Sustainability Report 2013 Lek d.d.

23 Environment 27 GRI G4-DMA 28 See Glossary of Key Terms on page 63 Health, safety and environment systems Compliance with HSE laws and standards 27 We operate in compliance with legal and other re- quirements. The Environmental Protection Act, the key environmental management regulation, dictates the contents of other im- plementing regulations in the field of water, noise, waste, packaging materials, atmospheric emissions, light pollu- tion, storage of hazardous liquids, and other areas related to environmental protection. Our waters are regulated by the Decree on the Emission of Substances and Heat in the Discharge of Wastewater from Installations for the Production of Pharmaceutical Products and Active Substances, which particularly applies to the pharmaceutical industry. Being an IPPC 28 certified company, our Lendava and Men- ge‰ sites operate in compliance with the Decree on the Type of Activities and Installations with a High Large-Scale Pol- lution Potential. Both existing IPPC permits also cover the release of greenhouse gases from cooling devices, whereas these types of emissions at the Ljubljana and Prevalje sites are included in permits dealing with atmospheric emissions. All Lek sites comply with the Decree on Limit Values for At- mospheric Emissions of Volatile Organic Compounds from Installations Using Organic Solvents. As a low-risk source, the Menge‰ site is obligated to adhere to the Decree on the Prevention of Major Accidents and Mitigation of their Consequences. We focus on timely and effective application of new legal and other requirements in our work processes and practices. Authorized persons actively monitor and identify them, en- suring appropriate internal publication after a GAP analysis. Responsibility for effective application in practice lies with the site heads / representatives of the HSE units. In 2013 a total of six inspections were carried out at all of the four sites, revealing our overall compliance with the applica- ble regulations in the majority of cases. The majority of the inspections covered the environmental aspect of our opera- tions, and one each in the field of fire safety, biological safety and risks according to the Seveso Directive. We received a warning about identified safety deficiencies with regard to fire safety at the Ljubljana site, which were resolved within the prescribed period. In 2013 we were involved in inspections covering the quality of operational processes and products related to the area of health checks and waste management. All our sites implement the Novartis Environmental Ma- nagement System (EMS). Environmental permits issued to Lek, a Sandoz company, by the Slovenian Environment Agency, specify the limit values for all atmospheric and water emissions, waste management, measures to reduce light pollution, methods for safe storage of rawmaterials and products for the company’s sites. Our adher- ence to these values results in the safe operation of our pro- duction plants without excessive impact on the environment. An accordance with legal requirements, all Lek sites have acquired environmental permits with related amendments. • Environmental permit for operation of a device with a high pollution potential (IPPC) for the Lendava site, Permit No 35407-172/2006, dated 15. 4. 2010 • Decision amending the environmental permit for the Lendava site, No. 35407-37/2011-33, dated 12. 7. 2012 • Decision amending the environmental permit for the Lendava site, No. 35406-33/2012-4, dated 15. 3. 2013 • Environmental permit for operation of a device with a high pollution potential (IPPC), for Menge‰ site, Permit No. 35407-171/2006, dated 14. 5. 2010 • Decision amending the environmental permit for the Menge‰ site, No. 35407-22/2010, dated 35407- 22/2010, dated 28. 12. 2010 • Decision amending the environmental permit for the Menge‰ site, No. 35407-54/2011, dated 16. 5. 2012 • Decision amending the environmental permit for the Menge‰ site, No 35406-24/2012-3, dated 23. 8. 2012 • Decision amending the environmental permit for the Menge‰ site, No. 35406-25/2013-6 dated 11. 11. 2013 • Environmental permit for operation of a device using VOCs, for Ljubljana site, Permit No. 35430-19/2006, dated 30. 1. 2008 • Decision amending the environmental permit for ope- ration of a device using VOCs, for the Ljubljana site, No. 35430-6/2010, dated 4. 3. 2011 • Decision amending the environmental permit for the Ljubljana site, No. 35430-9/2012-4 dated 11. 9. 2012 • Decision amending the environmental permit for the Ljubljana site, No. 35431-15/2012-2, dated 20. 11. 2012 – permit extension • Environmental permit for operation of a device with regard to emissions into waters for the Ljubljana site, Permit No. 35441-339/2006, dated 8. 11. 2010 • Decision amending the environmental permit with regard to emissions into waters for the Ljubljana site, Permit No. 35444-58/2013-2, dated 18. 3. 2014 • Environmental permit for operation of a device with regard to emissions into waters for the Prevalje site, Permit No. 35441-338/2006, dated 2. 2. 2011 • Environmental permit for operation of a device, using VOCs, for the Prevalje site, No. 35430-1/2013-6, dated 21. 8. 2013 • Water use permit for direct use of water for industri- al purposes from the public water supply network, for Lek d.d. (all sites), Permit No. 35536-19/2011, dated 15. 7. 2011 • Decision amending the partial water use permit for direct use of water for industrial purposes from the public water supply network for Lek d.d. (all sites), Permit No. 35536-17/2013-2 (concerning 35536-19/ 2011) dated 17. 4. 2013 • Water use permit for direct use of water, Permit No. 35536-20/2008 and 35536-45/2012-5 and 35536- 65/2013-8 • Greenhouse gas emission permits No. 35433-88/2009 dated 19. 8. 2009 and No. 35433-87/2009 dated 18. 8. 2009 • Decision extending the permit granting the manu- facturer an exemption status for sites Menge‰ and Lendava, No. DT 4231-77/2011 dated 30. 11. 2011 • Decision on termination of the permit granting the manufacturer an exemption status for sites Menge‰ and Lendava, No. 4231-88/2013-1 dated 3. 9. 2013