- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
16. An application for a wholesale dealer’s authorisation must be made to the Secretary of State.
17. The Secretary of State must process an application for a wholesale dealer’s authorisation within 90 days of receiving it.
18.—(1) The Secretary of State must grant a wholesale dealer’s authorisation on being satisfied that this paragraph is complied with.
(2) The authorised site must be—
(a)weatherproof;
(b)secure and lockable;
(c)clean; and
(d)free from contaminants.
(3) If the veterinary medicinal products covered by the authorisation are subject to specific storage conditions, the site must be capable of fulfilling those requirements.
(4) The authorisation holder must—
(a)have the services of technically competent staff; and
(b)have an effective emergency recall plan.
19.—(1) The wholesale dealer’s authorisation must specify—
(a)the types of veterinary medicinal products and pharmaceutical forms that may be dealt in;
(b)the place where they are to be stored;
(c)the name and address of the person holding the authorisation;
(d)the address of the premises to which it relates;
(e)the name of the qualified person nominated to act under the Guidelines on Good Distribution Practice for Human Use(1).
(2) It may cover more than one site.
(3) It lapses if the holder does not deal in veterinary medicinal products for five years.
(4) The holder of a wholesale dealer’s authorisation must notify the Secretary of State, and if necessary apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation, or in the operations for which they are used, and failure to do so is an offence.
20. The Secretary of State may suspend, vary or revoke a wholesale dealer’s authorisation if the holder—
(a)has not complied with these Regulations; or
(b)no longer has suitable premises or equipment.
21.—(1) The holder of a wholesale dealer’s authorisation must—
(a)store veterinary medicinal products in accordance with the terms of the marketing authorisation for each product;
(b)comply with the Guidelines on Good Distribution Practice of Medicinal Products for Human Use as if the veterinary medicinal products were authorised human medicinal products;
(c)carry out a detailed stock audit at least once a year; and
(d)supply information and samples to the Secretary of State on demand.
(2) It is an offence to fail to comply with this paragraph.
OJ No C 63, 1.3.94, p. 4.
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
Yr Offeryn Cyfan you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Y Rhestrau you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
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:
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