SCHEDULE 2The manufacture of veterinary medicinal products
PART 2Authorisation of manufacturers of autogenous vaccines
Authorisation to manufacture autogenous vaccines15
1
The Secretary of State may authorise a person and premises to manufacture autogenous vaccines for administration in accordance with regulation 15.
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 she authorises the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.
4
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 authorisation16
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.
Labelling17
1
The operator 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;
g
instructions for use, if any.
2
It is an offence to fail to comply with this paragraph.
Records18
1
The operator of premises manufacturing autogenous vaccines 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 reactions19
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.
Inspection of premises20
The Secretary of State shall inspect the authorised premises every two years.