SCHEDULE 2THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS
PART 2Authorisation of manufacturers of autogenous vaccines
Authorisation to manufacture autogenous vaccinesI515
1
The Secretary of State may authorise a person and premises to manufacture autogenous vaccines.
2
In order to be authorised the premises must be under the supervision of—
a
a veterinary surgeon, or
b
a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.
3
Before he authorises the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.
4
The procedure for the suspension or revocation of the authorisation is the same as for the holder of a manufacturing authorisation.
5
It is an offence to manufacture an autogenous vaccine other than in accordance with such an authorisation.
Types of authorisationI316
1
The authorisation shall specify the products that may be manufactured.
2
It shall either be for the production of a single batch of product or for on-going production of the products specified in the authorisation.
3
If it is for a single batch the authorisation shall be time-limited.
4
Only the products specified in the authorisation may be manufactured, and in the case of an authorisation for a single batch the product may only be manufactured before the expiry of the authorisation.
LabellingI617
1
The operator of the premises must ensure that every container containing autogenous vaccine is labelled with—
a
the name of the veterinary surgeon who ordered the vaccine;
b
a precise description of the vaccine;
c
the date the vaccine was produced;
d
the name of the authorisation holder and address of the authorised premises;
e
the expiry date;
f
any necessary warnings; and
g
instructions for use.
2
It is an offence to fail to comply with this paragraph.
RecordsI418
1
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 identity of the source animal;
c
the expiry date;
d
the date of supply to the veterinary surgeon.
2
He must keep the records for at least five years.
3
It is an offence to fail to comply with this paragraph.
Adverse reactionsI219
1
The authorised person must notify the Secretary of State of any adverse reactions to an autogenous vaccine of which he becomes aware within 15 days of learning of the reaction.
2
It is an offence to fail to comply with this paragraph.
Inspection of premisesI120
The Secretary of State shall inspect the authorised premises every two years.