Michael Healy-Rae (Kerry South, Independent)
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469. To ask the Minister for Health if the Health Products Regulatory Authority has sought third party consent in relation to releasing information requested, as submitted by a company (details supplied), health care professionals and patients with regard to Roaccutane since 1983; and if he will make a statement on the matter. [33360/15]

Michael Healy-Rae (Kerry South, Independent)
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473. To ask the Minister for Health if he is satisfied that a company (details supplied) is operating to the highest standard of accountability, transparency, legality, and otherwise, with regard to Roaccutane since 1983; and if he will make a statement on the matter. [33383/15]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 469 and 473 together.

The Health Products Regulatory Authority (HPRA) has not requested the information referred to by the Deputy from the pharmaceutical company referred to by the Deputy.

In terms of the accountability of such a company I refer the Deputy to my composite reply of 19166/15 of 19 May, in relation to the pre- and post- marketing activities that are undertaken in order to ensure the quality, safety, and efficacy of medicinal products and to monitor on an on-going basis their benefits and risks.