The Medicines (Products for Animal Use—Fees) Regulations 1998

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,

is £2,000 in respect of each individual variation.

2.  The fee for an application of a kind described in an entry 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, is 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 (where the authorisation or licence is not related solely to an emergency vaccine)	£500 for each individual variation in that application plus £200 for each additional consequential individual variation to other authorisations or licences in identical terms
Variation not requiring veterinary, scientific or pharmaceutical assessment (where the authorisation or licence is not related solely to an emergency vaccine)	£200 in respect of each individual variation
Variation where the authorisation or licence relates solely to an emergency vaccine	£40 in respect of each individual variation

Mutually recognised marketing authorisations

3.  Subject to paragraph 4, the fee for an application for the variation (of a kind described in an entry in column (1) of Table F) of a mutually recognised marketing authorisation shall, in respect of each individual variation to which the application relates, 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	Fee–United Kingdom acting as the Reference Member State	Fee–United Kingdom not acting as the Reference Member State
Type I variation—Administrative	£530	£100
Type I variation—Scientific	£2,130	£500
Type I variation, Scientific—Type II procedure	£3,500	£1,000
Type II variation	£7,445	£2,000
Variation with extras	£8,510	£3,560

4.  The fee for an application for a connected variation, that is to say a variation (of a kind described in an entry in column (1) of Table F) of a mutually recognised marketing authorisation which is consequential on, additional and in identical terms to an actual or proposed variation of another such authorisation covered both by the same applicant and by a fee paid in pursuance of paragraph 3 shall, in respect of each connected variation to which the application relates, be £530 per individual variation where the United Kingdom is acting as the Reference Member State and £100 per individual variation where the United Kingdom is not acting as Reference Member State.

Manufacturer’s licences

5.  The fee for an application for the variation of a manufacturer’s licence–

(a) in the case of a manufacturer’s licence referred to in paragraph 6(2) of Part II of this Schedule, is £95, and

(b) in any other case–

(i) requiring veterinary, scientific or pharmaceutical assessment, is £360, and

(ii) not requiring veterinary, scientific or pharmaceutical assessment, is £120,

in respect of each individual variation.

Wholesale dealer’s licences

6.  The fee for an application for the variation of a wholesale dealer’s licence–

(a) requiring veterinary, scientific or pharmaceutical assessment, is £360, and

(b) not requiring veterinary, scientific or pharmaceutical assessment, is £120,

in respect of each individual variation.

Animal test certificates

7.  The fee for an application for the variation of an animal test certificate is £200 in respect of each individual variation.