All posts tagged HPRA

According to RTE News

The Irish Medicines Board has confirmed that a number of batches of an anti-depressant drug being recalled by GlaxoSmithKline had been placed on the Irish market. The recall was ordered following a warning from the US Food and Drug Administration. It said the active ingredient for the drug, manufactured in Co Cork, may have been contaminated with a solvent from a pharmaceutical waste tank.

Below are links to actual product recalls by regulatory authorities illustrating the contents of a recall document.

FDA Recall Example

IMB Recall Example

A qualified person (QP) is a technical term used in European Union pharmaceutical regulation (and therefore Ireland). The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements. (EudraLex, Volume 4, Chapter 1). In the USA there is no specific requirement from the FDA for a person specifically called a “qualified person” but the FDA requires that a company selects someone who is qualified to be the person who signs off on batches.

From January 1st 2014 the Irish Medicines Board (IMB) will be known as the Health Products Regulatory Authority (HPRA).