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21.—(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;
(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 (manufacturing) 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.
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