How we Regulate

• Our primary goal is to protect the health of those who use and benefit from the products we regulate. We assess information about a product, including relevant research, to evaluate the benefit/risk profile. The benefits of using a health product should always outweigh the potential risks. 

• Our scientific, clinical and legal expertise forms the basis of the HPRA’s independent regulatory actions and decisions. These are also informed by a number of national independently-appointed scientific experts who serve on our Advisory Committees.

• The regulation of all health products under the remit of the HPRA is based primarily on European law which is implemented into Irish legislation. It is our role to ensure that the health products sector complies with those laws and regulations. 

• The legislation differs across each of the areas we regulate. This means that our regulatory role is not the same for each product and we are involved at different stages in the product lifecycle. 

• For the majority of the products under our remit, we are responsible for monitoring their safety and quality once in use and on the market. For other products, primarily medicines, we are also involved in their assessment before they are placed on the market. In addition, we carry out compliance inspections of manufacturers, distributors and certain other health product facilities.

• We operate national reporting systems to monitor the products that we regulate. This allows anyone who experiences or has knowledge of a safety, quality or effectiveness issue to report it directly to us. Each individual report is evaluated by the HPRA and considered as part of our on-going product benefit/risk assessment.

• We actively participate at a European and global level for all products under our remit. This also gives us access to the latest product information and safety signals across the ever-evolving health products sector. Our HPRA experts are key contributors to a range of important regulatory committees and working parties, both here and internationally.

• We seek to ensure that those who make and market health products do so in accordance with the legislation. We inspect sites and investigate potential breaches of the law. Where necessary, in the interest of public health we take appropriate corrective actions including legal proceedings.