537. Deputy Michael Healy-Rae asked the Minister for Health the regulations and agreement that were made between the Minister for Health, a pharmaceutical company (details supplied) and the Health Products Regulatory Authority, in association with Roaccutane, since 1983, and prior to marketing; the reason Roaccutane received unlimited marketing authorisation on 10 July 2009; and the role and involvement the Minister for Health, the company and the Authority have. [28362/15]

Summary

537. Deputy Michael Healy-Rae asked the Minister for Health the regulations and agreement that were made between the Minister for Health, a pharmaceutical company (details supplied) and the Health Products Regulatory Authority, in association with Roaccutane, since 1983, and prior to marketing; the reason Roaccutane received unlimited marketing authorisation on 10 July 2009; and the role and involvement the Minister for Health, the company and the Authority have. [28362/15]

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• Medicinal Products Availability

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