SCHEDULE 2The manufacture of veterinary medicinal products
F1PART 2Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade
F1Process of authorisationE117
1
An applicant for authorisation under paragraph 14 must, at least two months before commencing an activity mentioned in that paragraph, submit the following to the Secretary of State—
a
the name and address of the proposed holder of the authorisation;
b
a description of the activity in which the applicant for authorisation proposes to be engaged;
c
particulars (including the name and address) in relation to the site at which the relevant activity is to be carried out (whether in the occupation of the proposed holder or otherwise) and a description of the technical equipment on the site;
d
particulars in relation to the qualifications and experience of the proposed PRR who will supervise the activities at the site.
2
The application must include a declaration that the applicant will comply with the requirements of these Regulations and confirmation that the site is ready for inspection.
3
Before granting an authorisation in relation to a site, the Secretary of State must be satisfied that the production process carried out there will produce a consistent, safe product and, in the case of a blood bank or a stem cell centre, that the welfare of the animals involved in the processes will be respected.
RecordsE217
The operator of the premises must, as soon as is reasonably practicable, record—
a
the name and address of the veterinary surgeon who ordered the vaccine;
b
the identification of the source animal;
c
the expiry date;
d
the date of supply to the veterinary surgeon,
and must keep the records for at least five years.
Sch. 2 Pt. 2 (paras. 14-25 entitled "Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade") substituted for Sch. 2 Pt. 2 (paras. 14-19 entitled "Authorisation of manufacturers of autogenous vaccines"), Pt. 3 (paras. 20-24 entitled "Authorisation of blood banks"), Pt. 4 (paras. 25-29 entitled "Authorisation of manufacturers of products for administration under the cascade") and Pt. 5 (paras. 30-35 entitled "Authorisation of equine stem cell centres") (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 92