SCHEDULE 7Fees

PART 2Fees relating to marketing authorisations

F1Application for a marketing authorisation for a pharmaceutical F6, immunological or biological that is not immunological veterinary medicinal productE17

The following table sets out the fees relating to a pharmaceutical F5, immunological or biological that is not immunological veterinary medicinal product for—

a

F2an application for a marketing authorisation that is—

i

a full application under Part 1 of Schedule 1; F11or

ii

a bibliographic application F8for a pharmaceutical veterinary medicinal product; F9...

F10iii

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7Application

Fee (£) per authorisation

Base fee

27,995

Fee for 1st additional strength

4,590

Fee for each subsequent additional strength

1,465

Specified pharmaceutical applicationsE27

The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—

a

a national application for a marketing authorisation that is—

i

a full application under Part 1 of Schedule 1;

ii

a bibliographic application; or

iii

an application based on pharmacological equivalence;

b

an application for a marketing authorisation using the decentralised procedure where the United Kingdom is a concerned member State;

c

an application for the mutual recognition of a product authorised in another member State.

Application

Full national application under Part 1 of Schedule 1 (£)

Bibliographic national application (£)

Pharmacologically equivalent national application

Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)

Reference product authorised in UK (£)

Reference product not authorised in UK (£)

Base Fee:

13,530

12,115

7,195

9,220

6,515

Additional fee if any of the target species is a food-producing animal:

3,905

3,585

2,155

2,760

1,415

Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—

food-producing animal:

7,465

6,595

5,885

7,495

2,630

non-food-producing animal:

6,525

5,855

5,590

7,155

2,295

Additional fee for each additional pack type:

740

740

605

775

330

Additional fee for each additional active ingredient (food-producing animal):

6,465

6,125

4,040

5,165

2,085

Additional fee for each additional active ingredient (non-food-producing animal):

4,310

4,105

3,235

4,135

1,475

Additional fee if there is more than one target species, for each additional species (food-producing animal):

3,970

3,565

2,425

3,100

1,280

Applies for a maximum of 2 additional species

Additional fee if there is more than one target species, for each additional species (non- food-producing animal):

2,495

2,090

1,550

1,980

805

Applies for a maximum of 2 additional species

Additional fee for each additional recommended route of administration (food-producing animal):

2,695

2,490

1,620

2,070

940

Additional fee for each additional recommended route of administration (non- food-producing animal):

1,215

1,010

740

945

405

Simultaneous applications: fee for each additional product in the application:

2,895

2,895

2,895

3,705

1,685