Medicines Marketing Authorization Department
- Evaluate documented evidence of the quality, efficacy and safety of medicinal products submitted for authorisation and renewal of authorisation under national, mutual recognition and decentralised procedures, as well as variations to the dossiers of authorised medicinal products;
- Provide scientific advice on scientific and regulatory aspects of medicinal products;
- Evaluate and check (if necessary) the compliance of the analytical part of bioequivalence study centers with Good Clinical Practice;
- Evaluate the compliance of products with the definition of medicinal products laid down in the Pharmaceutical Law;
- Prepare information and ensure communication with healthcare professionals and general public on issues related to the authorisation of medicinal products.
