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4. The parts of the approved dossier referred to in the preceding paragraph are:
(a) the maximum number of animals included in the test, where this is to be increased,
(b) the arrangements for disposal of treated animals, if the new arrangements involve the commencement of, or an increase in, animals or animal products being sent for human consumption,
(c) the approved withdrawal period,
(d) the dosage for the product, and its duration, and the frequency of administration, where any of these are to be increased, and
(e) the product’s labelling, leaflet or package insert, where changes are required consequent on the alterations referred to in the preceding sub-paragraphs.
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