PART 2Amendments to Parts 1 to 5 of the 2013 Regulations

Amendment to regulation 2112

In regulation 21 (records by a holder of a manufacturing authorisation)—

a

for paragraph (1) substitute—

1

The holder of a manufacturing authorisation must record the following information in respect of any veterinary medicinal product supplied by the holder—

a

the name of the veterinary medicinal product and marketing authorisation number if applicable;

b

the pharmaceutical form and strength of the product;

c

the quantity of product supplied;

d

the batch number and expiry date;

e

the date of the transaction under which the product was supplied;

f

the company name and the permanent address or registered place of business of the recipient of the supply.

b

in paragraph (3) at the end insert “or for one year after the date of expiry of the batch, whichever is the longer.”.