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The Veterinary Medicines Regulations 2013

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PART 1U.K.Introduction

InterpretationE+W+S

1.— [F1(1)]  In this Schedule—

F2...

“pharmaceutical product” means any veterinary medicinal product other than an immunological product [F3or a biological veterinary medicinal product that is not immunological];

“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,

F4...

[F5(2) For the purposes of this Schedule “manufacturing authorisation” means the following activities—

(a)manufacture or import of an authorised veterinary medicinal product;

(b)manufacture of a product to which paragraph 2 of Schedule 6 relates;

(c)manufacture of a product for administration under the cascade;

(d)manufacture of—

(i)an autogenous vaccine;

(ii)a stem cell product; or

(iii)a blood product for administration to non-food animals.]

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1Sch. 7 para. 1 renumbered as Sch. 7 para. 1(1) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 162(a)

InterpretationN.I.

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.

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Payment of feesU.K.

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

Time of paymentU.K.

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

Multiple inspectionsU.K.

4.  If a site, premises or establishment is inspected for more than one type of authorisation [F6, approval] or registration at the same time, [F7and in relation to the same legal entity,] the fee is the sum of—

(a)the highest fee payable; and

(b)50% of each of the other fees.

Textual Amendments

Expenses for inspections outside the United KingdomU.K.

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

TranslationU.K.

6.  All translation costs are charged additionally.

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