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

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)

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.

• 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