Michael Healy-Rae (Kerry South, Independent)
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462. To ask the Minister for Health if he will supply the original product information for Roaccutane and each of the 27 updates; the reason for each individual update since 1983; and if he will make a statement on the matter. [33335/15]

Michael Healy-Rae (Kerry South, Independent)
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464. To ask the Minister for Health if he will provide all the supplementary information which is distributed to prescribing doctors, pharmacists, other health care professionals and patients, in association with Roaccutane since 1983; and if he will make a statement on the matter. [33337/15]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 462 and 464 together.

The currently available product information (i.e. Summary of Product Characteristics and Package Leaflet) for Roaccutane has been the subject of a number of changes since 1998.  As with all medicines, any change to this information requires approval by the Health Products Regulatory Authority (HPRA) or another EU Member States Medicines Agency on foot of a formal application to vary the authorisation and the submission of relevant supporting data. In practice, product information is very frequently updated as new data become available through various sources of post-marketing experience, including further studies, literature reviews, and evaluation of adverse reaction data. In this context there have been numerous updates and changes to the product information for Roaccutane from January 1998 until now.

The current product information was supplied to the Deputy on 26 May 2015 in response to a previous parliamentary question. Information on the various changes over the years would require a detailed and time-consuming search by the HPRA through archived material and various databases used over the time. As stated in my response on 22nd September 2015 (Composite reply 30562/15) I am happy to facilitate a meeting between the Deputy and the HPRA to discuss the Deputy's information requests.

Details of supplementary information, other than information contained in the Summary of Product Characteristics and Package Leaflet were provided to the Deputy on 13 May 2015 (Composite reply 18761/15).