Policy Context. The European Parliament and Council in 2010 published Regulation (EU) No 1235/2010 which includes legislative acts which relate to increasing transparency on pharmacovigilance issues. Specifically the changes include laying down Community procedures for the authorisation and supervision of medicinal products for humans and veterinary use and establishing a European Medicines Agency and Regulation (EC) No 1394/2007 on advanced therapy medicinal purposes. In July 2014 the governance process has been changed to implement this directive into Ireland and Irish National legislation enacted in 2012 was used to implement the EU Directive into Irish law. Included in Table 3 are linked examples of EU directives and related Irish Documents. Pharmocovigilance rules for medicinal products and establishment of European Medicines Agency 2010 Regulation Links to Irish legislation source ▇▇▇▇://▇▇▇.▇▇▇▇.▇▇/ Table 3 Example of EU and legislative changes for ePrescribing A clear objective for health services provision in the 21st century is for individuals with chronic illness and co-morbidity to have minimal hospital stays with maximum care at home. Practically this approach translates to more focused health and social care support using eHealth to facilitate access to critical data. From the individual citizen perspective, the concept of Control is acknowledged as an important factor, and one which will have a direct and significant impact on the future scope of the profession of nursing and social care practice. A key message that needs to be transmitted received and understood in eHealth systems development is that healthcare is now more than ever citizen centric, the Irish eHealth strategy published in 2013 is an example of this. Additional information about the wider European perspective is also available from here.
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Sources: Grant Agreement, Grant Agreement