Efficacy and Safety Division
- Assesses the compliance of the evidence regarding preclinical safety, efficacy and safety of use of medicinal products provided in the marketing authorisation documentation with the requirements of normative acts.
- Assesses and monitors the risk-benefit balance and risk minimisation measures for medicinal products.
- Assesses the compliance of marketing authorisation holders with good pharmacovigilance practice.
- Assess the compliance of products with the definition of a medicinal product laid down in the Pharmaceutical Law.