Title I Requirements for veterinary medicinal products other than immunological veterinary medicinal products
United Kingdom
The following requirements shall apply to veterinary medicinal products other than immunological veterinary medicinal products, except where otherwise set out in Title III.
- 1summary of the dossier
- 2Pharmaceutical (physico-chemical, biological or microbiological information (quality))
- 3Safety and residues tests
- 4Pre-clinical and clinical trial
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.