F1ANNEX ICHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS
Annotations:
Amendments (Textual)
INTRODUCTION AND GENERAL PRINCIPLES
2.
In assembling the dossier for application for marketing authorisation, applicants shall also take into account the current state of veterinary medicinal knowledge and the scientific guidelines relating to the quality, safety and efficacy of veterinary medicinal products published by the European Medicines Agency (Agency) and the other pharmaceutical Community guidelines published by the Commission in different volumes of The rules governing medicinal products in the European Union.
Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance).