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.