About Us

We are the Health Products Regulatory Authority (HPRA) and our role is to protect and enhance public and animal health by regulating medicines, medical devices and other health products. It is also our role to monitor the safety of cosmetics.

We are a state agency that puts the health of people and animals at the core of everything we do. We use our scientific and clinical expertise to review and monitor health products available in Ireland or exported abroad. Our aim is to make sure that health products we regulate are as safe as possible and do what they are intended to do. 

Formerly known as Irish Medicines Board (IMB), we became the HPRA in July 2014. Our new name better reflects our broader remit and regulatory functions which have expanded over a number of years to include:

• Human medicines
• Veterinary medicines
• Clinical trials
• Medical devices
• Controlled drugs
• Blood and blood components
• Tissues and cells
• Cosmetic products
• The protection of animals used for scientific purposes
• Organs intended for transplantation

The HPRA functions matrix outlines all of our key functions for each of the products / areas we regulate. Additionally, the video below provides an overview of our work. 

What We Do

• We grant licences to companies to make, distribute and market medicines after a review of their safety, quality and effectiveness.
• We continuously monitor medicines, medical devices and other health products, responding quickly to any safety or quality concerns.
• We produce safety and quality information to support the safe use of health products. 
• We inspect companies and facilities which test, make or distribute health products to ensure that they comply with relevant standards and legislation.

What We Regulate

• We are responsible for regulating a wide range of health products available in Ireland. This includes human and veterinary medicines, medical devices, blood components and human tissues and cells.
• We regulate manufacturing, wholesale and distribution companies, medical device notified bodies as well as other health product facilities.
• Our role involves regulating other related areas including clinical trials and human organs for transplantation.
• It is also our role to monitor the safety of cosmetics.
• We license and monitor the use of animals for scientific or educational purposes, ensuring that the 3R principles (replacement, reduction and refinement) are applied.