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The Medicines (Products for Human Use) (Fees) Regulations 2010

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46.—(1) Unless paragraph 47 or 48 applies, where more than one application—

(a)of a type referred to in sub-paragraph (2) is made at the same time by the same marketing authorization holder and all of the applications are for identical kinds of variations; or

(b)by the same applicant is made at the same time for a traditional herbal registration, a manufacturer’s licence, or a wholesale dealer’s licence and where the applications are for identical variations,

the fee payable under regulation 18(1) is that specified in sub-paragraph (3).

(2) The type of application referred to in sub-paragraph (1) is a—

(a)Type IB Application;

(b)Type II Application;

(c)Minor Variation (Type IB) Group Application; or

(d)Major Variation (Type II) Group Application.

(3) The fee referred to in sub-paragraph (1)—

(a)in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of this Schedule; and

(b)in connection with each of the other applications is 50% of that amount.

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