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GMP: EMA issues Concept Paper for Antimicrobial Resistance Risk Assessment Guideline

21.02.2013
Antimicrobial1 resistance (AMR) is an important issue to be addressed in applications for marketing authorisations of veterinary medicinal products (VMP) and related issues regarding animal pathogens must be discussed in the clinical part of the dossier. The European Medicines Agency published a concept paper for a guideline on antimicrobial resistance risk assessment, which is open for public consultation until 30 April 2013.

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