Chwilio Deddfwriaeth

Chwiliad Uwch

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

Help about what version

Pa Fersiwn

Help about opening options

Dewisiadau Agor

Changes to legislation:

There are currently no known outstanding effects for the The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

  1. Introductory Text

  2. 1.Citation and commencement

  3. 2.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

  4. 3.Amendment of regulation 2 (interpretation)

  5. 4.Insertion of regulation 2A (list of countries for the purpose of the definition of “marketing authorization”)

  6. 5.Amendment of regulation 3 (sponsor of a clinical trial)

  7. 6.Omission of regulation 4 (responsibility for functions under the Directive)

  8. 7.Amendment of regulation 13 (supply of investigational medicinal products for the purpose of clinical trials)

  9. 8.Amendment of regulation 15 (ethics committee opinion)

  10. 9.Amendment of regulation 20 (authorisation procedure for clinical trials involving medicinal products with special characteristics)

  11. 10.Amendment of regulation 21 (clinical trials conducted in third countries)

  12. 11.Insertion of regulation 27B (publication of information)

  13. 12.Amendment of regulation 31 (suspension or termination of clinical trial)

  14. 13.Amendment of regulation 31A (trial master file and archiving)

  15. 14.Amendment of regulation 33 (notification of suspected unexpected serious adverse reactions)

  16. 15.Amendment of regulation 34 (clinical trials conducted in third countries)

  17. 16.Amendment of regulation 35 (annual list of suspected serious adverse reactions and safety report)

  18. 17.Amendment of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products)

  19. 18.Amendment of regulation 43 (qualified persons)

  20. 19.Insertion of regulation 43A (approved country for import)

  21. 20.Amendment of regulation 45 (suspension and revocation of manufacturing authorisation)

  22. 21.Amendment of regulation 48 (infringement notices)

  23. 22.Amendment of regulation 56 (transitional provisions)

  24. 23.Insertion of regulation 57 (functions in relation to good clinical practice)

  25. 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)

  26. 25.Amendment of Schedule 7 (standard provisions for manufacturing authorisations)

  27. 26.Insertion of Schedule 13 (transitional provisions in relation to EU Exit)

  28. Signature

  29. Explanatory Note

Yn ôl i’r brig

Options/Help

Print Options

Close

Mae deddfwriaeth ar gael mewn fersiynau gwahanol:

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.

Close

Dewisiadau Agor

Dewisiadau gwahanol i agor deddfwriaeth er mwyn gweld rhagor o gynnwys ar y sgrin ar yr un pryd

Close

Memorandwm Esboniadol

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.

Close

Rhagor o Adnoddau

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:

  • y PDF print gwreiddiol y fel deddfwyd fersiwn a ddefnyddiwyd am y copi print
  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • manylion rhoi grym a newid cyffredinol
  • pob fformat o’r holl ddogfennau cysylltiedig
  • slipiau cywiro
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill
Close

Asesiadau Effaith

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:

  • Why the government is proposing to intervene;
  • The main options the government is considering, and which one is preferred;
  • How and to what extent new policies may impact on them; and,
  • The estimated costs and benefits of proposed measures.
Close

Llinell Amser Newidiadau

This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.

Close

Rhagor o Adnoddau

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:

  • y PDF print gwreiddiol y fel gwnaed fersiwn a ddefnyddiwyd am y copi print
  • slipiau cywiro

liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys

  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • manylion rhoi grym a newid cyffredinol
  • pob fformat o’r holl ddogfennau cysylltiedig
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill