How far is the Precautionary Principle applied now?
6.28 The guiding principle of the legislation is that decisions should be taken on the basis of specific tests for safety, quality and efficacy, and on the findings of tests and studies directed to showing how the product performs against these criteria. 6.29 To illustrate this, the key provision in EU legislation which governs the grant of marketing authorisation for veterinary medicines (Directive 81/851, Article 11(1)) lays down that: “The authorisation…shall be withheld if examination of the documents and particulars establishes that…the…product is harmful under the conditions of use stated at the time of application [= the safety criterion], has no therapeutic effect, or the applicant has not provided sufficient proof of such effect as regards the species of animal which is to be treated [= the efficacy criterion], or its qualitative or quantitative composition is not as stated [= the quality criterion]”.
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