EMA (EU)
GUIDANCE FINAL
Concept paper on the revision of the CVMP guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/383441/2005-Rev.1 Corr.1)
Published: 9/18/2026Detected: 9/18/2026
Summary preview
Clarifies and strengthens SPC (product information) expectations for veterinary antimicrobial products by explicitly tying prophylaxis and metaphylaxis language to the restrictive conditions in Articles 107(3) and…
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