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- Latest available (Revised) - Welsh
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- Original (As made) - Welsh
Mae newidiadau yn dal heb eu gwneud i Rheoliadau Diogelu Iechyd (Coronafeirws, Teithio Rhyngwladol) (Cymru) 2020. Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.
Efallai na fydd deddfwriaeth ddiwygiedig sydd ar y safle hwn yn gwbl gyfoes. Cofnodir newidiadau ac effeithiau gan ein tîm golygyddol mewn rhestrau sydd i'w gweld yn yr adran 'Newidiadau i Ddeddfwriaeth'. Os nad yw'r effeithiau hynny wedi'u cymhwyso eto i destun y ddeddfwriaeth gan y tîm golygyddol maent hefyd wedi'u rhestru ochr yn ochr â'r ddeddfwriaeth yn y darpariaethau yr effeithir arnynt. Defnyddiwch y ddolen 'mwy' i agor y newidiadau a'r effeithiau sy'n berthnasol i'r ddarpariaeth rydych yn edrych arni.
Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):
31.—(1) Person sydd—LL+C
(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.
Gwybodaeth Cychwyn
I1Atod. 2 para. 31 mewn grym ar 8.6.2020 am 12.01 a.m., gweler rhl. 1(2)
O.S. 2004/1031, y ceir diwygiadau iddo nad ydynt yn berthnasol i’r Rheoliadau hyn.
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