Regulatory Affairs

The Regulatory Affairs Department has locations in Sansaw (UK), Bladel (NL), Aulendorf (DE) and Overland Park (US) and is responsible for the initial registrations and subsequent maintenance of pharmaceuticals. The department registers products in all of the Dechra territories in the EU and North America. While Dechra is responsible for registration in some export markets, other registrations are accomplished by our licensees. 

Labelling must be agreed by the relevant regulatory authorities and to facilitate design and approval of artwork, a Graphics group has been established in Sansaw.

Pharmacovigilance (PV) is the pharmacological science relating to the collection, detection, assessment, monitoring and prevention of product complaints. The Central Pharmacovigilance Department is based in Sansaw and is responsible for coordinating the pharmacovigilance reporting to the relevant regulatory authorities. The group works closely with the Technical Advisors in the UK and US and the Local Responsible Person in each Dechra territory. They are also responsible for coordinating with our licensee and manufacturers of products that we have licensed.

Maintaining product licenses (including pharmacovigilance) is a significant workload for the department with approximately 60% of time spent keeping Dechra’s products legally in their respective markets.