SCHEDULE 2The manufacture of veterinary medicinal products
F1PART 2AActive Substances
F1Inspection of sitesE130
The Secretary of State may, from time to time, inspect sites registered under paragraph 26, basing the frequency of the inspections on the risks associated with each site’s history and the nature of the substances handled at the site.
Authorisation of stem cell centresE230
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.
Sch. 2 Pts. 2A (paras. 26-31), 2B (para. 32) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 93