PART 5Amendment of Part 5 (marketing authorisations)
Amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence)48
1
Regulation 4945 is amended as follows.
2
In paragraph (1), after “regulation 58,” insert “58C, 58E, 58F and 58G,”.
3
After paragraph (1) insert—
1A
The licensing authority may only grant a parallel import licence if it is able to obtain the information necessary, whether from a competent authority of an EEA State or otherwise, to satisfy itself that the medicinal product to be imported—
a
has been granted an EU marketing authorisation or a marketing authorisation under the 2001 Directive; and
b
is essentially similar to a product that has already been granted a UK marketing authorisation.
4
In paragraph (3), for “European Union” substitute “United Kingdom.”
5
After paragraph (3) insert—
3A
An application for a parallel import licence may not be made by—
a
the holder of the marketing authorisation, within the meaning of the 2001 Directive, or the EU marketing authorisation, in respect of the relevant medicinal product to be imported; or
b
a company which is in the same group as the holder of that marketing authorisation.
6
At the end insert—
9
In this regulation “group” has the same meaning as in Part 15 of the Companies Act 200646 (see section 474(1) of that Act).