The Veterinary Medicines Regulations 2008

PART 1 Introduction

Interpretation

1.  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—

(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

(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.

Payment of fees

2.  All fees under this Schedule are payable to the Secretary of State.

Time of payment

3.  All fees are payable on invoice unless otherwise specified.

Multiple inspections

4.  If a site is inspected for more than one type of authorisation at the same time, only one fee (the highest) is payable.

Expenses for inspections

5.  Whenever premises are inspected, the travel and subsistence costs of the inspectors and, in the case of an inspection outside the United Kingdom, interpreters’ fees are payable in addition to the inspection fee specified.

Translation

6.  All translation costs are charged additionally.