- Deddfwriaeth Ddrafft
This is a draft item of legislation and has not yet been made as a UK Statutory Instrument.
PART 2 Amendment of the Human Medicines Regulations 2012
6.Amendment of regulation 43 (obligations of licence holder)
7.Amendment of regulation 45A (brokering in medicinal products)
8.Amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence)
10.Amendment of regulation 60A (condition as to the submitting of samples and other information to the appropriate authority)
11.Amendment of regulation 60B (submitting of samples and other information: EU marketing authorisations)
12.Amendment of regulation 167 (supply to fulfil special patient needs)
13.Amendment of regulation 182 (obligation on holder to operate pharmacovigilance system)
14.Amendment of regulation 188 (reporting obligations on holders)
15.Amendment of regulation 193 (harmonisation of PSUR frequency or date of submission)
16.Amendment of regulation 199 (submission of draft study protocols for required studies)
17.Amendment of regulation 200 (amendment to study protocols for required studies)
18.Amendment of regulation 201 (submission and evaluation of final study reports for required studies)
19.Amendment of regulation 202A (licensing authority power in relation to medicinal products subject to additional monitoring)
20.Amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation)
PART 3 Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
24.Amendment of regulation 19F (fee for testing of samples by the appropriate authority)
25.Amendment of regulation 27A (fee for renewals of a marketing authorisation)
26.Amendment of regulation 46 (fees for applications for certificates)
27.Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates)
28.Amendment of Schedule 5 (fees for certificates of registration)
PART 4 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
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 Memorandwm Esboniadol Drafft yn nodi datganiad byr o ddiben Offeryn Statudol Drafft ac yn rhoi gwybodaeth am ei amcan polisi a goblygiadau polisi. Eu nod yw gwneud yr Offeryn Statudol Drafft yn hygyrch i ddarllenwyr nad oes ganddynt gymhwyster cyfreithiol, ac maent yn cyd-fynd ag unrhyw Offeryn Statudol neu Offeryn Statudol Drafft a gyflwynwyd yn fanwl gerbron 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:
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