Q&A Version 22 on Safety Features for Medicinal Products

Version 22 of the Q&A on Safety features contains important clarifications regarding regulatory authorities’ access to Audit Trail data.

In particular, the document clarifies the extent to which national competent authorities (NCAs) may access the audit trail, including the names and addresses of supply chain participants located outside their jurisdiction.

Establishment, management and accessibility of the repositories system

Should NCAs have access to all end-user information in the audit trail, including the names and addresses of end-users in another Member State?

Answer: All NCAs shall have full access to all audit trail data upon request. This includes information such as the corporate name and address of wholesalers and persons authorised or entitled to supply medicinal products to the public, who are involved in verifying the authenticity and decommissioning of a Unique Identifier (UI).

For more information please see the Questions and Answers (Version 22) - Safety features for medicinal products for human use published on the European Commission's website.