Independent audits confirm Lek’s quality when it comes to health, safety, and environment

  • Lek, part of Novartis, achieves  the highest quality standards through its robust, internal, and independent audit  program at all locations.
  • Lek is the only pharmaceutical  company in Slovenia, and so far the only company that has received and renewed  the EU EMAS certificate for environmentally responsible business management on  such a scale. It has also met the requirements of the environmental standard  ISO 14001, and the occupational health and safety management system ISO 45001.
  • It has also successfully met the  requirements for the international Responsible Care® certificate 14 times in a  row.
14. 3. 2022

In only a few weeks, Lek, part of Novartis, successfully passed independent audits of four international systems in the field of safety, health, and environment, at all locations. After completing separate audits, the experts determined that Lek’s processes and procedures in the field of safety, health, and environmental protection were in accordance not only with the legislation and strict internal rules set by Novartis, but also with the EU EMAS for environmentally responsible business management, the environmental standard ISO 14001, the occupational health and safety management system ISO 45001, and the internationalResponsible Care® certificate for chemical industries. 

High standards and  requirements at all four locations

Eva Podgoršek, Head of Health, Safety and Environment (HSE) at Novartis in Slovenia, said that the purpose of Lek’s robust, internal, and independent audit program in the field of health, safety, and environment is to maintain the high quality standards that patients and other stakeholders expect from Novartis. When it comes to quality, a uniform approach and criteria are enforced at all locations, that is in Ljubljana, Mengeš, Lendava, and Prevalje. Supervisory examinations encompass all business functions, including suppliers.

Lek is the only pharmaceutical company in Slovenia included in the EU Eco-Management and Audit Scheme and the only company here that enforces it on such a scale, at all its four locations in Ljubljana, Mengeš, Lendava, and Prevalje.

The circular economy project  yielding mutual benefits

The results of successful, yet extensive audits are a reflection of well-informed and qualified employees, procedural improvements, and investments in the best available technologies. As part of acquiring the Responsible Care® certificate, the results of the circular economy project and the introduction of steam condensate recovery into the public district heating network in cooperation with Energetika Ljubljana were presented. The investment has paid off in one year and has been yielding multilateral water and thermal energy savings while reducing CO2 emissions and economic costs for the past two years.

Did you know?

  • The circular economy project saves Lek and its partner Energetika Ljubljana 51,000 m3 of water every year, of which Energetika Ljubljana saves 36,000 m3, which Lek then returns to their district heating system. When it comes to water heating, Energetika Ljubljana annually saves 3,000 MWh of energy, simultaneously reducing CO2 emissions into the atmosphere by 1,100 metric tons, and the recovered heat is sufficient for a year-round supply of 300 apartments of 70 m2. In addition, Lek saves 15,000 m3 of softened water, which would otherwise be necessary for cooling steam condensate.
  • The requirements to reveal sustainability indicators and other information, and its communication are part of the EU EMAS requirements for environmentally responsible business management, the environmental standard ISO 14001, and the GRI sustainability reporting standard.
  • All Novartis employees are qualified to understand the importance of patient safety and the quality of the processes; furthermore, such training is also subject to periodic examinations.

Responsible Care Program Certificate

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The Responsible Care Program evolved as aglobal voluntary initiative “Responsible Care” in 1985 in Canada. Today, itsmission is promoted by the ICCA (International Council of ChemicalAssociations) and CEFIC (European Chemical Industry Council). It is aregistered trademark that can only be used by companies and associations goingabove and beyond their standards to promote performance in health, safety andenvironment. The aim of the program is to assure continuous improvements inthese areas by collecting data on 16 indicators. For their efforts andtransparent reporting on their activities, companies receive RCI certificatesand an annual license to use the RCI logo. The Responsible Care Program inSlovenia is run by the Association of Chemical Industries of the SlovenianChamber of Commerce and Industry.

Novartis is the leading provider ofmedicines in Slovenia,where Lek d.d., Novartis Pharma Services Inc. and Sandoz d.d., operate.Together we are building and maintaining the reputation of a dynamic, ethical,and trusted pharmaceutical company. Lek develops, manufactures, and marketseffective, safe, and high quality medicines and active pharmaceuticalingredients. With our knowledge, quality, and experience we have gained animportant role in Novartis' organizational structure, especially in theNovartis Technical Operations, Global Drug Development, Novartis BusinessServices, and the generic division Sandoz. We are the leading Sandozdevelopment center, and one of the key development sites for technologicallycomplex projects. We invest a great deal in the development, education, andtraining of our employees. Novartis invested in Slovenia more than EUR 3billion since 2003.

About Sandoz
Sandoz, a Novartisdivision, is a global leader in generic pharmaceuticals and biosimilars. Ourpurpose is to pioneer access for patients by developing and commercializingnovel, affordable approaches that address unmet medical needs. Our ambition isto be the world’s leading and most valued generics company. Our broad portfolioof high-quality medicines, covering all major therapeutic areas, accounted for2021 sales of USD 9.6 billion.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As aleading global medicines company, we use innovative science and digitaltechnologies to create transformative treatments in areas of great medicalneed. In our quest to find new medicines, we consistently rank among theworld’s top companies investing in research and development. Novartis productsreach nearly 800 million people globally and we are finding innovative ways toexpand access to our latest treatments. About 110,000 people of more than 140nationalities work at Novartis around the world.
  Find out more at

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Thispress release contains statements and forecasts of future business operations.The forecasts include estimates based on all the information currentlyavailable to us. Should these forecasts prove unreliable, the actual results ofbusiness operations could be different from those expected.

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Forfurther information, please contact:
Communication & External Engagement
Lek Pharmaceuticals d.d.
Telephone: 01 580 22 43