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4. The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements, as necessary and proportionate for the protection of human health.

6. Regarding information or data that is, by its nature, covered by professional secrecy and that is obtained by SoHO competent authorities in carrying out SoHO supervisory activities, SoHO competent authorities may only publish or make that information or data publicly available, without prejudice to national legislation, provided that the conditions laid down in paragraph 5, point (c), are met.

1. Unless otherwise provided for in this Regulation or in national legislation on confidentiality, and without prejudice to Regulation (EC) No 1049/2001, each party 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 effective implementation of this Regulation, in particular for the purpose of authorisations, inspections, investigations or Commission controls.

2. Information and data may be exchanged on a confidential basis between SoHO competent authorities and between SoHO national authorities and the Commission, and shall not be disclosed without the prior agreement of the SoHO competent authorities from whom that information originates.

3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and SoHO competent authorities with regard to the exchange of information and the dissemination of alerts, nor the obligations of persons to provide information under national criminal law.

5. Without prejudice to national legislation on the publication of the outcome of SoHO supervisory activities, SoHO competent authorities may publish or make otherwise publicly available the outcome of SoHO supervisory activities regarding individual SoHO entities provided that the following conditions are met:

(a) the SoHO entity concerned is given the opportunity to comment on the information that the SoHO competent authority intends to publish or make otherwise publicly available, prior to its publication or release, taking into account the urgency of the situation;

(b) the information or data which is published or made otherwise publicly available takes into account the comments expressed by the SoHO entity concerned or is published or released together with such comments;

(c) the information or data concerned is made available in the interest of public health protection and is proportionate to the severity, extent and nature of the associated risk;

(d) the information or data made publicly available does not unnecessarily undermine the protection of legal rights of the SoHO entity or any other natural or legal person;

(e) the information or data made publicly available does not undermine the protection of court proceedings and legal advice.