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8.—(1) In regulation 10(5)(b), after “has undergone any of the treatments referred to in paragraph (3)(a)” there shall be inserted the words “or (b)”.
(2) In regulation 10(5)(c) the word “or” shall be omitted, and at the end of sub–paragraph (d) there shall be added —
“or
(e)does not bear the labelling indications set out in sub–paragraph (c) of paragraph (3) above where required by that sub–paragraph.”.
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