S.L. 437.47 Art. 25Summary of the product characteristics.

(1) When granting a marketing authorisation, the

Veterinary Services shall inform the holder of the summary of product characteristics that it has approved.

(2) The Veterinary Services shall take all necessary measures to ensure that information concerning the veterinary medicinal product, and in particular the labelling and package leaflet, is in conformity with the summary of product characteristics approved when the marketing authorisation was granted or subsequently.

(3) The Veterinary Services shall make the marketing authorisation publicly available without delay, together with the summary of product characteristics for each veterinary medicinal product that it has authorised.

(4) The Veterinary Services shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the veterinary medicinal product concerned. The Veterinary Services shall make the assessment report and its reasons for the opinion publicly available without delay, after deleting any information of a commercially confidential nature.