SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 4Amendment of Part 5 (amendment of Part 5 (marketing authorisations))
I138
In regulation 50 (amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation))—
a
in paragraph (2)—
i
in paragraph (a), after “in the United Kingdom” insert “
or a member State
”
;
ii
for paragraph (b) substitute—
b
for sub-paragraph (b) substitute—
b
the country (which must be either the United Kingdom or a member State) in which the appropriately qualified person resides and carries out his or her tasks;
iii
for paragraph (c) substitute—
c
for paragraph (e) substitute—
e
a reference to the physical location where the pharmacovigilance system master file for the medicinal product can be accessed electronically, which must be in the United Kingdom.
b
in paragraph (3), for the inserted paragraph 18, substitute—
18
Where—
a
in the case of a UKMA(NI) or a UKMA(UK), an application for authorisation for the medicinal product to be placed on the market is under consideration in one or more member States—
i
a list of the member State or States concerned, and
ii
in relation to each such application, a copy of the summary of the product characteristics, and the package leaflet, proposed by the applicant;
b
in the case of a medicinal product for sale or supply in Great Britain, an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.
c
for paragraph (4) substitute—
4
In paragraph 19, for “a member State or by a third country” substitute
“ , in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission ”.
d
for paragraph (5) substitute—
5
In paragraph 20, after “Where” insert
“ , in the case of a medicinal product for sale or supply in Northern Ireland, ”.
e
for paragraph (6) substitute—
6
For paragraph 21 substitute—
21
Where an authorisation for the medicinal product to be placed on the market has been refused—
a
in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or
b
in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,
details of that decision and of the reasons for it.
f
for paragraph (7) substitute—
7
In paragraph 22 for “A copy of any” substitute
“ In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any ”.
g
for paragraph (8) substitute—
8
For paragraph 23 substitute—
23
For medicinal products included on the list referred to—
a
in the case of a medicinal product for sale or supply in Northern Ireland, in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or
b
in the case of a medicinal product for sale or supply in Great Britain, in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.
h
in paragraph (9), in the inserted paragraph 25A, after “advanced therapy medicinal product ” insert “
for sale or supply in Great Britain
”
;
i
in paragraph (10), in the inserted paragraph 36, after “advanced therapy medicinal product ” insert “
for sale or supply in Great Britain
”
.