Europe – European Medicines Agency’s Privacy Statement : For the Industry Single Point of Contact (i-SPOC) system

The European Medicines Agency (hereinafter “EMA” or “Agency”) is committed to respect the right to data protection of its staff members and the public. The Agency collects and uses personal data in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data. It aims to ensure that your personal information is collected lawfully, stored safely, and used responsibly.

This Privacy Statement explains the most essential details of the processing of personal data by the EMA in the context of the EU Regulatory Authorities-Industry Single Point of Contact (i-SPOC) system, which has been set up by the EU Executive Steering Group on shortages of medicines caused by major events (hereinafter referred to as the “EU Executive Steering Group”) on 26 March 2020 in context of the COVID19 pandemic.2

The i-SPOC system has been established, temporarily and solely in the context of the COVID-19 pandemic – for Industry at company (corporate) level – to report on current or anticipated shortages of medicinal products, authorised and marketed in the EEA/EU, used in COVID-19 patients to the European Medicines Agency (EMA), for centrally and nationally authorised products for human use…