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 (only) depend 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 moment of the latest update mentioned. This kind of rules are constantly changing, thus always check whether the information reflected 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, often based on laws or rules in codes of conduct of industry associations (in that case 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 the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs/HCOs the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
  • Transparency related to clinical trials (except if it concerns transfers of value as mentioned above)
  • Transparency related to patient organizations (except if the patient organization is considered an HCO)
  • If your company is a member of MedTech / EFPIA, (or the industry association, your company is a member of, is a member of MedTech / EFPIA) the due dates are as mentioned above for MedTech / EFPIA (end of June), unless a law/regulation specifically mentions something else (and e.g. the jurisdiction is suspended/exempted to follow MedTech/EFPIA).
  • Denmark has legal requirements related to transfers of value. Following assessment against disclosure requirements, Denmark has been exempted by EFPIA from implementing the EFPIA HCP/HCO Disclosure Code
  • Iceland is not a member of EFPIA, however it has chosen to adopt the language of the disclosure code from the EU Pharmaceutical Industry code into law.
  • Turkey follows Regulation by TITCK (Turkish Medicines and Medical Device Agency). AIFD (national industry association) and EFPIA have suspended the full implementation of the EFPIA disclosure code.

 

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