Information on Functions and Services Provided 

Functions and Services

We are the Health Products Regulatory Authority (HPRA) and our role is to protect and enhance public and animal health.

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. 


Information in relation to the HPRA remit and regulatory functions can be found by clicking the following links:



Medical Devices

Blood, Tissues, Organs


Controlled Substances