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

PART III FEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS

1.  Subject to paragraphs 3 and 4, where an application for assistance in connection with a mutual recognition application of a kind described in an entry 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 (2) of that Table.

2.  Where an application for assistance in connection with a mutual recognition application of a kind described in an entry 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 (2) of Table C, plus the additional fee specified in the corresponding entry in column (3) of that Table for the sixth and each additional member State.

3.  Where an application for assistance in connection with a mutual recognition application of a kind described in an entry in column (1) of Table C is made within six months after the grant of the marketing authorisation to which it relates, and an application for such assistance in respect of the same authorisation has 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 and the new application relate does not exceed five.

4.  Where an application for assistance in connection with a mutual recognition application of a kind described in an entry 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 for such assistance in respect of the same authorisation has previously been made by the applicant; and

(b) the total number of member States to which the previous application related exceeds five,

the fee in column (3) of Table C shall be payable for the sixth and each additional member State exceeding five to which the new application relates.

Table C

Column (1)	Column (2)	Column (3)
Kind of application	Basic fee	Additional Fee for the sixth and each additional member State
Major	£3,250	£700
Complex	£2,175	£340
Standard	£940	£175
Simple	£315	£60

5.—(1) Where an application for assistance in connection with a mutual recognition application of a kind described in an entry 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, subject to sub-paragraph (3) below, be the fee specified in the corresponding entry in column (2) of Table D.

(2) Where an application for assistance in connection with a mutual recognition application of a kind described in an entry 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, subject to sub-paragraph (3) below, be the fee specified in the corresponding entry in column (2) of Table D plus, for the sixth and each additional member State, the fee specified in the corresponding entry in column (3) of that Table.

(3) 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 an application for such assistance in respect of the same authorisation has previously been made by the applicant, the fee specified in the corresponding entry in column (3) of Table D shall be payable for each additional member State which was not covered by the previous application.

Table D

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