Regulatory Affairs The nature of the work of the Department of Regulatory Affairs at Kleva is spread over many fields. Its main activity is to thoroughly examine all technical data supplied to it by the Research and Development Department, to look into the clinical safety and effectiveness of the products, to verify this data, and to compile the required dossier, so application may be made for approval of marketing authorizations for the products that are developed on the Greek and international market. Given the above, the RA Department always works according to standards and legislation governing the licensing of medicines the world over. Compliance with these standards is ensured by continuously updating our associates on the regulatory provisions in force. Apart from national and European legislation, personnel in the Department of Regulatory Affairs are always aware of licensing legislation in countries to which Kleva exports its products. The personnel of Regulatory Affairs Department is the intermediary between KLEVA and Τhe Authorities, National or International. The aim of the Regulatory Affairs Department is to safeguard the suitability of all licensing dossiers for the company’s products as well as our Clients in any country. The department is staffed by scientists (pharmacists, chemists and biologists) who provide Kleva with the ability to exchange know-how with distinguished pharmaceutical firms manufacturing generic products in Europe and at the same time to license and circulate its products in countries all over the world. RA team is responsible for: The life–cycle of Marketing Authorizations of all pharmaceutical products (submission of application for the approval, variation, renewal of a MA) The following of a registration procedure (National, DCP, MRP) to obtain a MA in EU or non EU countries. Preparation of the administrative documentation, clinical and non clinical documentation required for the submission of the Marketing Authorization Compilation of the Registration Dossiers in CTD-format and eCTD-format Updating of the documentation of the file of the product as well as of the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labeling according to EMA guidelines or the National Regulatory Authorities of EU or non EU-countries Drafting and approval of package artworks, assuring their compliance with the guidelines issued by the EU or the Regulatory Authorities of non-EU countries. Providing Regulatory support to all partners in Greece or abroad by supporting with the documentation required for approval, renewal or variation and answering queries of the Authorities. Supporting the Out-Licensing Activity of KLEVA by providing upgraded CTD files in line with the current European Guidelines or the National Requirements KLEVA, as a responsible marketing authorization holder (MAH), has also set up an appropriate Pharmacovigilance System, to ensure compliance with International, EU and local legal requirements, depending on the country of authorization of its products. KLEVA has permanently and continuously at its disposal an appropriately qualified person (QPPV) responsible for pharmacovigilance. Our Pharmacovigilance Partner, is committed to complying with the laws governing its operation, to keep good practices and to provide high quality services. Processing of Personal data is governed by these terms, by the relevant provisions of Greek and EU legal framework on data protection, including the General Data Protection Regulation (2016/679) and the relevant decisions, guidelines and regulations. The aim of pharmacovigilance is the safer and more effective use of medicines for everyone. It involves all activities that relate to noticing, assessing, understanding, managing and preventing adverse events of medicines for individuals and populations. For any report concerning the safety of our products please contact our Pharmacovigilance Partner at: Tel: +30 210 3259365 (24h line) Email: pv@creativephs.com Alternatively, you can report adverse events electronically to the relative National Authorities, with yellow card through its website, which for Greece is: http://www.eof.gr/web/guest/yellowgeneral Ready for working together? Please contact us GET IN TOUCH Copyright © 2020 KLEVA Pharmaceuticals SA | All Rights Reserved. Κατασκευή ιστοσελίδων by Think Plus | creative & software agency