# The Veterinary Medicines Regulations 2007, Paragraph 3: Summary of product characteristics


The summary of product characteristics required under the preceding paragraph must include the following information, set out in the same format—
Summary of product characteristics
1
Name of the veterinary medicinal product, followed by its strength and pharmaceutical form.
2
The name and proportion of each active substance, and of any excipient if knowledge of the excipient is needed for safety reasons.
3
Pharmaceutical form.
4
Clinical particulars—
4.1
target species;
4.2
indications for use, specifying the target species;
4.3
contra-indications;
4.4
special warnings for each target species;
4.5
special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals;
4.6
adverse reactions (frequency and seriousness);
4.7
use during pregnancy, lactation or lay;
4.8
interaction with other medicinal products and other forms of interaction;
4.9
amounts to be administered and administration route;
4.10
overdose (symptoms, emergency procedures, antidotes) if necessary;
4.11
withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero.
5
Pharmacological properties—
5.1
pharmacodynamic properties;
5.2
pharmacokinetic particulars.
6
Pharmaceutical particulars—
6.1
list of excipients;
6.2
major incompatibilities;
6.3
shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time;
6.4
special precautions for storage;
6.5
nature and contents of immediate packaging;
6.6
special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate.
7
Marketing authorisation holder.
8
Marketing authorisation number.
9
Date of the first authorisation or date of renewal of the authorisation.
10
Date of any revision of the text.
11
Any other information required by the Secretary of State.

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Source: https://www.legislation.gov.uk/uksi/2007/2539/schedule/1/paragraph/3 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-1/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.