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1. A stakeholder forum is hereby established for the purpose of facilitating the exchange of information and promoting cooperation among stakeholders in relation to the implementation of this Regulation.

2. The stakeholder forum shall have a balanced composition and be composed of relevant stakeholders, including representatives of patient organisations, health professionals, industry, consumer organisations, scientific researchers and academia, and shall represent their views. Where commercial interests are represented in the stakeholder forum, the representation of such interests shall be based on a balanced combination of large companies, small and medium-sized enterprises and start-ups. The tasks of the stakeholder forum shall encompass equally primary use and secondary use.

3. Members of the stakeholder forum shall be appointed by the Commission following a public call for interest and a transparent selection procedure. Members of the stakeholder forum shall make an annual declaration of interests which shall be made publicly available and updated, when relevant.

4. The stakeholder forum may establish standing or temporary subgroups, as appropriate, for the purpose of examining specific questions related to the objectives of this Regulation. The stakeholder forum shall adopt its rules of procedure.

5. The stakeholder forum shall hold regular meetings, which shall be chaired by a Commission representative.

6. The stakeholder forum shall prepare an annual report of its activities. That report shall be made publicly available.