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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) It is an offence to operate an equine stem cell centre other than in accordance with such an authorisation.
31.—(1) Only equine stem cells may be collected.
(2) They may not be collected from embryonic tissues.
(3) The product grown from the collected equine stem cell may only be administered by a veterinary surgeon or under a veterinary surgeon’s responsibility.
(4) It may only be administered to non-food-producing horses.
(5) It is an offence to fail to comply with this paragraph.
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) There must be no specific therapeutic indication on the label or on any information relating to the product.
(3) It is an offence to fail to comply with this paragraph.
33.—(1) 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.
(2) It is an offence to fail to comply with this paragraph.
34. The Secretary of State must inspect the authorised premises every two years.
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