Receiving a marketing authorisation (MA) marks an important milestone, but from a pharmacovigilance perspective it represents the beginning of continuous safety oversight. Once a medicinal product is placed on the market, the Marketing Authorisation Holder (MAH) becomes responsible for continuously monitoring and evaluating its safety under real-world conditions.
Safety requirements, regulatory expectations and scientific knowledge continue to evolve throughout a product’s lifecycle. The MAHs must therefore maintain a functioning pharmacovigilance system capable of detecting, assessing and communicating emerging risks while remaining inspection-ready at all times.
This blog outlines key post-approval pharmacovigilance responsibilities in the European Union (EU). Read also our other blog discussing post-approval requirements from regulatory affairs and quality perspectives.
MAH’s pharmacovigilance obligations after marketing authorisation approval of a medicinal product
Post-authorisation pharmacovigilance is set on three major concepts: case management, risk management and signal management. These key responsibilities are mostly handled through routine activities, that provide the base for a robust product benefit-risk assessment, such as the below activities (the list is not exhaustive);
- Continuous safety monitoring:
Ongoing collection, management and medical evaluation of safety data, including expedited reporting of Individual Case Safety Reports (ICSRs) in accordance with regulatory timelines.
- Periodic Safety Update Reports (PSURs):
These structured benefit-risk evaluation reports provide cumulative safety data, signal evaluations, benefit-risk analysis, risk minimisation effectiveness review with conclusions and proposed actions.
- Literature monitoring (global and local)
MAHs must conduct systematic and regular screening of scientific and medical literature to identify ICSRs and emerging safety signals.
- Maintenance of the Pharmacovigilance System Master File (PSMF):
The PSMF is a detailed description of the MAH’s pharmacovigilance system, maintained in the EU and available for inspection.
- Ensuring a Qualified Person Responsible for Pharmacovigilance (QPPV):
Each MAH must appoint an EU-based QPPV with overall responsibility for the establishment and maintenance of the pharmacovigilance system.
- Establishing and maintaining Safety Data Exchange Agreements (SDEAs):
SDEAs are legally binding agreements defining pharmacovigilance responsibilities between the MAH and partners (e.g., distributors, co-marketing partners, licensors, CROs).
- Regular audits (internal/external) and oversight of third parties:
MAHs must implement a risk-based pharmacovigilance audit program to verify compliance and effectiveness of the PV system.
- Safety communication and regulatory interaction:
MAHs must promptly communicate significant safety concerns to competent authorities and healthcare professionals through Direct Healthcare Professional Communications (DHPCs), Urgent Safety Restrictions (USR), and coordination with EMA, National Competent Authorities (NCAs) and PRAC.
- Risk Management Plans (RMP):
Every new product requires a Risk Management Plan (RMP) at the time of authorisation, and a risk management plan is a living document that needs to be maintained well during the post‑approval period as one of the key components of the benefit risk assessment.
- Post‑Authorisation Commitments (PACs):
Marketing authorisation nowadays often comes with specific obligations, especially for products approved under exceptional circumstances, conditional approval, or accelerated timelines. MAHs must ensure timely execution of these commitments, such as Post‑Authorisation Safety Studies (PASS) and the execution of additional Risk Minimisation Measures (aRMMs) as part of the risk management strategy.
- Signal management:
Once a product is marketed, real‑world use in vide user population can reveal rare adverse events, long‑term risks, drug interactions or population‑specific issues. Therefore, the MAHs must operate a signal management process covering signal detection, validation, evaluation and prioritisation, assessment and analysis, as well as, outcome handling and regulatory communication. Signal outcomes can lead to updates in SmPC/PIL, safety communications, RMP modifications, or post‑authorisation studies.
Marketing authorisation approval is not the end of safety evaluation but the beginning of continuous pharmacovigilance responsibility. Together, these activities ensure that a product’s safety profile is continuously assessed, managed and communicated throughout its time on the market.
Medfiles supports MAHs in establishing, maintaining and developing compliant pharmacovigilance systems, from initial setup to ongoing lifecycle management and inspection readiness – acting as a reliable partner throughout the product lifecycle.
Author: Arda Sanaktekin, Drug Safety Expert
Arda Sanaktekin joined the Medfiles Pharmacovigilance team in August 2025 as a Drug Safety Expert. She holds a pharmacy degree and an MSc in Toxicology. Arda has gained extensive experience in pharmacovigilance, medical information and quality oversight within international companies. Her background enables her to approach drug safety from both a scientific and operational perspective, ensuring that regulatory requirements are translated into practical, workable processes.
At Medfiles, Arda is responsible for a range of pharmacovigilance activities, including global literature review, regulatory intelligence and vendor management. She is committed to delivering high-quality, reliable support that strengthens compliance and ensures patient safety across diverse product portfolios.
Author: Saara Mikkola, Head of Operations, Pharmacovigilance, EU QPPV
Saara Mikkola joined Medfiles Pharmacovigilance team in 2020 as a Drug Safety Expert, and in 2022 she was promoted to Safety Manager and later to Head of Operations, Pharmacovigilance. She works as an EU QPPV for Medfiles and has her focus on post-market pharmacovigilance services.
Saara has a master’s degree in pharmacy and graduated from the University of Helsinki, Finland, in 2012. She has worked within the pharmaceutical industry for over 10 years with her focus on pharmacovigilance. Saara has gained her expertise through diverse pharmacovigilance tasks and responsibilities. She is well-versed in the operational aspects of pharmacovigilance, including case processing, quality management, compliance with regulatory requirements (EU regulation), and maintaining pharmacovigilance systems.
She is adept at working in cross-functional teams, collaborating with different stakeholders, and adapting to the ever-evolving pharmacovigilance landscape and technologies.
See also:
- Additional risk minimisation measures (aRMMs) – from requirement to implementation
- How do post-marketing drug safety practices differ between Japan, the US, and the EU
- Safety database is a fundamental element of case processing
- Outsourcing ICSR processing – benefits and considerations
- Global pharma company & Medfiles: Obtaining and maintaining marketing authorisations
