VIII.B.6. Data protection

Marketing authorisation holders and investigators shall follow relevant national legislation and guidance of those Member States where the study is being conducted [DIR Art 107m(2)]. The legislation on data protection must be followed in accordance with Directive 95/46/EC of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

For non-interventional PASS imposed as an obligation, the marketing authorisation holder shall ensure that all study information is handled and stored so as to allow for accurate reporting, interpretation and verification of that information and shall ensure that the confidentiality of the records of the study subjects remains protected [IR Art 36]. This provision should be also followed for PASS required in the risk management plan agreed in the EU or conducted voluntarily in the EU.