The EMA's new guideline on user safety risk assessments for topically applied VMPs comes into effect in November. The PDF document provided below, is Cyton's review of the new guideline, highlighting where there is a change in approach or updated requirements for the animal health industry.
To find out more about how Cyton's safety projects team can support you with user safety projects, environmental projects and consumer safety projects, please refer to the following pages:
Regulatory Outsourcing Options
Cyton’s dedicated regulatory procedures team can support you with:
- Dossier preparation, submission & regulatory procedures
- Regulatory intelligence and strategic planning
- Life cycle management
- Key person cover
- Pharmacovigilance
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