The Veterinary Medicines Regulations 2009 (revoked)

PART 4 U.K. Authorisation of manufacturers of products for administration under the cascade

Authorisation to manufacture products for administration under the cascade U.K.

25.—(1) The Secretary of State may authorise a person and premises to manufacture an unauthorised veterinary medicinal product for administration under the cascade.

(2) In order to be authorised the premises must be under the supervision of a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.

(3) Before authorising the premises, the Secretary of State must be satisfied that the production process will produce a 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) The authorisation must specify what types of product it covers.

(6) It is an offence for the holder of an authorisation to manufacture a product other than in accordance with the authorisation.

Labelling U.K.

26.—(1) The authorised person must ensure that, before a veterinary medicinal product is supplied, every container is labelled with—

(a) the name of the veterinary surgeon who ordered the veterinary medicinal product;

(b) a precise description of the veterinary medicinal product;

(c) the date of production;

(d) the name of the authorisation holder and the 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.

Records U.K.

27.—(1) The authorised person must, as soon as is reasonably practicable, record—

(a) the name and address of the veterinary surgeon who ordered the veterinary medicinal product;

(b) a precise description of the veterinary medicinal product;

(c) the date of production;

(d) the expiry date; and

(e) the date of supply to the veterinary surgeon,

and must keep the record for at least five years.

(2) It is an offence to fail to comply with this paragraph.

Adverse reactions U.K.

28.—(1) The authorised person must notify the Secretary of State of any adverse reactions to a product manufactured by that person within 15 days of learning of the reaction.

(2) It is an offence to fail to comply with this paragraph.

Inspection of premises U.K.

29.  The Secretary of State must inspect the authorised premises, basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.