The Medicines (Products for Animal Use — Fees) Regulations 1995

PART III Fees relating to applications for assistance in connection with mutual recognition applications

1.  Subject to paragraph 3, 4 and 5, where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table C is made within six months after the grant of the marketing authorisation to which it relates, and such application relates to an application for mutual recognition to be made to not more than five member States, the fee for such application shall be the fee specified in the corresponding entry in column (3) of that Table.

2.  Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table C is made within six months after the grant of the marketing authorisation to which it relates, and such application relates to an application for mutual recognition to be made to more than five member States, the fee for such application shall be the fee specified in the corresponding entry in column (3) of Table C, plus the additional fee specified in the corresponding entry in column (4) of that Table for the sixth and each additional member State.

3.  Where an application for assistance in connection with a mutual recognition application is made within six months after the grant of the marketing authorisation to which it relates, and an application or applications for assistance to mutually recognise such authorisation has or have previously been made by the applicant, no fee shall be payable in respect of the new application if the total number of member States to which the previous application or applications and the new application relate does not exceed five.

4.—(1) Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table C is made within six months after the grant of the marketing authorisation to which it relates, and—

(a) an application or applications for assistance mutually to recognise such authorisation has or have previously been made by the applicant; and

(b) the total number of member States to which the previous application or applications related does not exceed five but the total number of member States to which the previous application or applications related and the new application relates will exceed five,

a fee calculated in accordance with paragraph (2) shall be payable in connection with the new application.

(2) The fee payable in connection with an application to which subparagraph (1) applies shall be calculated by taking the total number of member States to which the previous application or applications related and the new application relates, deducting five from that number, and by then multiplying the resulting number by the fee specified in the corresponding entry in column (4) of Table C.

5.  Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table C is made within six months after the grant of the marketing authorisation to which it relates, and—

(a) an application or applications for assistance to mutually recognise such authorisation has or have previously been made by the applicant; and

(b) the total number of member States to which the previous application or applications related exceeds five, the fee payable in connection with the new application shall be calculated by multiplying the number of member States to which the new application relates by the fee specified in the corresponding entry in column (4) of that Table.

Table C

Column (1)	Column (2)	Column (3)	Column (4)
Kind of application	Previous fee	Basic fee	Additional Fee for the sixth and each additional member State
Major	N/A	£3,750	£700
Complex	N/A	£2,175	£336
Standard	N/A	£940	£175
Simple	N/A	£315	£60

6.—(1) Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table D is made more than six months after the grant of the marketing authorisation to which it relates, and such application relates to an application for mutual recognition to be made to not more than five member States, the fee for such application shall be the fee specified in the corresponding entry in column (3) of Table D.

(2) Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table D is made more than six months after the grant of the marketing authorisation to which it relates, and such application relates to an application for mutual recognition to be made to more than five member States, the fee for such application shall be the fee specified in the corresponding entry in column (3) of Table D plus, for the sixth and each additional member State, the fee specified in the corresponding entry in column (4) of that Table.

Table D

Column (1)	Column (2)	Column (3)	Column (4)
Kind of application	Previous fee	Basic fee	Additional Fee — for the sixth and each additional member State
Category I application	N/A	£7,975	£1,000
Category II application	N/A	£5,320	£665
Category III application	N/A	£4,255	£530