Guidance and template on the risk management plan (RMP) for novel therapy veterinary medicinal products - Scientific guideline

Guidance and a template for drafting a risk management plan (RMP) for novel therapies have become available for applicants and assessors, as the initial marketing authorisation for novel veterinary medicinal products requires the submission of a risk management plan (RMP). The applicant’s draft risk management plan will be assessed by the CVMP as part of the evaluation of the marketing authorisation application and a summary will be published as part of the European public assessment report (EPAR).

The goals of the RMP are to implement the necessary measures to:

• Detect early or delayed adverse reactions 
• Prevent clinical consequences of adverse reactions and ensure timely treatment 
• Gain information on long-term safety and efficacy of novel therapy veterinary medicinal products.

Documents

Guidance and template on the risk management plan (RMP) for novel therapy veterinary medicinal products

Adopted Reference Number: EMA/CVMP/NTWP/201952/2025