Regulation 28 Amendment of regulation 37 (manufacturing and assembly)

(1)

Regulation 37^f1 is amended as follows.

(2)

In paragraph (4)(b)—

(a)

for “third country” substitute “country other than an approved country for import”; and

(b)

for “competent authority of a member State” substitute “appropriate authority for the registration of such persons in the approved country for import”.

(3)

In paragraph (5)(b), for “paragraph 5 of Article 47 of the 2001 Directive” substitute “the guidelines which apply under or by virtue of regulation C17”.

(4)

In paragraph (6)(b), for “marketing authorisations, Article 126a authorisations” substitute “UK marketing authorisations”.

(5)

In paragraph (9)(a), from “Commission” to the end substitute “the Blood Quality and Safety Regulations 2005^f2; or”.

(6)

In paragraph (11)—

(a)

for “competent authority of a member State” substitute “licensing authority”; and

(b)

insert “UK” before “marketing authorisation”.

Annotations

Footnotes

f1: Regulation 37 was substituted by S.I. 2013/1855.
f2: S.I. 2005/50. It has been amended by S.I. 2005/1098 and 2898, 2006/2013, 2007/604, 2008/525 and 941, 2009/372 and 3307, 2010/554, 2016/604, 2017/1320 and 2018/231.