Summary
Legal requirements referred to in Schedule 1 of the Veterinary Medicines Regulations, as amended.
The documentation accompanying an application for a marketing authorisation pursuant to Schedule 1 of the Veterinary Medicines Regulations shall be presented in accordance with the requirements set out in this Annex.
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Contents
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The documentation accompanying an application for a marketing authorisation pursuant to Schedule 1 of the Veterinary Medicines Regulations shall be presented in accordance with the requirements set out in this Annex.
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The following detailed requirements shall apply to veterinary medicinal products other than biological veterinary medicinal products, except where otherwise set out in Section IV.
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The following requirements shall apply to biological veterinary medicinal products except immunological products or where otherwise set out in Section IV.
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The following requirements shall apply to immunological veterinary medicinal products, except where otherwise set out in Section IV.
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The following detailed requirements shall apply to Requirements for Specific Marketing Authorisation Applications.
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This Section lays down specific requirements for identified veterinary medicinal products related to the nature of the active substances contained therein.