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Colombia
pending legislation overview

Latest update: 2 November 2018 | Important Notes

Report Due Date

Before April 30 each year

Authority

Colombia Ministry of Health and Social Protection

Who Must Report

Pharmaceutical and medical device companies

Covered Recipients

“Those who participate in any manner in the provision, insurance, or education in the health sector.”

Pharmaceutical Companies and Medical Device Companies

What is reported:

Manufacturers and distributors (‘manufacturers, distributors, importers, traders, or participants in the supply chain of drugs, supplies, devices, and medical equipment or any other health technology’) must submit direct payments and transfers of value of any type, including those made in cash and in kind. There is a non-exhaustive list in the draft:

  • funding attendance at medical, academic, or scientific events
  • funding for meals and other recreational events
  • payments for patient monitoring
  • funding for research
  • medical continuing education activities
  • medical equipment

How to Report

Provision of information should be done in accordance with the rules set out in the Resolution, following the technical annex, and with the technical tool that the Ministry of Health and Social Protection defines for that purpose.

Resources

Articles 86 and 114 of Law 1438 of 2011
Unofficial translation of resolution

Important notes:
  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

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