PART 4Amendment of Part 4 (requirement for authorisation)
Amendment of regulation 46 (requirement for authorisation)45
1
Regulation 46 is amended as follows.
2
In paragraph (2)—
a
in sub-paragraph (a), before “marketing authorisation”, insert “UK”;
b
at the end of sub-paragraph (b), insert “or”; and
c
omit sub-paragraph (d) (and “or” immediately preceding it).
3
In paragraph (3), before “European Economic Area” insert “United Kingdom or the”.
4
In paragraph (6)—
a
in sub-paragraph (a), before “marketing authorisation”, insert “UK”;
b
at the end of sub-paragraph (b), insert “or”; and
c
omit sub-paragraph (d) (and “or” immediately preceding it).
5
In paragraph (7), omit sub-paragraph (b) (and “and” immediately preceding it).
6
In paragraph (9), before “European Economic Area” insert “United Kingdom or the”.
7
In paragraph (11)(a), before “European Economic Area” insert “United Kingdom or the”.
Amendment of regulation 47 (breach of requirement)46
1
Regulation 47 is amended as follows.
2
In paragraphs (3) and (4), before “European Economic Area”, insert “United Kingdom or the”.
3
In paragraph (6), for “marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation”, substitute “UK marketing authorisation, certificate of registration or traditional herbal registration”.