PART 5Amendment of Part 5 (marketing authorisations)
Amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence)I148
1
Regulation 49 M1 is amended as follows.
2
In paragraph (1), after “regulation 58,” insert “
58C, 58E, 58F and 58G,
”
.
3
After paragraph (1) insert—
F21A
The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a UKMA(GB) only where—
a
there is already in place, or will be at the time the UKMA(GB) is granted, a marketing authorisation in respect of the product authorising sale or supply in Northern Ireland,
b
the applicant complies with the requirements in regulation 50(1A), and
c
the medicinal product satisfies the definition of qualifying Northern Ireland goods.
F11B
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.
F31C
A marketing authorisation or parallel import licence must state whether it is in force in—
a
the whole United Kingdom;
b
Great Britain only; or
c
Northern Ireland only,
and in these Regulations the meaning of a reference to that authorisation or licence being “in force” is limited to that territory.
F44
For paragraph (3) substitute—
3
The applicant, where it is applying for—
a
a UKMA(NI)—
i
in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;
ii
on any other basis, must be established in the United Kingdom;
b
a UKMA(GB)—
i
under the unfettered access route, must be established in Northern Ireland;
ii
other than under the unfettered access route, must be established in the United Kingdom;
c
a UKMA(UK), must be established in the 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—
F69
The application must include a statement indicating whether the authorisation or licence sought is for sale or supply of the product in—
a
the whole United Kingdom;
b
Great Britain only; or
c
Northern Ireland only.