Title II Requirements for immunological veterinary medicinal products
United Kingdom
Without prejudice to specific requirements laid down by Community legislation for the control and eradication of specific infectious animal diseases, the following requirements shall apply to immunological veterinary medicinal products, except when the products are intended for use in some species or with specific indications as defined in Title III and in relevant guidelines.
- 1Summary of the dossier
- 2Chemical, pharmaceutical and biological/microbiological information (quality)
- 3Safety tests
- 4Efficacy tests
- 5Particulars and documents
- 6Bibliographical references
Notes on Annex II
Footnotes
- f1
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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.