Paragraph 16 Amendment of the Branded Health Service Medicines (Costs) Regulations 2018

(1)

The Branded Health Service Medicines (Costs) Regulations 2018^f1 are amended as follows.

(2)

In regulation 1(2) (interpretation)—

(a)

in the definition of “marketing authorisation” insert “UK” before “marketing” and re-insert the definition at the appropriate place;

(b)

in the definition of “marketing authorisation holder” insert “UK” before “marketing” in and re-insert the definition at the appropriate place;

(c)

omit the definition of “parallel distributed presentation”;

(d)

in paragraph (b) of the definition of “relevant medicine” insert “UK” before “marketing authorisation”; and

(e)

in the definition of “supplementary protection certificate” omit from “means” to the end and insert “has the meaning given by section 128B(2) of the Patents Act 1977”.

(3)

In regulation 3 (payment scheme)—

(a)

in paragraph (3)(a), insert “UK” before “marketing authorisation holder”;

(b)

omit paragraph (4)(c).

(4)

In regulation 9 (new presentation)—

(a)

in paragraph (10)—

(i)

in sub-paragraph (a), insert at the beginning “in relation to a product in respect of which there is a converted EU marketing authorisation”,

(ii)

in sub-paragraph (b), for “Article 21” to the end substitute “regulation 64(6) of the 2012 Regulations”; and

(b)

in paragraph (12), insert before the definition of “licensing authority”—

““converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the 2012 Regulations;”.

(5)

In regulation 21 (sales report), omit paragraph (1)(h).

(6)

In regulation 22 (presentation report), omit sub-paragraph (h).

Annotations

Footnotes

f1: S.I. 2018/345.