SCHEDULE 1MARKETING AUTHORISATIONS

PART 7Labelling and package leaflets

Homeopathic remediesI152

1

A homeopathic remedy registered under these Regulations must be labelled in accordance with this paragraph.

2

There must be no specific therapeutic indication on the labelling or in any information relating to it.

3

The labelling (or labelling and package leaflet) must contain the following and no other information—

a

the words “homeopathic remedy without approved therapeutic indications for veterinary use”;

b

the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used (if the homeopathic remedy is composed of more than one stock, the labelling may mention an invented name in addition to the scientific names of the stocks);

c

the name and address of the registration holder and (on the package leaflet) of the manufacturer;

d

the method and, if necessary, route of administration;

e

the expiry date;

f

the pharmaceutical form;

g

the contents of the pack;

h

any special storage precautions;

i

the target species;

j

any necessary special warnings;

k

the batch number; and

l

the registration number.