Division 10 In cases of applications for marketing authorisations for veterinary medicinal products indicated for animal species and indications representing smaller market sectors, a more flexible approach may be applicable. In such cases, relevant scientific guidelines and/or scientific advice should be taken into account.
United Kingdom
This Annex is divided in four titles:
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Title I describes the standardised requirements for applications for veterinary medicinal products other than immunological veterinary medicinal products.
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Title II describes the standardised requirements for applications for immunological veterinary medicinal products.
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Title III describes specific types of marketing authorisation dossiers and requirements.
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Title IV describes the dossier requirements for particular types of veterinary medicinal products.
Notes on Annex II
Footnotes
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This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.