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Blood, Tissues, Organs
Our aim is to make sure that medicines are as safe as possible and do what they are intended to do.
We grant licences for medicines following a review of their safety, quality and effectiveness. The decision to grant a licence is based on a review of applications submitted by pharmaceutical companies and involves an evaluation of the benefit/risk profile. All medicines have some risks associated with their use - known as side effects. However, the benefits of using a medicine should always outweigh the potential risks.
Some medicines are licensed by the European Medicines Agency /European Commission which means they can be marketed across the EU. The decision to grant these licences is based on an evaluation by experts from the national authorities including representatives from the HPRA.
Once a medicine is available for people to use in Ireland, we continue to monitor its safety, quality and effectiveness. This involves the operation of a national reporting system and inspection programme.
We encourage patients and healthcare professionals to report side effects, quality problems and other related issues to the HPRA through our website or by contacting us directly.
When new safety or quality information emerges we ensure that healthcare professionals are informed and when necessary new prescribing and dispensing advice is issued. Where appropriate, we will also highlight this information to the general public.
Where we identify a significant safety or quality concern with a medicine, there are a range of regulatory actions we can take to protect public health. These include changes to the product information, safety notices, as well as suspensions or recalls.
We grant licences to the companies who make, distribute and market medicines in Ireland. This follows an onsite inspection to ensure compliance with relevant standards and legislation. Thereafter, we audit manufacturers and wholesalers on a regular basis as part of our on-going inspection programme.
We monitor the Irish market for the importation and/or online sale of counterfeit and illegal medicines as they can pose a serious health risk for people. The HPRA uses a range of enforcement powers to tackle this activity including seizing product and taking prosecutions.
Doctors and dentists are permitted to prescribe unauthorised medicines – known as exempt products – for individual patients under their care. We record and maintain a database of all such products that are used in Ireland.
Date Printed: 23/02/2024