The Health Products Regulatory Authority (HPRA) is the regulatory body charged with protecting and enhancing public health by regulating medicines, medical devices and other health products. The HPRA grants licences for medicines following a review of their safety, quality and effectiveness. Medicines licensed by the EU's European Medicines Agency can be marketed across the EU; decisions to grant these licences are based on an evaluation by experts from the national authorities, including representatives from the HPRA.
The HPRA regularly monitors and re-evaluates the benefits and risks of medicines in conjunction with the EMA, regulatory authorities for medicines in other EU Member States, and the pharmaceutical companies that make and market medicines.
My Department oversees the regulatory framework which grants prescribing rights to health professionals. All prescription medications dispensed to patients in this country are prescribed by GPs and other licensed clinicians, rather than by the HSE. A decision to prescribe a medicine for a patient is based on clinical judgement and expertise, and it is the clinical responsibility of the prescriber to comply with the regulatory framework and safe prescribing guidance.
