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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 35 CELEX: 02022R0123-20250101 Personal data protection
1. Transfers of personal data under this Regulation shall be subject to Regulations (EU) 2016/679 and (EU) 2018/1725, as applicable. 2. As regards transfers of personal data to a third country, in the absence of an adequacy decision or appropriate safeguards as referred to in Article 46 of Regulation (EU) 2016/679 and Article 48 of Regulation (EU) 2018/1725 respectively, the Commission, the Agency, and Member States may carry out certain transfers of personal data to regulatory authorities of third countries with which they have put in place confidentiality arrangements where those transfers are necessary for important reasons of public interest, such as the protection of public health. Such transfers shall be made in conformity with the conditions laid down in Article 49 of Regulation (EU) 2016/679 and Article 50 of Regulation (EU) 2018/1725. |