SCHEDULE 5Medicated feedingstuffs and specified feed additives

Labelling of feedingstuffs containing a F1medicinal premixE114

1

Feedingstuffs containing a F2medicinal premix must be clearly and legibly labelled with the following—

a

the words “MEDICATED COMPLETE FEED” in upper case letters, or where feedingstuffs are to be labelled as a complementary feedingstuff and intended to be fed to animals without further mixing with feed materials, the words “MEDICATED COMPLEMENTARY FEEDINGSTUFF”;

b

the proprietary name, authorisation number and inclusion rate (kg/tonne or mg/kg) of the F2medicinal premix incorporated into the feedingstuffs;

c

the name and amount of the active substance (mg/kg) in the feedingstuffs;

d

the species of animal for which the feedingstuffs are intended;

e

warnings and contra-indications;

F3ea

the contact details (including a free helpline number) for the supplier of the product;

eb

the words “inappropriate disposal of this product poses a serious threat to the environment”;

ec

in the case of a product containing an antibiotic, the words “inappropriate disposal of this product may contribute to antimicrobial resistance”;

f

the withdrawal period, and a statement that, if the F5medicated feedingstuffs prescription requires a longer withdrawal period, that is the one that applies;

F4fa

the batch number;

g

the expiry date;

h

any special storage instructions required by the marketing authorisation;

i

a statement to the effect that the feedingstuffs must only be fed in accordance with its F6medicated feedingstuffs prescription;

j

the name and F7authorisation number of the manufacturer or the distributor.

2

If there is more than one F8medicinal premix used, the longest withdrawal period must be shown on the label.

3

If the feedingstuff also contains a specified feed additive to which this Schedule applies it must also contain the information required by Articles 15 and 17 of Regulation (EC) No 767/2009 of the European Parliament and of the Council.

4

No person may supply feedingstuffs F9containing a medicinal premix unless they are labelled in accordance with this paragraph.

Labelling of feedingstuffs containing a veterinary medicinal productE214

1

Feedingstuffs containing a veterinary medicinal product must be clearly and legibly labelled with the following—

a

the words “MEDICATED COMPLETE FEED” in upper case letters, or where feedingstuffs are to be labelled as a complementary feedingstuff and intended to be fed to animals without further mixing with feed materials, the words “MEDICATED COMPLEMENTARY FEEDINGSTUFF”;

b

the proprietary name, authorisation number and inclusion rate (kg/tonne or mg/kg) of the veterinary medicinal product incorporated into the feedingstuffs;

c

the name and amount of the active substance (mg/kg) in the feedingstuffs;

d

the species of animal for which the feedingstuffs are intended;

e

warnings and contra-indications;

f

the withdrawal period, and a statement that, if the prescription requires a longer withdrawal period, that is the one that applies;

g

the expiry date;

h

any special storage instructions required by the marketing authorisation;

i

a statement to the effect that the feedingstuffs must only be fed in accordance with its prescription;

j

the name and approval number of the manufacturer or the distributor.

2

If there is more than one veterinary medicinal product used, the longest withdrawal period must be shown on the label.

3

If the feedingstuff also contains a specified feed additive to which this Schedule applies it must also contain the information required by Articles 15 and 17 of Regulation (EC) No 767/2009 of the European Parliament and of the Council.

4

No person may supply feedingstuffs unless they are labelled in accordance with this paragraph.