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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
After obtaining marketing authorisation, there are both European and national mechanisms for supervising the safety and efficacy of pharmaceutical products. The pharmacovigilance system in the European Union operates between member states’ regulatory authorities, the European Commission and the European Medicines Agency. In some member states, regional centres operate under the coordination of the national competent authority. The agency's role is to coordinate the EU pharmacovigilance system and to operate specific systems, services and processes as laid down in the EU legislation. The National Organisation for Medicines is the responsible authority for the pharmacovigilance in Greece.
What data protection issues should be considered when conducting pharmacovigilance activities?
Every marketing authorisation holder has particular pharmacovigilance obligations to observe any adverse effects and report them to the competent Greek and European authorities. However, the data detailing adverse effects in patients should be handled carefully and according to the relevant Personal Data Law (2472/1997), which will be amended following the implementation of European Regulation 679/2016 (the General Data Protection Regulation).
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