The Veterinary Medicines Regulations 2013

PART 2 U.K. Authorisation of manufacturers of autogenous vaccines

Authorisation to manufacture autogenous vaccines U.K.

14.—(1) The Secretary of State may authorise a person to manufacture autogenous vaccines and may authorise premises for the purpose of such manufacture by that person.

(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 authorising the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.

(4) No person may manufacture an autogenous vaccine other than in accordance with an authorisation under sub-paragraph (1).

Types of authorisation U.K.

15.—(1) The authorisation must specify the products that may be manufactured.

(2) It may either be for the production of a single batch of product or for ongoing production of the products specified in the authorisation.

(3) If it is for a single batch it must 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.

Labelling U.K.

16.  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.

Records U.K.

17.  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 identification of the source animal;

(c) the expiry date;

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

and must keep the records for at least five years.

Adverse reactions U.K.

18.  The authorised person must notify the Secretary of State of any adverse reactions to an autogenous vaccine within 15 days of learning of the reaction.

Inspection of premises U.K.

19.  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.