SCHEDULE 6Exemptions for small pet animals
Animals to which this Schedule applies1
This Schedule applies in relation to veterinary medicinal products intended solely for the following animals kept exclusively as a pet—
a
aquarium animals;
b
cage birds;
c
ferrets;
d
homing pigeons;
e
rabbits;
f
small rodents; and
g
terrarium animals.
Placing on the market, importing and administering the product2
A veterinary medicinal product intended solely for an animal to which this Schedule applies may be placed on the market, imported or administered without a marketing authorisation if it complies with this Schedule.
Manufacture3
The product must have been manufactured by—
a
the holder of a manufacturing authorisation if manufactured in the United Kingdom;
b
the holder of a manufacturing authorisation issued under Directive 2001/82/EC if manufactured in another member State;
c
in the case of Australia, Canada, New Zealand, or Switzerland, the holder of an authorisation from the competent authority permitting the manufacture of medicinal products;
d
in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.
Approval of the active substance4
1
The Secretary of State may approve an active substance for use in a veterinary medicinal product manufactured under this Schedule.
2
The Secretary of State may not grant an approval if the active substance requires veterinary control.
3
The approval must specify the species of animals for which it is approved, and may specify how the active substance or a product containing it is to be administered.
4
The Secretary of State may suspend or revoke the approval (or limit it to a smaller number of species) if—
a
it is demonstrated that the substance requires veterinary control;
b
serious adverse reactions are reported making suspension or revocation necessary; or
c
it is demonstrated that the substance—
i
is carcinogenic;
ii
is genotoxic; or
iii
shows developmental toxicity (including teratogenicity).
5
The procedure for the refusal, suspension or revocation of an approval under this paragraph is the same as the procedure for a marketing authorisation.
The product5
1
The active substance in the veterinary medicinal product must be approved under paragraph 4.
2
The veterinary medicinal product must not be an antibiotic.
3
It must not contain any narcotic or psychotropic substance.
4
It must not be intended for treatments or pathological processes that require a precise prior diagnosis or the use of which may cause effects that impede or interfere with subsequent diagnostic or therapeutic measures.
Labelling6
1
The product must be clearly labelled as being exempt from the requirements of these Regulations in relation to a marketing authorisation.
2
The labelling must show the following—
a
the name of the veterinary product, including, if it is part of the name, its strength and pharmaceutical form;
b
the authorisation number of the manufacturer;
c
the name and strength of each active substance;
d
the route of administration;
e
the batch number;
f
the expiry date;
g
the words “For animal treatment only”;
h
the contents by weight, volume or number of dose units;
i
the name and address of the manufacturer or distributor;
j
the target species;
k
the words “Keep out of reach of children”;
l
storage instructions;
m
the shelf-life after the immediate packaging has been opened for the first time;
n
disposal advice;
o
full indications, including—
i
therapeutic indications;
ii
contra-indications;
iii
interaction with other medicines and other forms of interaction; and
p
dosage instructions.
3
If there is insufficient room on the label, the information may instead be in a package leaflet, but the leaflet must contain all the information in the preceding sub-paragraph other than the batch number and the expiry date, but the label on the product must contain at least the following—
a
the name of the veterinary medicinal product;
b
its active substance and its strength;
c
the route of administration;
d
the batch number;
e
the expiry date; and
f
the words “For animal treatment only”.
Administration7
The method of administration must be oral or topical or (in the case of a product for fish) by addition to the water.
Pack size8
The pack size must only be sufficient for a single course of treatment or, in the case of a veterinary medicinal product for aquarium fish, sufficient for a single course of treatment of no more than 7 administrations to an aquarium of 25,000 litres.
Adverse reactions9
1
The manufacturer, importer or retailer of a veterinary medicinal product must—
a
notify the Secretary of State within 15 days of learning of any serious adverse reactions (as defined in paragraph 57 of Schedule 1); and
b
make a record of each adverse reaction and serious adverse reaction on becoming aware of it and keep it for three years.
2
It is an offence to fail to comply with this paragraph.