Annex 4 - Country Compliance Requirements

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1 Authorization: Approved by: Martin Mayer Date VP QM-Systems & GMP-Compliance Global Quality Management Version: 00 Page: 1 of 5

2 Country Colombia Minimum lead time Does not apply Services needing authority clearance Legal framework for determinatio n of fair market value FMV evaluation Local code requirement s / principles (general accepted criteria for the determinatio n of HCP honorarium) Speaker / Chair Consultancy Sponsoring Donations In Colombia the rules governing the topic of Medical Ethics are contained in Act 106 from Law 1438 of 2011, Act 133 from Law 1474 of 2011 And Act 17 from Law 1751 of Please reference by link Maximum HCP fees specified? Yes,. /h, HCP remuneration cap? Yes, annual cap, maximum: Yes, others (please specify), maximum: FMV has to be based on profession and / or country of residence? and FCT I recommended, Yes and FCT II recommended, In case of national engagements: Approved local FCT available Applying codex: Name, reference; AFIDRO Ethical Codex It is the multinational (mostly Brand) pharmaceutical code of conduct Please reference by link Maximum HCP fees specified? Yes,. /h, HCP remuneration cap? Yes, annual cap, maximum: Yes, others (please specify), maximum: Version: 00 Page: 2 of 5

3 Decisions from self-regulating bodies (Criminal) Court decisions regarding fair market value Employer's authorization or notification (minimum) Authority s authorization Service type: Does not specify KOL specialty: hourly rate (range): Rated reasonable? Yes No Convictions regarding hospitality? Yes, reference link Convictions regarding FMV? Yes, reference link Please specify the rules for this context Yes, lead time: Required for sponsorship, HCP services, No Disclosure reports No Adequate benefits / gifts Please note that in the context of HCP services or sponsorships no gifts are allowed (see gsop)! In other occasions gifts are allowed? Yes, Please specify the rules for this context (if any) No Both Law and Code of Ethics from AFIDRO, allows sponsorship and gifts but limited as follows: Promotional material (gimmicks): maximum 10% of legal minimum wage (~ EUR 24) Other gifts: maximum 50% of legal minimum wage (~ EUR 120). Top value in a year. Version: 00 Page: 3 of 5

4 Events Nature of events allowed Please specify the rules for this context (if any) All related with training and education Location Prohibited characteristics: Maximum category (e.g. stars of the hotel): Location has to be in balance with general cost and if possible, only within the Country. Exceptions due to security reasons and international attendance. Direct invitation to HCP or Institutions Without any commercial commitments from attendees. Scientific / training / education objective has to be the priority of the event. Proper contracts with speakers and liaisons with them should be clearance Hospitality Prohibited characteristics: Recommended value for meals: Lunch: (N/A) Dinner: (N/A) To invite HCPs with professional ties with sponsor. Any invitation without scientific / training / education purpose Related invitation that could surpass 20% of the total cost of the event. Any invitation with evident high cost. Any cultural, sports and other invitation without specific purpose related with scientific / training / education Travel regulations Travel expenses can be reimbursed for HCP services Sponsorship Restrictions for air travel? not stricter as the internal guidelines (see gsop) Version: 00 Page: 4 of 5

5 stricter as the internal guidelines:.. No major restrictions, only a proper expenses report. Transfer of money to private bank account? allowed prohibited None Approved local Fee Calculation Tool? Others Please give details about the possible remunerations for HCPs (please reference by link in case a larger space is required) There is no major condition, only a proper contract. Version: 00 Page: 5 of 5