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
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.