- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
5.—(1) In these Regulations references to a medicinal product subject to general sale are to a product that is not a prescription only medicine or a pharmacy medicine but is—
(a)a product that is covered by an authorisation of which it is a term that the product is to be available on general sale; or
(b)a product that—
(i)is covered by an EU marketing authorisation, and
(ii)is not classified in the authorisation as a prescription only medicine, and
(iii)the licensing authority has determined should be available on general sale.
(2) In paragraphs (1)(a) and (5)(a) “authorisation” means—
(a)a UK marketing authorisation;
(b)a certificate of registration;
(c)a traditional herbal registration; or
(d)an Article 126a authorisation.
(3) In these Regulations references to a prescription only medicine are to any of the following—
(a)a medicinal product that is covered by an authorisation of which it is a term that the product is to be available only on prescription;
(b)a medicinal product that—
(i)is covered by an EU marketing authorisation, and
(ii)is classified in the authorisation as a prescription only medicine;
(c)a medicinal product that is a prescription only medicine by virtue of Part 1 of Schedule 1; or
(d)a medicinal product that is the result of—
(i)the assembly, or
(ii)the reformulation (including the combining with other substances),
of a medicinal product that is a prescription only medicine by virtue of sub-paragraph (a) or (b).
(4) In paragraph (3)(a) “authorisation” means—
(a)a UK marketing authorisation; or
(b)an Article 126a authorisation.
(5) In these Regulations references to a pharmacy medicine are to a medicinal product that is not a prescription only medicinal product or a medicinal product subject to general sale but is—
(a)covered by an authorisation of which it is a term that the product is to be available only from a pharmacy;
(b)a product that—
(i)is covered by an EU marketing authorisation, and
(ii)is not classified in the authorisation as a prescription only medicine,
other than a product to which paragraph (1)(b)(iii) applies;
(c)available only from a pharmacy by virtue of Part 2 of Schedule 1; or
(d)the result of—
(i)the assembly, or
(ii)the reformulation (including the combining with other substances),
of a medicinal product that is a pharmacy medicine by virtue of sub-paragraph (a) or (b).
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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