- Latest available (Revised)
- Point in Time (01/10/2013)
- Original (As made)
Point in time view as at 01/10/2013.
There are outstanding changes not yet made by the legislation.gov.uk editorial team to The Veterinary Medicines Regulations 2013. Any changes that have already been made by the team appear in the content and are referenced with annotations.
Changes and effects yet to be applied by the editorial team are only applicable when viewing the latest version or prospective version of legislation. They are therefore not accessible when viewing legislation as at a specific point in time. To view the ‘Changes to Legislation’ information for this provision return to the latest version view using the options provided in the ‘What Version’ box above.
30.—(1) The Secretary of State may authorise equine stem cell centres for the collection, storage, processing, production and administration of equine stem cells for use as an autologous treatment for horses.
(2) In order to be authorised a centre must be under the supervision of—
(a)a veterinary surgeon named in the authorisation; or
(b)a person named in the authorisation who the Secretary of State is satisfied is suitably qualified to operate the centre.
(3) Before authorising a centre, the Secretary of State must be satisfied—
(a)that the welfare of animals used in the collection of equine stem cells will be respected; and
(b)that the production process will produce a consistent, safe product.
(4) Equine stem cells may only be collected under the responsibility of a veterinary surgeon.
(5) The Secretary of State may suspend, vary or revoke an authorisation of an equine stem cell centre if—
(a)the holder no longer uses fit and proper processes;
(b)the premises in which the centre is being or is to be operated are not suitable;
(c)the equipment of the centre is not suitable; or
(d)the holder has not complied with these Regulations.
(6) No person may operate an equine stem cell centre other than in accordance with such an authorisation.
31.—(1) The operator of an equine stem cell centre may only collect equine stem cells.
(2) The operator of an equine stem cell centre may not collect stem cells from embryonic tissues.
(3) No person other than a veterinary surgeon or someone acting under a veterinary surgeon’s responsibility may administer any product grown from collected equine stem cells.
(4) No person may administer any product grown from collected equine stem cells to a food-producing horse.
32.—(1) The operator of an equine stem cell centre must ensure that every container used for the stem cell product is labelled with—
(a)the identification of the donor animal;
(b)the date of collection;
(c)the authorisation number of the equine stem cell centre;
(d)any necessary warnings;
(e)the expiry date.
(2) The operator of an equine stem cell centre must ensure that no specific therapeutic indication is included on the label or on any information relating to the product.
33. The operator of an equine stem cell centre must, as soon as is reasonably practicable, record for each stem cell product—
(a)the identification of the donor animal;
(b)the date of collection;
(c)the veterinary surgeon under whose responsibility the stem cells were collected;
(d)the expiry date;
(e)the date the product was used or, if it was supplied to another veterinary surgeon, the name of that veterinary surgeon and the date it was supplied,
and must keep the records for at least five years.
34. The Secretary of State must inspect the authorised premises, basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.
35. It is an offence to fail to comply with—
(a)paragraph 4(3);
(b)paragraph 11;
(c)paragraph 14(4);
(d)paragraph 16;
(e)paragraph 17;
(f)paragraph 18;
(g)paragraph 20(6) or (7);
(h)paragraph 21;
(i)paragraph 22;
(j)paragraph 23;
(k)paragraph 25(5);
(l)paragraph 26;
(m)paragraph 27;
(n)paragraph 28;
(o)paragraph 30(4) or (6);
(p)paragraph 31;
(q)paragraph 32; or
(r)paragraph 33.
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?
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 Schedules 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?
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
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:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: