Commission Directive 2009/9/ECShow full title

PART 4: EFFICACY TESTS

CHAPTER I

1. General principles

The purpose of the trials described in this Part is to demonstrate or to confirm the efficacy of the immunological veterinary medicinal product. All claims made by the applicant with regard to the properties, effects and use of the product, shall be fully supported by results of specific trials contained in the application for marketing authorisation.

2. Performance of trials

All efficacy trials shall be conducted in accordance with a fully considered detailed protocol, which shall be recorded in writing prior to commencement of the trial. The welfare of the trial animals shall be subject to veterinary supervision and shall be taken fully into consideration during the elaboration of any trial protocol and throughout the conduct of the trial.

Pre-established systematic written procedures for the organisation, conduct, data collection, documentation and verification of efficacy trials shall be required.

Field trials shall be conducted in accordance with established principles of good clinical practice, unless otherwise justified.

Before the commencement of any field trial, the informed consent of the owner of the animals to be used in the trial shall be obtained and documented. In particular, the animal owner shall be informed in writing of the consequences of participation in the trial for the subsequent disposal of treated animals or for the taking of foodstuffs from treated animals. A copy of this notification, countersigned and dated by the animal owner, shall be included in the trial documentation.

Unless the field trial is conducted with a blind design, the provisions of Articles 55, 56 and 57 shall apply by analogy to the labelling of formulations intended for use in veterinary field trials. In all cases, the words “for veterinary field trial use only” shall appear prominently and indelibly upon the labelling.

CHAPTER II

A. General requirements

1. The choice of antigens or vaccine strains shall be justified on the basis of epizoological data.

2. Efficacy trials carried out in the laboratory shall be controlled trials, including untreated control animals unless this is not justified for animal welfare reasons and efficacy can be otherwise demonstrated.

In general, these laboratory trials shall be supported by trials carried out in field conditions, including untreated control animals.

All trials shall be described in sufficiently precise details so as to be reproducible in controlled trials, carried out at the request of the competent authorities. The investigator shall demonstrate the validity of all the techniques involved.

All results obtained, whether favourable or unfavourable, shall be reported.

3. The efficacy of an immunological veterinary medicinal product shall be demonstrated for each category of target animal species recommended for vaccination, by each recommended route of administration and using the proposed schedule of administration. The influence of passively acquired and maternally derived antibodies on the efficacy of a vaccine shall be adequately evaluated, if appropriate. Unless justified, the onset and duration of immunity shall be established and supported by data from trials.

4. The efficacy of each of the components of multivalent and combined immunological veterinary medicinal products shall be demonstrated. If the product is recommended for administration in combination with or at the same time as another veterinary medicinal product, they shall be shown to be compatible.

5. Whenever a product forms part of a vaccination scheme recommended by the applicant, the priming or booster effect or the contribution of the veterinary immunological product to the efficacy of the scheme as a whole shall be demonstrated.

6. The dose to be used shall be the quantity of the product to be recommended for use and the batch used for efficacy testing shall be taken from a batch or batches produced according to the manufacturing process described in Part 2 of the application.

7. If there is a compatibility statement with other immunological products in the summary of product characteristics, the efficacy of the association shall be investigated. Any other known interactions with any other veterinary medicinal products shall be described. Concurrent or simultaneous use may be allowed if supported by appropriate studies.

8. For diagnostic immunological veterinary medicinal products administered to animals, the applicant shall indicate how reactions to the product are to be interpreted.

9. For vaccines intended to allow a distinction between vaccinated and infected animals (marker vaccines), where the efficacy claim is reliant on in vitro diagnostic tests, sufficient data on the diagnostic tests shall be provided to allow adequate assessment of the claims related to the marker properties.

B. Laboratory trials

1. In principle, demonstration of efficacy shall be undertaken under well-controlled laboratory conditions by challenge after administration of the immunological veterinary medicinal product to the target animal under the recommended conditions of use. Insofar as possible, the conditions under which the challenge is carried out shall mimic the natural conditions for infection. Details of the challenge strain and its relevance shall be provided.

For live vaccines, batches containing the minimum titre or potency shall be used unless justified. For other products, batches containing the minimum active content shall be used unless otherwise justified.

2. If possible, the immune mechanism (cell-mediated/humoral, local/general classes of immunoglobulin) which is initiated after the administration of the immunological veterinary medicinal product to target animals by the recommended route of administration shall be specified and documented.

C. Field trials

1. Unless justified, results from laboratory trials shall be supplemented with data from field trials, using batches representative of the manufacturing process described in the marketing authorisation application. Both safety and efficacy may be investigated in the same field study.

2. Where laboratory trials cannot be supportive of efficacy, the performance of field trials alone may be acceptable.