Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (c. 82)

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[F1 ANNEX I U.K. CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS

Textual Amendments

F1 Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance).

TITLE I U.K. REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS U.K.

PART 3: U.K. SAFETY AND RESIDUES TESTS

A. Safety tests U.K.

CHAPTER I: U.K. PERFORMANCE OF TESTS

3. Toxicology U.K.

3.1. Single-dose toxicity U.K.

Single-dose toxicity studies may be used to predict:

• the possible effects of acute overdosage in the target species,

• the possible effects of accidental administration to humans,

• the doses which may usefully be employed in the repeat dose studies.

Single-dose toxicity studies should reveal the acute toxic effects of the substance and the time course for their onset and remission.

The studies to be carried out shall be selected with a view to providing information on user safety, e.g. if substantial exposure by inhalation or dermal contact of the user of the veterinary medicinal product is anticipated, those routes of exposure shall be studied.]