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)
TITLE IREQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
PART 3:SAFETY AND RESIDUES TESTS
A.Safety tests
CHAPTER I:PERFORMANCE OF TESTS
4.Other requirements
4.2.Microbiological properties of residues
4.2.1.Potential effects on the human gut flora
The potential microbiological risk presented by residues of antimicrobial compounds for the human intestinal flora shall be investigated in accordance with established guidance.
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).