PART 3Records
Records by a holder of a manufacturing authorisation21
1
A holder of a manufacturing authorisation must, as soon as is reasonably practicable, make a record of each batch of veterinary medicinal product manufactured, assembled or supplied by him, which must include—
a
the name of the product;
b
the quantity manufactured, assembled or supplied;
c
the date of manufacture, assembly or supply;
d
the batch number and expiry date; and
e
in the case of supply, the name and address of the recipient.
2
He must keep with the record all certification provided by the qualified person (manufacture) in relation to that batch.
3
He must keep all records and certificates for at least five years from the date the veterinary medicinal product is placed on the market.
4
It is an offence to fail to comply with this regulation.