Legal requirements referred to Article 8(1), Point (B) 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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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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Requirements for Biological Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products.
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Requirements for Immunological Veterinary Medicinal Products.
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Requirements for Specific Marketing Authorisation Applications.
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Requirements for Marketing Authorisation applications for particular veterinary medicinal products.