# Commission Implementing Decision (EU) 2016/1250 of 12 July 2016 pursuant to Directive 95/46/EC of the European Parliament and of the Council on the adequacy of the protection provided by the EU-U.S. Privacy Shield (notified under document C(2016) 4176) (Text with EEA relevance) (revoked), Division f: Product Safety and Efficacy Monitoring

Extent: E+W+S+N.I.
Status: repealed

A pharmaceutical or medical device company does not have to apply the Privacy Shield Principles with respect to the Notice, Choice, Accountability for Onward Transfer, and Access Principles in its product safety and efficacy monitoring activities, including the reporting of adverse events and the tracking of patients/subjects using certain medicines or medical devices, to the extent that adherence to the Principles interferes with compliance with regulatory requirements. This is true both with respect to reports by, for example, health care providers to pharmaceutical and medical device companies, and with respect to reports by pharmaceutical and medical device companies to government agencies like the Food and Drug Administration.

---
Source: https://www.legislation.gov.uk/eudn/2016/1250/annex/II/division/III/division/14/division/f (the official version)
Page: https://openlegislation.uk/eu-decision-2016-1250/annex-II/division-III/division-14/division-f
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.