Import of all medicinal products, including investigational medicinal products (IMP), must be carried out by a licensed wholesaler of medicinal products, according to Article 28 of the Medicinal Products Act No. 100/2020 and Article 4 (1) of Regulation No. 699/1996 on import and wholesale distribution of medicinal products. Regulation No. 699/1996 on import and wholesale distribution of medicinal products details the requirements for import and distribution of medicinal products.
All imports of investigational medicinal products must therefore be carried out by a licensed wholesaler. A list of companies licensed to import medicinal products can be found in the European database EudraGMDP.
IMA would like to emphasize that according to Article 9 of Regulation No. 699/1996 licensed manufacturers of medicinal products are authorised to distribute through wholesale channels the medicinal products that their manufacturing license pertains to, including IMPs.