Sustainability Report 2013 Lek d.d.

45 Environment 69 RC KPI 22, GRI Indicator G4-EN30, G4-DMA 2.9.3 Providing storage and distribution safety 2.9.3.1 Storage At Lek, a Sandoz company, handling and storage of ha- zardous chemicals are carried out in accordance with both statutory requirements and Novartis' guidelines. All of our warehouses for hazardous liquids were declared with the Ministry of Health, whereas specific sites have plans for the management of hazardous liquids in place in accordance with the legal requirements. In above-ground tank storage of hazardous liquids, we pro- vide appropriate retarding catchment systems preventing liquid spillage into the environment. In addition, the tanks are fitted in a way to enable detection of any spillage at any time. Chemicals for manufacture and storage purposes, and in the field of waste management are classified and labelled according the GHS (Globally Harmonized System). They system was further upgraded in 2013. 2.9.3.2 Distribution 69 From our production sites in Slovenia, 6,720 consignments of finished products and APIs were dispatched to 93 countries in 2013. During the transport of both non-hazardous and hazar- dous goods, no accidents occurred. Compared to the previ- ous year, the volume of distributed goods increased slightly and amounted to 19,421 t (17,816 in 2012). In September 2013, new EU guidelines on Good Distribution Practice of medicinal products for human use (GDP) entered into force. We implemented these guidelines in our distribu- tion processes for all transport methods. In the organization of international road transport, we conti- nued with the implementation of the "Control Tower" business model organized by DHL Belgium. With the optimization of transport cost, especially with a good planning of shipments and utilization of vehicles, target savings were achieved. In the organization of air transport, we successfully upgraded the cooperation with our partner DHL Global Forwarding, and carried out two workshops where we focused on the quality of the executed transport service in line with new GDP guide- lines. A regular local call for bids was put out for sea freight for- warding services, bringing us some savings. The trend of transition from air to sea transport will also continue in 2014 in order to reduce cost and provide better quality service in terms of GDP. 2.9.4 Chemical safety With its chemical safety system, Lek, a Sandoz company, ensures safe handling of chemicals in laboratories as well as in the API and finished products manufacturing process. In accordance with the legal requirements for the handling of chemicals and the Novartis' guidelines, we keep our employ- ees informed of their hazardous properties. By taking into account the type of technology used in the manufacture, and the procedures for using chemicals in laboratories, we as- sess the risks and determine technical and organizational measures to ensure safety in their use. We have established a system for collecting data on the manipulation of chemicals subject to statutory reporting, a system for the preparation of registration dossiers for the registration of strategic raw materials (intermediates) pursuant to the REACH Regula- tions (Registration, Evaluation, Authorization and Restric- tion of Chemical Substances), and the Globally Harmonized System (GHS) of labelling to meet the requirements of the manufacturing process and of the buyers of our APIs. In the area of toxicology and pharmacology, we determine exposure limit values for APIs and strategic intermediates. By determining the exposure limit values and performing measurements in the working environment, we determine appropriate technical and organizational measures. Lek HSE systems HSE function The HSE function employs the HSE Director and persons responsible for individual fields of expertise. By the autho- rity of the Board of Management, they are responsible for the compliance of areas of expertise with Slovenian laws and Novartis’/Sandoz’ standards, for representation of Lek in the area of expertise conducting inspections, conducting periodic internal audits, and monitoring the im- plementation of corrective measures, consulting and pro- fessional assistance in the implementation of preventive measures at sites as well as communication of identified risks to the management team. HSE department The HSE system has been established at all four sites of Lek d.d. in Slovenia. HSE roles, responsibilities and authorities are determined on the basis of the organiza- tional structure and functional organization. At multi-unit sites, activities are performed following the Host-Guest principle, whereby uniformity of HSE standards is ensured within each individual location. The same principle applies to our contract partners. The largest unit having a suita- ble HSE organization in place is the Host. The Host sets internal standards for individual sites that also apply to the Guests. HSE organization, human resources and training