)

In paragraph 16—

(a)

in sub-paragraph (2)(b), insert “UK” before “marketing authorisation”; and

(b)

in sub-paragraph (5), omit the words from “or in any Directive” to the end.

(7)

Omit paragraph 17.

(8)

In Part 3 (referral to the Committee for Herbal Medicinal Products)—

(a)

in the heading to Part 3, for “Committee for Herbal Medicinal Products” substitute “appropriate committee for traditional herbal registrations”;

(b)

in paragraph 24—

(i)

in sub-paragraph (1), for the words from “Committee” to the end substitute “appropriate committee in accordance with regulation 130A(1)”; and

(ii)

omit sub-paragraph (2); and

(c)

in paragraph 29(1), for “proceed with its proposal” substitute “grant or refuse the application”.

(9)

Omit Part 4 (exceptions to Schedule).