Pharmacovigilance: marketing authorisation
Applicants are responsible for ensuring the safety profile of their medicine is adequately characterised at the time of submitting their marketing authorisation application.
Applicants are required to submit a risk management plan as part of their marketing authorisation application. Risk management plans describe existing knowledge on the safety of a medicine and future pharmacovigilance activies designed to further study or monitor the product's safety.
Patient registries are organised systems that use observational methods to collect clinical data. They support pharmacovigilance activities and are often agreed at the time of marketing authorisation as part of the risk management plan.
United Kingdom's (UK) withdrawal from the European Union (EU)
EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK's withdrawal from the EU.
In this section
In other sections
Applicants at the marketing authorisation stage should also consider the regulatory information in the sections below:
- Good pharmacovigilance practices: see Modules I (Pharmacovigilance systems) and II (Pharmacovigilance system master file)
- Patient registries
- Pharmacovigilance fees
- Post-authorisation safety studies: questions and answers
- Pre-authorisation guidance - see section 3.4 on pharmacovigilance system master file (PSMF) and Eudravigilance