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

C. DETAILED AND CRITICAL SUMMARIES

In accordance with Article 12(3), detailed and critical summaries shall be provided on the results of pharmaceutical (physico-chemical, biological or microbiological) tests, of the safety tests and residue tests, of the pre-clinical and clinical trials and of the tests assessing the potential risks posed by the veterinary medicinal product for the environment.

Each detailed and critical summary shall be prepared in the light of the state of scientific knowledge at the time of submission of the application. It shall contain an evaluation of the various tests and trials, which constitute the marketing authorisation dossier, and shall address all points relevant to the assessment of the quality, safety and efficacy of the veterinary medicinal product. It shall give detailed results of the tests and trials submitted and precise bibliographic references.

All important data shall be summarised in an appendix, whenever possible in tabular or graphic form. The detailed and critical summaries and the appendices shall contain precise cross references to the information contained in the main documentation.

The detailed and critical summaries shall be signed and dated, and information about the author’s educational background, training and occupational experience shall be attached. The professional relationship of the author with the applicant shall be declared.

Where the active substance has been included in a medicinal product for human use authorised in accordance with the requirements of Annex I to Directive 2001/83/EC of the European Parliament and of the Council(2) the overall quality summary provided for in Module 2, section 2.3 of that Annex may replace the summary regarding the documentation related to the active substance or the product, as appropriate.

Where the competent authority has publicly announced that the chemical, pharmaceutical and biological/microbiological information for the finished product may be included in the dossier in the Common Technical Document (CTD) format only, the detailed and critical summary on the results of pharmaceutical tests may be presented in the quality overall summary format.

In the case of application for an animal species or for indications representing smaller market sectors, the quality overall summary format may be used without prior agreement of the competent authorities.

(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.

(2)

OJ L 311, 28.11.2001, p. 67.