The Medicines (Products for Animal Use—Fees) Regulations 1997

PART IV FEES RELATING TO APPLICATIONS FOR THE VARIATION OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES

Marketing authorisations (other than mutually recognised marketing authorisations) and product licences

1.  The fee for a complex application for the variation of—

(a) a marketing authorisation, other than a mutually recognised marketing authorisation, or

(b) a product licence,

shall be £2,640

2.  The fee for an application of the kind described in column (1) of Table E for the variation of—

(a) a marketing authorisation, other than a mutually recognised marketing authorisation; or

(b) a product licence,

other than a complex application shall be that specified in the corresponding entry in column (2) of that Table.

Table E

Column (1)	Column (2)
Kind of application	Fee
Variation requiring veterinary, scientific or pharmaceutical assessment	£375 for the first variation plus £155 for each additional consequential variation to other authorisations or licences in identical terms
Variation not requiring veterinary, scientific or pharmaceutical assessment	£155
Variation involving the re-issue of the licence in the new name of the company	£155
Variation where the product licence relates solely to an emergency vaccine	£40

3.  The fee for an application for the variation of a mutually recognised marketing authorisation of a kind described in column (1) of Table F shall be that specified in the corresponding entry in column (2) of that Table where the United Kingdom is acting as the reference member State and that specified in the corresponding entry in column (3) of the said Table where the United Kingdom is not acting as the reference member State—

Table F

Column (1)	Column (2)	Column (3)
Kind of application	New fee—United Kingdom acting as the reference member State	New fee—United Kingdom not acting as the reference member State
Type I variation—Administrative	£530	£100
Type I variation—scientific	£2,130	£500
Type II variation	£7,445	£2,000
New application treated as a variation	£8,510	£3,560

Manufacturer’s licences

4.  The fee for an application for variation of a manufacturer’s licence—

(a) in the case of a manufacturer’s licence referred to in paragraph 7(2) of Part II of this Schedule, shall be £95;

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £360; and

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £120.

Wholesale dealer’s licences

5.  The fee for an application for variation of a wholesale dealer’s licence—

(a) requiring veterinary, scientific or pharmaceutical assessment, shall be £360; and

(b) not requiring veterinary, scientific or pharmaceutical assessment, shall be £120.

Animal test certificates

6.  The fee for an application for the variation of an animal test certificate shall be £200.