EN PL

EMA: Concept paper for a guideline on antimicrobial-resistance risk assessment

24.01.2013
The Committee for Medicinal Products for Veterinary Use (CVMP) intends to draft a guideline on antimicrobial-resistance risk assessment to be applied for all classes of antimicrobial agents. The guideline would apply to all new applications for marketing authorisations including extensions and some variations (where changed doses or new indications are claimed).