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This is the original version (as it was originally made).
31.—(1) Person sydd—
(a)wedi teithio i’r Deyrnas Unedig—
(i)i gynnal treial clinigol o fewn ystyr “conducting a clinical trial” yn rheoliad 2(1) o Reoliadau Meddyginiaethau i’w Defnyddio gan Bobl (Treialon Clinigol) 2004(1),
(ii)i ymgymryd ag unrhyw weithgareddau sy’n angenrheidiol neu’n hwylus i baratoi at gynnal treial clinigol, neu
(iii)i gyflawni unrhyw weithgarwch cydymffurfio angenrheidiol mewn perthynas â threial clinigol na ellir ei gynnal o bell,
(b)yn berson cymwys yn yr ystyr a roddir i “qualified person” yn rheoliad 43 o’r Rheoliadau hynny, pan fo wedi teithio i’r Deyrnas Unedig er mwyn ymgymryd â gweithgareddau mewn perthynas â’i rôl fel person o’r fath, neu
(c)yn noddwr yn yr ystyr a roddir i “sponsor” yn rheoliad 2(1) o’r Rheoliadau hynny, neu’n cyflawni swyddogaethau neu ddyletswyddau noddwr, treial clinigol ac wedi teithio i’r Deyrnas Unedig i ymgymryd â gweithgareddau mewn perthynas â’r treial clinigol.
(2) At ddibenion is-baragraff (1), mae i “treial clinigol” yr ystyr a roddir i “clinical trial” yn rheoliad 2(1) o Reoliadau Meddyginiaethau i’w Defnyddio gan Bobl (Treialon Clinigol) 2004.
O.S. 2004/1031, y ceir diwygiadau iddo nad ydynt yn berthnasol i’r Rheoliadau hyn.
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