Medicines Marketing Authorization Department
- Assesses the documentation regarding quality, efficacy and safety of medicinal products submitted for marketing authorisation and renewal in national, mutual recognition and decentralised procedures and by taking on the responsibilities delegated to the competent institutions of the European Union assesses and inspects the information included in the analytical section of bioequivalence studies and the compliance of trial site with the requirements of good clinical practice; assesses the compliance of products with the definition of a medicinal product laid down in the Pharmaceutical Law.
