Compliance, integrity and transparency

Compliance, integrity and transparency

Krka is a company with a long tradition, building its successful business story on integrity and dedication to the highest ethical standards.

Ethics in clinical trials and R&D

We recognise the major importance of clinically tested medicines and therefore monitor their efficacy, safety and quality before and during registration procedures and after obtaining relevant marketing authorisations. We therefore conduct many bioequivalence studies, do research in pre-authorisation phases, and support post-authorisation clinical studies. All clinical trials are conducted in line with the applicable legal requirements, good practice guidelines, the Helsinki Declaration and the Regulation (EU) 2016/679 (General Data Protection Regulation).

Legislative and regulatory compliance

When working and carrying out tasks, all employees consider fundamental ethical principles of honesty, loyalty, professionalism and applicable regulations, and Krka’s internal rules.

Comprehensive and accessible reporting

Comprehensive and accessible reporting is of key importance for various stakeholders and the general public. As a public listed company whose shares are listed on the Ljubljana Stock Exchange (LJSE) and the Warsaw Stock Exchange (WSE), we comply with national laws and EU legislation and act in accordance with other regulations on internal and controlled information reporting, financial statements, and business reports, which we regularly make public in the electronic information dissemination system.

Fair marketing and sales practices

We give healthcare professionals integral, accurate, up-to-date and balanced information on our medicines and the treatment doctrine. Our relationships with the expert community are transparent and traceable, and we strictly follow all laws and regulations in that area.

Tax policy and transparency

Krka Group Tax Strategy and Krka Group Tax Code of Conduct set out the policy, objectives, guidelines, and principles of tax management based on the principles, rules of ethical conduct, and good business practices and standards of conduct defined in Krka’s Code of Conduct.

Goals

Maintain and upgrade the required integrity of research data.
Ensure that corrective actions related to ethics in clinical trials are not required.
Publicly disclose any transfer of assets to healthcare professionals, healthcare organisations and patient associations on a regular basis.
Upgrade annual and interim reports as regards GRI standards.
Ensure timely and thorough examination of familiarity with relevant codices the employees must comply with in their work.

OBJECTIVES BY 2028

No corrective actions as regards ethics in clinical trials

Documented cases of fraud, corruption, violation of compliance, unethical, unprofessional, or unlawful conduct of employees: 0

Violation of human rights at the Krka Group: 0

By adhering to Krka’s principles for managing the tax area, pursue a zero rate of adjustments and penalties in tax audits or inspections

Krka around the world

Compliance, integrity and transparency

Ethics in clinical trials and R&D

Legislative and regulatory compliance

Comprehensive and accessible reporting

Fair marketing and sales practices

Tax policy and transparency

Goals

OBJECTIVES BY 2028

INTEGRITY AND COMPLIANCE

KRKA’S CODE OF CONDUCT

CHIEF COMPLIANCE OFFICER

TRANSPARENCY AND REPORTING

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