Before a medicinal product receives a marketing authorisation a scientific evalution must be performed. Assessment of the marketing authorisation application is performed by the relevant authorities to evaluate the quality, efficacy and safety of the medicinal product. If the benefits are considered to outweigh the risks the medicinal product will be granted a marketing authorisation.
Information for marketing authorisation holders and representativesReported Medicine Shortage
Information about reported medicine shortage and instructions on what to do in important cases.Pharmacovigilance
Monitoring the safety of a medicine once it is on the market is the cornerstone of pharmacovigilance.Importation by Individuals of Medicinal Products for Personal Use
Information on requirements and rules regarding importation of medicinal products by individuals.