Annex II, Point (2) · Commission Delegated Regulation (EU) 2021/805

Contents

Section I — general principles and requirements
Section II — requirements for veterinary medicinal products other than biological veterinary medicinal products
Section III — requirements for biological veterinary medicinal products
Section IV — requirements for specific marketing authorisation applications
Section V — requirements for marketing authorisation applications for particular veterinary medicinal products

(2)Published studies may be accepted if they contain a sufficient amount of data and sufficient details to allow an independent assessment. The experimental techniques shall be described in such detail as to allow them to be reproduced, and the investigator shall establish their validity. Summaries of studies for which detailed reports are not available shall not be accepted as valid documentation. When the substance has been previously evaluated for the establishment of maximum residues limit (“MRL”) to address certain safety requirements reference may be made to the European public MRL assessment reports (“EPMARs”). Where reference to EPMAR is made there is no need to submit studies already evaluated as part of the MRL evaluation; only new studies not available for the MRL assessment shall be provided. If the route of exposure (for example, for the user) is not identical to the route used in accordance with Commission Regulation (EU) 2018/782^note, new studies might be necessary.

Commission Delegated Regulation (EU) 2021/805

Defined terms · 2

Key facts

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