SCHEDULE 7FEES

PART 1Introduction

Interpretation of Schedule 71

In this Schedule—

  • “national application” means an application for a marketing authorisation that does not involve another member State;

  • “pharmaceutical product” means any veterinary medicinal product other than an immunological product;

  • “simultaneous application” is an application in which, at the time an authorisation for a product is applied for, one or more additional applications are submitted for products that are identical to the first product except that—

    1. a

      in the case of an immunological product, they have a lesser number of antigens than the first product, but only contain antigens contained in the first product; and

    2. b

      in the case of a pharmaceutical product, they have different strengths of the active substance, and, in the case of an application involving more than one member State, the additional applications do not include a member State that was not included in the first application.