Paragraph 3 Summary of product characteristicsI1

United Kingdom

The summary of product characteristics required under the preceding paragraph shall include the following information, set out in the same format—

Summary of product characteristics
1	Name of the veterinary medicinal product, including 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.

Annotations

Commencement

I1: Sch. 1 para. 3 in force at 1.10.2006, see reg. 1