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

This section should address:


Pharmacokinetics

• The kinetic profile of the final formulation when administered at relevant doses to the target animal species.
• The possible pharmacokinetic interactions with other drugs.
• The overall conclusion on the pharmacology section, indicating the main strengths and weaknesses of the scientific data and arguments presented. If there are remain outstanding concerns, these should also be indicated.

 
Pharmacodynamics

• The mode of action of the active substance, if it is known.
• In case of antibacterial or antiparasitic products, the outline on how the active substance acts on target pathogens.
• In case of a fixed combination product the statement on how the active substances interact.

• The local and systemic tolerance of the product shall be investigated in the target animal species. The purpose of these studies is to characterise signs of intolerance and to establish an adequate margin of safety using the recommended route(s) of administration.
• The report on the trials shall contain details of all expected pharmacological effects and all adverse reactions.
• The local tolerance should be assessed for parenteral formulations, intramammary products, and formulations for external use.

• This section applies to antimicrobial and antiparasitic products as well as to anticancer products.
• Data on the potential emergence of resistant organisms of clinical relevance and the mechanism of the development of such resistance are necessary.
• Measures to limit resistance development from the intended use of the product shall be proposed by the applicant.

• The purpose of clinical trials is to demonstrate or substantiate the effect of the product after administration at the proposed dosage regimen via the proposed route of administration and to specify its indications according to species, age, breed and sex, as well as its directions for use.
• Experimental data shall be confirmed by data obtained under normal field conditions.
• Dose determination studies: For each study, a summary of the study should be provided including including details on animals, test and control products, challenge, treatment, observation times and efficacy criteria. Results should be summarised. Tables of most relevant study results should be included.
• Dose confirmation studies: For each study, a summary of the study should be provided. Pivotal studies should be included. Results should be summarised. Tables of most relevant study results should be included.
• Field Trial: a short abstract should be provided, summarizing the study protocol and results. Tables of most relevant study results should be included.

• A tabular listing of all clinical studies and related information should be provided.

• The individual summary of the pivotal studies.

• The overall summary on the clinical safety based on the clinical trials and studies performed to demonstrate any contraindication according to species, age, breed and sex as well as any adverse reactions which it may have.