- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
1. In this Schedule—
“anthroposophic product” means a medicinal product prepared in accordance with the methods of anthroposophic medicine which is sold or supplied as an anthroposophic product and is so described by the person who sells or supplies that medicinal product;
“derivative”, in relation to a limited use drug or a new active substance, means a medicinal product—
which contains the same active ingredient or combination of active ingredients as that drug or substance but which is either—
a different dosage form of that drug or substance; or
of the same dosage form as, but of a different strength of active ingredient to, or of a different combination of active ingredients to, that drug or substance; and
in respect of which an application for a marketing authorization was made before the determination of the application for the marketing authorization for that drug or substance;
“general sale list medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) of a description or falling within a class specified in an Order made under section 51(1) (general sale lists) of the Act;
“limited use drug” means a medicinal product in respect of which an application for a marketing authorization has been submitted, to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of an orphan medicinal product;
“lower fee” means the periodic fee payable—
where the medicinal product has not been manufactured or imported into the United Kingdom during the period of 12 months preceding the commencement of the relevant fee period; or
in relation to a medicinal product that has been manufactured or imported into the United Kingdom during the period referred to in (a) above, where the value of the product sold or supplied during that period did not exceed £1,000; and
in relation to a prescription only product, where the authorization holder has notified the licensing authority that the medicinal product to which the marketing authorization relates, is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period; or
in relation to a pharmacy medicine or a general sale list medicine, the periodic fee payable during the relevant fee period;
“new active substance” means a medicinal product which is not a limited use drug and which contains an active ingredient which has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has been granted in the five years preceding 31st December in the fee period preceding the relevant fee period;
“pharmacy medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) which is neither a prescription only medicine nor a general sale list medicine;
“prescription only medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy, a homoeopathic product, a new active substance or a derivative of a new active substance) of a description or falling within a class specified in an Order made under section 58(1) (medicinal products on prescription only) of the Act;
“reduced rate fee” means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period does not exceed £35,000;
“standard fee” means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period exceeds £35,000; and
“total value of the product” means the amount calculated in accordance with Part 2 of this Schedule.
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