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 IIREQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
PART 2:CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL/MICROBIOLOGICAL INFORMATION (QUALITY)
E.CONTROL TESTS ON THE FINISHED PRODUCT
6.Safety tests
Apart from the results of tests submitted in accordance with Part 3 of this Title (Safety Tests), particulars of the batch safety tests shall be submitted. These tests shall preferably be overdosage studies carried out in at least one of the most sensitive target species and by at least the recommended route of administration posing the greatest risk. Routine application of the batch safety test may be waived in the interests of animal welfare when a sufficient number of consecutive production batches have been produced and been found to comply with the test.
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).