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vetklinfo · Expert Information
Recent regulatory developments in veterinary medicinal products, marketing authorisation, GLP, GCP, GMP and pharmacovigilance.
Commission Implementing Regulations (EU) 2025/2091 and 2025/2154 establish GMP requirements for veterinary medicinal products and their active substances. An overview of the implications for quality assurance and regulatory interfaces.
Status: Applicable since 16 July 2026
Read article (German) →The EMA is consulting on a revision of its veterinary GVP guideline. Key considerations for marketing authorisation holders and pharmacovigilance professionals.
Status: Consultation open until 18 December 2026
Read article (German) →The drafts address general user safety and exposure following topical application, focusing on risk assessment and exposure scenarios.
Status: Consultation open until 31 December 2026
Read article (German) →The CVMP has adopted new Q&A guidance on PACMPs covering the preparation, submission and assessment of planned post-authorisation changes.
Status: Effective from 1 November 2026
Read article (German) →The CVMP has recommended marketing authorisation for two vaccines intended for pigs and chickens, respectively. The European Commission makes the final authorisation decisions.
Status: Positive opinions – not yet EU marketing authorisations
Read article (German) →No articles are currently available in this category.
Information and Disclaimer: These articles are provided for professional information only. No warranty is given as to their accuracy, completeness or currency. The applicable official legislation and regulatory requirements take precedence.