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Croatia
transparency obligations overview

Latest update: 29 November 2018 | Important Notes
PHARMACEUTICAL

Report Due Date

Annually, not later than 6 months after the end of the relevant reporting period. Each reporting period covers full calendar year, starting on 1 January and ending 31 December.

Authority

The Croatian association Innovative Pharmaceutical Initiative

Who Must Report

Members of the association

Covered Recipients

Healthcare professionals (HCPs) or healthcare organizations (HCOs)
MEDICAL DEVICE

Report Due Date

Annually, not later than 6 months after the end of the relevant reporting period. Each reporting period covers full calendar year, starting on 1 January and ending 31 December.

Authority

MedTech

Who Must Report

Members of MedTech

Covered Recipients

Healthcare organizations

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

How to Report

For consistency purposes, disclosures pursuant to this Code will be made using a structure set forth in Annex 1, which shall be applied on all disclosures in the Republic of Croatia.
Disclosures will be made on the relevant website, which shall be developed by the Association for the respective purpose and/or on the websites of each Member Company, with the right of unlimited access thereto via the Internet.
Disclosures shall be made in Croatian language but, following resolution of the Association, the website may be designed as bi-lingual site with the optional availability of English-language text.

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.

How to Report

An example of the template can be found in Annex II of the following source:
MedTechEurope_Code_of_Ethics.pdf
Disclosures shall be made on the EthicalMedTech website (ethicalmedtech.org) unless the Member Company is already bound by national laws, regulations or professional codes as regulated in Section 1.2 Applicability of These Disclosure Guidelines.

Resources

MedTech Code:
MedTechEurope_Code_of_Ethics.pdf
Link to MedTech Code currently published on MedTech website:
http://www.medtecheurope.org/legal-and-compliance/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 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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