lexiara

8.

Text with EEA relevance.

The compliance part of the database shall be established in accordance with the following criteria: protection from unintended use and the safeguarding of confidential information by way of strict security arrangements; access rights based on the need-to-know principle; processing of personal data in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, as applicable; limitation of data access in scope to prevent copying larger data sets; traceability of data access for the supplier with regard to its technical documentation.

· All articles ·

Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.