part III Veterinary

A table of contents for the filed application should be provided.

1.1 Pharmacodynamics

Information on the mechanism of action of the active substance(s) shall be provided, together with information on primary and secondary pharmacodynamic effects in order to assist in the understanding of any adverse effects in the animal studies.

1.2 Pharmacokinetics

Data on the fate of the active substance and its metabolites in the species used in the toxicological studies shall be provided.

• Absorption
• Distribution
• Metabolism
• Excretion
• Other Pharmacokinetics Studies (if any)

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


2.2 Repeat Dose Toxicity
Repeat-dose toxicity tests are intended to reveal any physiological and/or pathological changes induced by repeated administration of the active substance or combination of active substances under examination, and to determine how these changes are related to dosage.


2.3 Tolerance in target species of animal - Target animal safety
A summary shall be provided of any signs of intolerance which have been observed during studies conducted, usually with the final formulation, in the target species.


2.4 Reproductive toxicity

2.4.1 Studies of the effects on reproduction
The purpose of this study is to identify possible impairment of male or female reproductive function or harmful effects on progeny resulting from the administration of the veterinary medicinal products or substance under investigation.

2.4.2 Embryotoxicity/ foetotoxicity, including teratogenicity
For use in food-producing animals, tests on developmental toxicity shall be performed.
For non- food producing animals, a study of developmental toxicity shall be performed in at least one species, which may be the target species, if the product is intended for use in female animals which may be used for breeding.

2.5 Mutagenicity
Tests to reveal changes which a substance may cause in the genetic material of cells.


2.6 Carcinogenicity (if necessary)
Where carcinogenicity testing is necessary, generally a two-year rat study and an 18-month mouse study are required

3.1 Special studies (e.g. neurotoxicity, sensitisation etc.)
3.2 Microbiological studies
3.3 Studies on metabolites, impurities, other substances & formulation
3.4  Observations in human
Information shall be provided showing whether the pharmacologically active substances of the veterinary medicinal product are used as medicinal products in human therapy.

4.1 Inherent toxicity or other harmful effects

4.2 Route and degree of exposure

4.3 Risk management proposal

Discussion of the effects found in the preceding sections and relate this to the type and extent of human exposure to the product with a view to formulating appropriate user warnings and other risk management measures.

5.1 Extent of exposure of the product to the environment


5.2 Specific investigations of the following, as appropriate:- fate and degradation in soil, fate and behaviour in water and air, effects on aquatic organisms, effects on other non-target organisms

• List of referenced documents, including important published articles, official meeting minutes or other regulatory guidance or advice
• Includes all references cited in the non-clinical documentations

• A detailed identification of the product used in the testing and conditions of use relevant to residue studies.
• Should include the following: formulation, detailing active ingredients and excipients that may affect the residue profile

2.1 Pharmacokinetics

2.2 Depletion of residues

The purpose of these studies, which measure the rate at which residues deplete in the target animal after the last administration of the medicinal product, is to permit the determination of withdrawal periods.

2.3 MRLs

2.4 Withdrawal periods

3.1 Description of the method

3.2 Validation of the method

      3.2.1 Specificity

      3.2.2 Accuracy, including sensitivity

      3.2.3 Precision

      3.2.4 Limit of detection

      3.2.5 Limit of quantification

      3.2.6 Practicability and applicability under normal laboratory conditions

      3.2.7 Susceptibility to interference

      3.2.8 Stability of incurred residues