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The Veterinary Medicines Regulations 2013

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Application for a variation to a marketing authorisation dealt with under worksharing proceduresE+W+S

This section has no associated Explanatory Memorandum

18.—(1) This paragraph applies in relation to an application for a variation to a marketing authorisation dealt with in accordance with worksharing procedures as set out in Article 20 of Commission Regulation (EC) No 1234/.

[F1(2) The fees for a worksharing application are specified in the following table.]

F2(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F2(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F2(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Type of applicationF3...F4...F4...
F4...F4...F4...F4...F4...F4...

Worksharing applications

The following fees apply for each change to each product:

Type II
For the first nine changes:6,240F4...F4...F4...F4...F4...F4...
For each subsequent group of up to ten changes:4,500F4...F4...F4...F4...F4...F4...
Type IB...
For the first nine changes:1,770F4...F4...F4...F4...F4...F4...
For each subsequent group of up to ten changes:4,500F4...F4...F4...F4...F4...F4...

Textual Amendments

Application for a variation to a marketing authorisation dealt with under worksharing proceduresN.I.

18.—(1) This paragraph applies in relation to an application for a variation to a marketing authorisation dealt with in accordance with worksharing procedures as set out in Article 20 of Commission Regulation (EC) No 1234/.

(2) The fee for a worksharing application, involving marketing authorisations obtained by a national procedure in the United Kingdom only, is the fee specified in the following table in the column headed “UK Only”.

(3) The fee for a worksharing application, involving marketing authorisations obtained through a national procedure in the United Kingdom and any other member State, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “Other”.

(4) The fee for a worksharing application, involving at least one marketing authorisation obtained through the mutual recognition or decentralised procedure, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “UK Concerned member State”.

(5) The fee for any kind of variation where the Agency co-ordinates worksharing is £455 for each marketing authorisation.

Type of applicationUK OnlyWhere the application involves nationally authorised products in more than one member StateApplication involves mutually recognised products

UK

Only

UK Reference Authority

UK

Co-Reference

Authority

Other

UK

Reference Authority

UK

Co-Reference Authority

UK

Concerned member State

Worksharing applications

The following fees apply for each change to each product:

Type II
For the first nine changes:6,24012,0607,48512,06013,2656,7453,372
For each subsequent group of up to ten changes:4,5004,5004,5004,5004,5004,5002,700
Type IB
For the first nine changes:1,7702,6502,1202,6502,9151,905954
For each subsequent group of up to ten changes:4,5004,5004,5004,5004,5004,5002,700

Extent Information

E1This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

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