英文【EFPIA】行为准则

EFPIA CODE OF PRACTICEAdopted by the EFPIA Board on 22 March 2019, and ratified by the EFPIA Statutory General Assembly of 27 June 2019FINAL CONSOLIDATED VERSION 2019Approved by the General Assembly of 27 June 2019The EFPIA Code constitutes the collection of ethical rules agreed by EFPIA members for the Promotion of Medicinal Products to HCPs and the interactions with HCPs, HCOs and POs, with the intent of guaranteeing that these activities are conducted while respecting the most stringent ethical principles of professionalism and responsibility. This Code applies to all types of communication and interaction (traditional and digital). TABLE OF CONTENTS DEFINITIONS P. 05 PREAMBLE P. 09 INTRODUCTION P. 11 SCOPE OF THE EFPIA CODE P. 13 APPLICABILITY OF THE EFPIA CODE P. 15CHAPTER 1 PROMOTION OF POM TO HCPs P. 16 Article 1 Marketing authorization Article 2 Information to be made available Article 3 Promotion and its substantiation Article 4 Use of quotations in Promotion Article 5 Acceptability of Promotion Article 6 Distribution of Promotion Article 7 Transparency of Promotion Article 8 Promotional information provided during international Events Article 9 Personal medical mattersCHAPTER 2 INTERACTIONS WITH HCPs, HCOs AND POs P. 19 Article 10 Events and hospitality Article 11 Prohibition of Gifts Article 12 Donations and Grants to HCOs and POs Article 13 Contribution to Cost of Events and Sponsorship Article 14 Member Company funding Article 15 Contracted servicesCHAPTER 3 SPECIFIC REQUIREMENTS FOR INTERACTIONS WITH HCPs AND HCOs P. 23 Article 16 Lifelong Learning in Healthcare Article 17 Informational or Educational Materials, Items of Medical Utility Article 18 Non-Interventional Studies Article 19 Medical Samples Article 20 Member Company StaffCHAPTER 4 SPECIFIC REQUIREMENTS FOR INTERACTIONS WITH POs P. 27 Article 21 Interactions with POsCHAPTER 5 DISCLOSURE OF TRANSFERS OF VALUE FROM MEMBER COMPANIES P. 28 Article 22 Disclosure of ToVs to HCPs & HCOs and POs Article 23 Disclosure of ToVs to HCPs and HCOs Article 24 Disclosure of support and services provided to POsCHAPTER 6 PROCEDURAL REQUIREMENTS P. 32 Article 25 Enforcement Article 26 Amendments to, and guidance on compliance with, the EFPIA Code Article 27 Awareness and education Article 28 Implementation and procedure rulesANNEXES P. 36 Annex A (binding) Standardised disclosure template Annex B (binding) EFPIA disclosure guidance Annex C (binding) Guidance obligations for Member Associations under the EFPIA Code Annex D (binding) EFPIA standard operating procedure related to processing of complaints and questions submitted to EFPIA Annex E (binding) EFPIA e4ethics rules and procedure Non-binding annexes: Annex 1 EFPIA recommendation Annex 2 Principles for the use of digital channels Annex 3 EFPIA Guideline on a Quality Framework - Principles in Lifelong Learning in HealthcareAnnex 4 EFPIA guidelines applicable to solutions provided to patients DEFINITIONSDefinitions of