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Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance)

article  34

CELEX:  02022R0123-20250101

Confidentiality
1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/2001 of the European Parliament and of the Council () and Directive (EU) 2019/1937 of the European Parliament and of the Council (), and existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council (), including intellectual property rights.
2. Without prejudice to paragraph 1, all parties involved in the application of this Regulation shall ensure that no commercially confidential information is shared in a way which has the potential to enable undertakings to restrict or distort competition within the meaning of Article 101 TFEU.
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance)

article  34

CELEX:  02022R0123-20250101

3. Without prejudice to paragraph 1, information exchanged on a confidential basis between national competent authorities and between national competent authorities and the Commission and the Agency shall not be disclosed without the prior agreement of the authority from which that information originates.
4. Paragraphs 1, 2, and 3 do not affect the rights and obligations of the Commission, the Agency, Member States or other actors identified in this Regulation with regard to the exchange of information and the dissemination of warnings, nor do they affect the obligations of the persons concerned to provide information under criminal law.
5. The Commission, the Agency, and Member States may exchange commercially confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.