Members of staff of the IMB together with the assistance of the Board’s committees and individual experts review the scientific aspects relating to the safety and efficacy of medicines and medical devices used in Ireland. Once a medicine or a medical device is made available for use, the IMB monitors the type and frequency of any reported side-effects. Companies placing medicines or medical devices on the Irish market are required to keep the IMB informed of events with potential safety consequences for their products.
The Health Products Regulatory Authority also monitors the quality of medicines by conducting inspections at sites of manufacture and distribution of medicines and by random sampling of products both pre and post authorisation. The HPRA also audits and monitors the ongoing performance of Notified Bodies for medical devices, who are responsible for assessing devices before they are placed on the market. The use of medicines and medical devices for clinical research purposes also falls within the HPRA’s remit. In the case of veterinary medicines there must likewise be assurance of quality, safety and efficacy but in addition the consequences to human health of the use of medicines in animals must be considered.
In addition to its regulatory activities the Health Products Regulatory Authority also carries out enforcement of many of the regulations for which it has responsibility. Enforcement activities include investigation of potential breaches of regulations and a range of measures, including prosecution, may be applied.
You can find out more about the work of the Health Products Regulatory Authority (HPRA) on www.hpra.ie
The light-focusing structures in the eye are the cornea and the lens. This lesson describes how some eye defects can be corrected by using spectacles or contact lenses.
This lesson discusses the safety procedures that a new drug or treatment must pass before it may be sold to the public. The importance of double-blind testing is emphasised.
In the past thirty years only two new classes of antibiotics have appeared and so the problem of antibiotic resistance is becoming more serious. The World Health Organisation has classified it as a ‘serious threat that has the potential to affect anyone, of any age, in any country’.