- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
16. After regulation 18, insert—
18A.—(1) The licensing authority must—
(a)publish a list of countries from which medicinal products may be imported under a wholesale dealing licence (“approved country for import list”); and
(b)only include in that list a country which is included in the approved country for batch testing list.
(2) In order to determine whether a country should be included in the approved country for import list, the licensing authority may, in particular, take into account—
(a)the country’s system for ensuring that each batch of a medicinal product has been manufactured and checked in accordance with the requirements of its legislation and any authorisation in respect of that product;
(b)the country’s rules for good distribution practice;
(c)the regularity of inspections to verify compliance with good distribution practice;
(d)the effectiveness of enforcement of good distribution practice;
(e)the regularity and rapidity of information provided by that country relating to non-compliant manufacturers and distributers of medicinal products;
(f)any on-site review of that country’s regulatory system undertaken by the licensing authority;
(g)any on-site inspection of a manufacturing site in that country observed by the licensing authority; and
(h)any other relevant documentation available to the licensing authority.
(3) The licensing authority must—
(a)remove a country from the approved country for import list if that country is removed from the approved country for batch testing list;
(b)in any event review the countries it has included in the approved country for import list to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; and
(c)undertake that review at least every three years beginning with the date on which that country is included in that list.”.
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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