Pharmacovigilance consultancy for the EU, UK & Switzerland

The European Medicines Agency (EMA) is the central agency coordinating drug regulation across the EU/EEA. For pharmacovigilance (PV), EMA operates EudraVigilance – the EU-wide database for collecting and analysing suspected adverse drug reactions (ADRs) for medicines authorised in the EEA or used in clinical trials.

EMA works in conjunction with national competent authorities in each Member State to monitor drug safety, detect safety signals and coordinate regulatory responses.

A consultant helps sponsors understand the EMA’s role, ensures their PV system is compliant with EU-wide requirements (e.g. correct use of EudraVigilance, timely signal management), and acts as a bridge between the sponsor and EMA or NCAs for efficient communication and compliance.

EudraVigilance is the EU’s central electronic reporting system for suspected ADRs and serious adverse reactions. It includes two modules:

• A Post‑Authorisation Module (EVPM) – for spontaneous reports, literature reports, non‑interventional studies, etc.
• A Clinical Trial Module (EVCTM) – for reporting suspected unexpected serious adverse reactions (SUSARs) during clinical trials.

Use of EudraVigilance is mandatory for: marketing‑authorisation holders (MAHs) once a product is authorised in the EU/EEA, and for sponsors of clinical trials (for EVCTM) during the trial.

A consultant ensures the sponsor/MAH correctly implements and tests the electronic reporting infrastructure (gateway, EVWEB, local safety database), avoids technical or procedural errors in submissions, and aligns reporting timelines with EU requirements — reducing risk of non-compliance.

Once a medicinal product is authorised in the EU, the MAH must maintain a pharmacovigilance system covering collection, management and reporting of suspected adverse reactions, literature monitoring, signal detection, periodic safety updates, and risk‑management. This is a legal requirement under Directive 2001/83/EC (as amended) and related legislation, implemented via the Good Pharmacovigilance Practices (GVP) guidelines.

Moreover, the MAH must appoint a Qualified Person Responsible for Pharmacovigilance (QPPV), resident in the EU, available continuously, and responsible for oversight of the PV system, safety profile monitoring, and acting as single contact point with health authorities.

A consultant helps design and implement a robust PV system (including SOPs), supports selection or outsourcing of a compliant QPPV, and ensures that all legal requirements are properly documented and met – critical for regulatory compliance and audit readiness.

The sponsor must report all suspected unexpected serious adverse reactions (SUSARs) via the EudraVigilance Clinical Trial Module (EVCTM).

Furthermore, the sponsor must submit an annual safety report (ASR) for each investigational medicinal product (IMP) used in the trial – and include region‑specific information for the EU/EEA. 

If the trial is conducted in e.g. Sweden, the relevant national competent authority (e.g. Swedish Medical Products Agency – for Sweden) will expect compliance with its national safety reporting procedures.

A consultant ensures the safety reporting workflow is properly set up (timing, SUSAR reporting, annual reports), coordinates submissions to EudraVigilance and NCAs, and helps align trial documentation (protocol, safety monitoring plan, informed consents) with regulatory expectations – reducing risk of delays or non‑compliance.

Besides EMA, each EU/EEA Member State has a national competent authority (NCA) responsible for medicines and pharmacovigilance for products authorised nationally or marketed in that country.

A full list of national competent authorities is publicly available via EMA’s website under “National competent authorities (human)”.

If a sponsor markets or plans to market a product in several EU countries, they may need to interact with multiple NCAs – e.g. to report adverse reactions, provide safety updates, or meet local PV presence obligations.

A consultant helps identify the relevant NCAs for the countries where a product will be marketed or trialed, coordinates multi‑country reporting and compliance, and ensures that national‑level PV requirements (e.g. local contact persons) are met, avoiding fragmentation and regulatory risks.

Even though EU pharmacovigilance law sets common standards, many EU Member States require that companies maintain a “local pharmacovigilance presence” after marketing authorisation is granted – i.e. a local contact/person responsible for PV in that country. It is estimated that 17 EU countries enforce such requirements.

The local PV presence may include case management, literature screening, medical information and local language support to handle adverse reaction reports, communication with local health authorities or healthcare professionals, and other post-marketing safety obligations.

Failure to meet local PV requirements can lead to regulatory consequences, including fines, suspension or withdrawal of the marketing authorisation.

A consultant can help set up and run local PV functions – including local case handling, medical information, and contact point services – in required Member States, ensuring full compliance and freeing the sponsor from the burden of building in‑house resources country by country.