Written answers

Thursday, 9 February 2017

Department of Health

Medicinal Products Regulation

Photo of Denise MitchellDenise Mitchell (Dublin Bay North, Sinn Fein)
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183. To ask the Minister for Health the powers of enforcement and investigation of the Health Products Regulatory Authority; the number of complaints made against the body in the past four years in regard to enforcement powers; the nature of those complaints; and if he will make a statement on the matter. [6475/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The powers of the enforcement and investigation officers of the Health Products Regulatory Authority (HPRA) are contained in the Irish Medicines Board Acts 1995 and 2006, Section 32(B); these are referred to as powers of Authorised Officers.

These powers include but are not limited to; entering any premises at which he or she has reasonable grounds for believing that any trade, business or activity connected with the manufacture, processing, disposal, export, import, distribution, sale, supply, storage, packaging or labelling of any relevant thing is or has been carried out on; inspect, copy or remove records, and to take samples of or remove any relevant thing found at the premises for the purposes of any test, examination or analysis.

In the past four years, one complaint has been received and processed by the HPRA, through the written complaints system, for complaints from stakeholders on the quality of service or information provided which is not in accordance with the standards of service on the HPRA website. The complaint concerned the handling of a visit to a retailer by enforcement officers and the actions taken by the officers. The complaint was thoroughly investigated by the independent HPRA complaints officer who found that the enforcement officers acted in accordance with their legal powers at all times during the visit. Opportunities for improvement were identified and these were implemented. The retailer concerned was notified of the outcome of the investigation.

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