Regulation 165 New paragraph 7A

After paragraph 7 insert—

“Application for a marketing authorisation for specific applications

7A.

The fee for an application for a marketing authorisation which involves one or more of the following is £45,000—

(a)

any biotechnical process involving recombinant DNA or the controlled expression of genes;

(b)

a veterinary medicinal product containing a new active substance;

(c)

a biopharmaceutical product.”.