- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
2.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
4.Insertion of regulation 2A (list of countries for the purpose of the definition of “marketing authorization”)
6.Omission of regulation 4 (responsibility for functions under the Directive)
7.Amendment of regulation 13 (supply of investigational medicinal products for the purpose of clinical trials)
9.Amendment of regulation 20 (authorisation procedure for clinical trials involving medicinal products with special characteristics)
10.Amendment of regulation 21 (clinical trials conducted in third countries)
12.Amendment of regulation 31 (suspension or termination of clinical trial)
13.Amendment of regulation 31A (trial master file and archiving)
14.Amendment of regulation 33 (notification of suspected unexpected serious adverse reactions)
15.Amendment of regulation 34 (clinical trials conducted in third countries)
16.Amendment of regulation 35 (annual list of suspected serious adverse reactions and safety report)
17.Amendment of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products)
19.Insertion of regulation 43A (approved country for import)
20.Amendment of regulation 45 (suspension and revocation of manufacturing authorisation)
23.Insertion of regulation 57 (functions in relation to good clinical practice)
24.Amendment of Schedule 3 (particulars and documents that must accompany an application for an ethics committee opinion, a request for authorisation, a notice of amendment and a notification of the conclusion of a trial)
25.Amendment of Schedule 7 (standard provisions for manufacturing authorisations)
26.Insertion of Schedule 13 (transitional provisions in relation to EU Exit)
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.
Mae Memoranda Esboniadol yn nodi datganiad byr o ddiben Offeryn Statudol ac yn rhoi gwybodaeth am ei amcan polisi a goblygiadau polisi. Maent yn ceisio gwneud yr Offeryn Statudol yn hygyrch i ddarllenwyr nad oes ganddynt gymhwyster cyfreithiol, ac maent yn cyd-fynd ag unrhyw Offeryn Statudol neu Offeryn Statudol Drafft a gyflwynwyd ger bron y Senedd o Fehefin 2004 ymlaen.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys