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6. The parts of the approved dossier referred to in the preceding paragraph are:
(a) any of the particulars referred to in paragraphs 1, 2, 3 or 9(a), (c), (d), (g) or (h) of Part I of Schedule 1,
(b) the species of animal included in the test,
(c) any of the particulars referred to in Part II of Schedule 1 where the proposed alteration will affect the product’s bioavailability or stability, or the range or level of impurities it contains, and
(d) the product’s labelling, leaflet or package insert, where changes are required other than as referred to in paragraph 4(e) above.
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