Health Products Regulatory Authority (HPRA)
About the Health Products Regulatory Authority
The Health Products Regulatory Authority’s role is to protect and enhance public and animal health through the regulation of medicines, medical devices, and other health products.
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.
The HPRA operates 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.
Formerly known as Irish Medicines Board (IMB), we became the HPRA in July 2014.
Who can complain to the Health Products Regulatory Authority?
Anyone can report issues relating to the safety and quality of healthcare products to the HPRA. This includes patients, carers, other members of the public and healthcare professionals.
Examples of concerns or issues that can be reported to the HPRA include:
- A suspected side effect (also called an adverse reaction) experienced as a result of using a medicine.
- An adverse incident relating to the use of a medical device such as an unexpected problem or malfunction that may affect your health or cause or contribute to an injury.
- A possible quality defect which may affect the quality, safety or effectiveness of a medicine.
- A suspected side effect experienced by an animal following the use of a veterinary medicine. Harmful or unintended effects in humans exposed to veterinary medicines can also be reported to the HPRA.
- An undesirable effect such as an unintended reaction or injury resulting from the use of a cosmetic product.
How do I report an issue or concern I have about a healthcare product?
If you are concerned that you have had a side effect to a medicine, or experienced a problem with any other type of healthcare product regulated by the HPRA, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to the HPRA on your behalf.
If you wish to directly report issues relating to the use or quality of healthcare products you can use the HPRA’s online reporting service. This can be accessed on the Report an Issue section of the HPRA website.
The type of information you should include when reporting to the HPRA is outlined below. This will depend on the product in question and the particular issue you are reporting:
Medicines: Suspected side effects
- The name of the medicine and batch number (both available on packaging), the daily dose and length of treatment.
- Other medicines used.
- Details of the side effect (symptoms) experienced, when it happened including time between taking medicine and onset of side effect, how long it lasted and any treatment given in response.
- Any relevant medical history.
Medical devices: Adverse incident report
- The type and name of the device and other details such as model number, manufacturer and source of the device.
- What went wrong with the device.
- Details of any injuries suffered.
Cosmetics: Undesirable effect
- Product details such as the name and brand of the cosmetic product, model / item number, address on the pack and pack size.
- Information regarding the purchase and storage of the product such as the date and place of purchase and the expiry.
- Details of the undesirable effect (symptoms) experienced, when it happened including time between using cosmetic and onset of undesirable effect, how long it lasted and any treatment given in response.
- Any other relevant information such as a history of allergies.
Medicines: Quality defect
- The name of the medicine, marketing authorisation and batch numbers (both available on packaging), dosage form, strength and place of purchase.
- Information about the quality defect (for example, missing patient information leaflets or discoloured syrups and tablets).
- It is recommended that you also retain samples of the product. The HPRA will contact you if it wishes to inspect the product.
Is further explanatory information available?
Further information about how to report safety and quality concerns relating to healthcare products is available from the Report an Issue section of the HPRA website.
The HPRA has also published a series of consumer information leaflets that can be downloaded from its website. This includes the leaflet ‘Medicines and Side Effects’.
Health Products Regulatory Authority
Kevin O’Malley House
Dublin 2, Ireland.