Translation of "vétérinaires en rapport " (French → English) :

The periodic safety update reports shall include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product.

In addition, the holder of the authorization shall request the reference Member State which granted the initial authorization to prepare an assessment report in respect of the veterinary medicinal product concerned, or, if necessary, to update it.

(19) The usual rules governing the authorization to market veterinary medicinal products must be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which may present risks which must be balanced against the desired therapeutic effect.

The Committee for Veterinary Medicinal Products (CVMP) of the EMEA pointed out in its Report on Antimicrobial Resistance and Qualitative Risk Assessment that the vast majority of antibiotics used in veterinary medicine are related to, or identical to, human medicinal products and can select for cross-resistance or co-resistance.

Whereas following a Commission veterinary inspection mission to Morocco and after receiving a comprehensive report on the control measures taken by the competent authorities of Morocco, the equine health situation appears to be under the satisfactory control of well structured and organized veterinary services;

Whereas in order better to protect human and animal health and avoid any unnecessary duplication of effort during the examination of application for authorization to place veterinary medicinal products on the market, Member States should systematically prepare assessment reports in respect of each veterinary medicinal product which is authorized by them, and exchange the reports upon request; whereas, furthermore, a Member State should be able to suspend the examination of an application for authorization to place a veterinary medicinal product on the market which is currently under active consideration in another Member State with a vi ...[+++]ew to recognizing the decision reached by the latter Member State;