The procedure included: Sweden, Finland, Norway, Denmark and Iceland. The Company’s business partner in the scope of obtaining marketing authorisation and product distribution in the markets covered by the DCP is Glenmark. The countries covered by the Scandinavian procedure have issued positive decisions on acceptance of the submitted marketing authorisation dossier.
Bogdan Manowski, Director for Business Development, Member of the Board of Celon Pharma S.A.: This is a very important market to us. The key issues in the following months will be: acceptance of product information, reimbursement and introduction into the market. After the concluded decentralised marketing authorisation procedure, the participating countries will verify product information documents and will issue national marketing authorisation decisions. We are cooperating closely with our partner to streamline this process.
Maciej Wieczorek, PhD, President of the Board of Celon Pharma S.A.: Generic drugs penetrate the market in Scandinavian countries very quickly due to a number of incentives provided for in the system; they make a streamlined and patient-friendly changeability of therapy possible. The fact that Salmex received marketing authorisation in those markets confirms he high quality of the dossier we submitted.