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 ”.