The Medicines (Products for Human Use) (Fees) Regulations 2012

Fees for variations of certificates

42.—(1) The fee payable by an applicant in connection with an application for an administrative variation of a certificate of registration shall be—

(a) where more than one application for an administrative variation is made at the same time by the same applicant and the applications are for identical variations—

(i) in respect of the first application considered by the licensing authority, a fee of £133, and

(ii) in respect of each other application so considered, a fee of £67;

(b) in any other case, a fee of £133.

(2) The fee payable by an applicant in connection with an application for a standard variation of a certificate of registration shall be—

(a) where more than one application for a standard variation is made at the same time by the same applicant and the applications are for identical variations—

(i) in respect of the first application considered by the licensing authority, a fee of £263;

(ii) in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £263;

(iii) in respect of the second to thirtieth applications so considered, where no further medical, technical or scientific assessment is required, a fee of £133;

(iv) in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £67;

(b) in any other case, a fee of £263.