art_68__para_4__para

The health data access body may extend the period for responding to a health data access application by three additional months where necessary, taking into account the urgency and complexity of the health data access application and the volume of health data access applications submitted for decision. In such cases, the health data access body shall notify the health data applicant as soon as possible that more time is needed for examining the health data access application, together with the reasons for the delay.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.