Health Products Regulatory Authority
The Health Products Regulatory Authority ( HPRA for short ; Irish An tÚdarás Rialála Táirgí Sláinte ) is an authority under the Ministry of Health of the Republic of Ireland .
tasks
The Authority's duties are to protect and improve public health by making medicines , medical devices and healthcare products regulated . The aim is to ensure the quality and safety of all healthcare products approved in Ireland based on the latest medical knowledge and to comply with EU-wide regulations. As the Medicines Agency , the HPRA is responsible for approving new drugs in Ireland. For this task, she weighs the benefits against the risk of drugs that have been applied for for marketing authorization. If the benefit-risk ratio is assessed as positive, the authority recommends approval. In addition to the pharmaceutical sector, the HPRA is also responsible for national and EU-wide legal issues in connection with blood and blood components as well as tissue and cells . The right holders of approvals are obliged to report adverse drug effects to the HPRA within the framework of the statutory provisions. The HPRA audits and inspected companies in terms of public safety. In addition to products that have already been approved, the HPRA is also responsible for clinical studies . If there are interfaces to veterinary medicine , the HPRA is also active here, because animal medicines have an indirect influence on public health through food intake.
Organizational structure
The HPRA consists of nine members who report to the Ministry of Health . There are three advisory committees. The human medicine and medical device committees are also directly attached to the Ministry of Health and Children. The Veterinary Medicine Committee, which is also part of the Ministry of Health, is advised by the Ministry of Agriculture, Food and Forestry . Each committee can form a sub-committee. For example, there is a subcommittee on clinical studies.
history
The authority was founded in 1995 under the name Irish Medicines Board (short: IMB; Irish Bord Leigheasra na hÉireann ) and replaced the then National Drugs Advisory Board .