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Slovenia
transparency obligations overview

Latest update: 18 December 2018 | Important Notes
PHARMACUETICAL
MEDICAL DEVICE

Pharmaceutical Companies

What is reported:

Transfers of Value to an HCO, an amount related to any of the categories set forth below shall be disclosed:

  • Donations and grants for education
  • Research and Development Transfers of Value
  • Contribution to costs related to Events
  • Fees for Service and Consultancy

For Transfers of Value to an HCP, an amount related to any of the categories set forth below shall be disclosed:
  • Contribution to costs related to Events
  • Fees for Service and Consultancy

Medical Device Companies

If applicable (e.g. if your company is a member of MedTech or an industry association that is a member of MedTech): kindly refer to ‘Europe – Medical Device Companies’ for the summary in line with the MedTech Europe Code of Ethical Business Practice.

SLO-MED is a member of MedTech (see: https://www.medtecheurope.org/about-us/members/).

According to the MedTech Europe Code, National Associations shall transpose their Code at the national level by 1 January 2020.

For more (up to date) information, kindly refer to the website of the national association: https://slomed.gzs.si/.

SLO_MED refers to the MedTech Europe Code.

What is reported:

If not already obliged by local laws/regulations, companies need to make public the aggregate spend regarding educational grants on a yearly basis.

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 provided reflects the 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 case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
  • Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
  • Reporting date normally 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 and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration (unless explicitly mentioned):
    • 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)


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