From March 1st Importers Shall Comply With New License Conditions

On March 1^st, 2018 the License Conditions for the Economic Activities for the Production of Medicinal Products, Wholesale and Retail Trade in Medicinal Products, Import of Medicines (other than APIs) approved by Resolution of the Cabinet of Ministers No. 929 as of November 30^th, 2016, came into force. They establish additional obligations for importers of medicinal products:

• a pharmaceutical quality system should function, including relevant elements of GMP, GDP, GSP and risk management;
• the importer must have a contract with a foreign producer and / or a supplier of the medicinal product and / or the owner of the registration certificate, which should take into account the requirements of GMP, harmonized with the EU legislation concerning imports;
• it is necessary to establish a system for selecting and storing samples of medicines;
• the authorized person of the importer must confirm the compliance of the series with the registration dossier and the import license;
• it is necessary to carry out drug stability tests;
• a contract should be concluded regarding external (outsourcing) activities.