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Product title :

Responsibilities of regulatory agencies in the marketing of antimicrobials

Author(s) : K. Grein

Summary :

The regulatory agencies’ main responsibility regarding the marketing of veterinary medicinal products is to ensure that the products have a marketing authorisation with specific conditions of use adequate to ensure the quality, safety and efficacy of the product under consideration. In addition, control and surveillance systems are necessary to allow monitoring of the product after it has been authorised. In respect to antimicrobials, specific consideration must be given to minimising resistance development and retaining the effectiveness of these drugs for the treatment of humans and animals. Surveillance programmes should be in place to follow trends in resistance development, as well as in the consumption of veterinary antimicrobials, in order to provide for science-based policy recommendations regarding public and animal health.
Antimicrobial agent – Antimicrobial resistance – Antimicrobial – Marketing autorisation – Prudent use – Registration – Responsible use – Surveillance.

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