SCHEDULE 1Marketing authorisations F1in Great BritainF2in Northern Ireland
Words in Sch. 1 heading inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(a)
PART 7Labelling and package leaflets
F3Labelling of immediate packaging of veterinary medicinal productsE148
1
Subject to paragraph 50, the following information must be provided on the immediate packaging of a veterinary medicinal product—
a
the name of the product, followed by its strength and pharmaceutical form;
b
a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;
c
the batch number, preceded by the word “Lot”;
d
the name or company name or logo of the marketing authorisation holder;
e
the target species;
f
the expiry date, in the format ‘mm/yyyy’, preceded by the abbreviation “Exp.”;
g
special storage precautions, if any;
h
the route of administration;
i
if applicable, the withdrawal period, even if such period is zero.
2
Where there is no outer packaging for the product, the information set out in paragraph 49 must be included on the immediate packaging of the veterinary medicinal product.
3
The information referred to in paragraph (1) must appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms.
Labelling with all the information on the immediate packagingE248
1
If it is reasonably practicable to do so, the following must be provided on the immediate packaging, in legible characters—
a
the name, strength and pharmaceutical form of the veterinary medicinal product;
b
the name and strength of each active substance, and of any excipient if this is required under paragraph 2 of the summary of product characteristics;
c
the route of administration (if not immediately apparent);
d
the batch number;
e
the expiry date;
f
the words “For animal treatment only” and, if appropriate, “To be supplied only on veterinary prescription”;
g
the contents by weight, volume or number of dose units;
h
the marketing authorisation number;
i
the name and address of the marketing authorisation holder or, if there is a distributor authorised in the marketing authorisation, that distributor;
j
a suitably labelled space to record discard date (if relevant);
k
the target species;
l
the distribution category;
m
the words “Keep out of reach of children”;
n
storage instructions;
o
the in-use shelf-life (if appropriate);
p
for food-producing species, the withdrawal period for each species or animal product concerned;
q
any warning specified in the marketing authorisation;
r
disposal advice;
s
full indications;
t
dosage instructions;
u
contra-indications;
v
further information required in the marketing authorisation;
w
if the product is one that requires a dose to be specified for the animal being treated, a space for this.
2
If all this is on the immediate packaging, there is no need for any outer packaging or a package leaflet.
Words in Sch. 1 heading inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(7)(a)