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Croatia
transparency obligations overview

Latest update: 7 March 2019 | Important Notes
PHARMACEUTICAL
MEDICAL DEVICE

Pharmaceutical Companies

What is reported:

  1. Transfers of value to a healthcare organisation, including all payments made in relation to any of the categories set forth below:
    • Donations governed by Article 15 of this Code
    • Costs related to events paid directly to healthcare organisations or third parties, including costs of governed by Article 14 (sponsorships to healthcare professionals to attend events and international events), such as:
      1. Costs of hospitality, taking into consideration the exception under Article 19.2 (b)
      2. amounts of sponsorships under sponsorship agreements between Pharmaceutical Companies and Healthcare Organisations or with third parties appointed by the Healthcare Organisation to manage the Event in the name and for the account of the Healthcare Organisation;
    • Fees for services of healthcare organisations governed by Article 16.2 of this Code paid under service contracts with HCOs and the amount of any other type of funding not covered in the previous categories
      In such case, two separate amounts will be disclosed:

      1. Fees for services
      2. Expenses related to performance of respective services, if contracted
  2. Transfers of value to healthcare professionals, including all payments made in relation to any of the categories set forth below:
    • Costs of hospitality, taking into consideration the exception under Article 19.2 (b)
    • Fees for services of healthcare professionals governed by Article 16.1 and Article 16.1.2 (when the identity of the HCP participating in market research activities is known to the pharmaceutical company) of this Code paid under service contracts with HCPs and the amount of any other type of funding not covered in the previous categories.
      In such case, two separate amounts will be disclosed:

      1. Fees for services
      2. Expenses related to performance of respective services, if contracted

Medical Device Companies

Cromed is a member of MedTech Europe (see: https://www.medtecheurope.org/about-us/members/). Cromed has a link to the MedTech Europe Code of Ethical Business Practice (MedTech Code) on their website: http://cromed.hr/eticnost-poslovanja.html.

The information included in this overview is based on the MedTech Code.

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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