Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Chapter II Clinical requirements

1. General principles

The purpose of clinical trials is to demonstrate or substantiate the effect of the veterinary medicinal product after administration at the proposed dosage regimen via the proposed route of administration and to specify its indications and contra-indications according to species, age, breed and sex, its directions for use as well as any adverse reactions which it may have.

Experimental data shall be confirmed by data obtained under normal field conditions.

Unless justified, clinical trials shall be carried out with control animals (controlled clinical trials). The efficacy results obtained should be compared with those from the target animal species that have received a veterinary medicinal product authorised in the Community for the same indications for use in the same target animal species, or a placebo or no treatment. All the results obtained, whether positive or negative, shall be reported.

Established statistical principles shall be used in protocol design, analysis and evaluation of clinical trials, unless justified.

In the case of a veterinary medicinal product intended primarily for use as a performance enhancer, particular attention shall be given to:

(1)

the yield of animal produce,

(2)

the quality of animal produce (organoleptic, nutritional, hygienic and technological qualities),

(3)

nutritional efficiency and growth of target animal species,

(4)

general health status of the target animal species.

2. Conduct of clinical trials

All veterinary clinical trials shall be conducted in accordance with a detailed trial protocol.

Clinical 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.

(1)

This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.