Michael Healy-Rae (Kerry South, Independent)
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804. To ask the Minister for Health if changing the product information leaflet effects the profits of a pharmaceutical company (details supplied); the involvement the company, the Health Products Regulatory Authority and he have in each instance; and if he will make a statement on the matter. [30733/15]

Kathleen Lynch (Cork North Central, Labour)
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No information is available to me or the Health Products Regulatory Authority relating to the profits of the pharmaceutical company referred to by the Deputy.

I refer the Deputy to my composite reply 18761/15 of 13 May which provides information on the communications process between a medicines regulator and the pharmaceutical company.

I would like to add that the Health Products Regulatory Authority is the competent authority for the regulation of medicines and I have no function in the matter.