8.

Member States shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party, for the purpose of hosting the data storage facility for all relevant data. The data storage facility shall be physically located on the territory of the Union. The suitability of the third party, in particular its independence and technical capacities, as well as the data storage contract, shall be approved by the Commission. The third party's activities shall be monitored by an external auditor, who is proposed and paid by the tobacco manufacturer and approved by the Commission. The external auditor shall submit an annual report to the competent authorities and to the Commission, assessing in particular any irregularities in relation to access. Member States shall ensure that the Commission, the competent authorities of the Member States, and the external auditor have full access to the data storage facilities. In duly justified cases the Commission or the Member States may grant manufacturers or importers access to the stored data, provided that commercially sensitive information remains adequately protected in conformity with the relevant Union and national law.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.