Pharmacovigilance refers to the science and activities relating to the detection, assessment, understanding and prevention of adverse effects caused by medicines or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.

Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions. This means that at the time of a medicine’s authorisation, it has been tested among a relatively small number of selected patients for a limited length of time.

After authorisation the medicine may be prescribed to a large number of patients, for a long period of time and alongside other medicines. Certain unanticipated side effects may emerge in these circumstances. It is therefore essential that the safety of all medicines is monitored throughout their introduction and general use in healthcare practice.

EU law therefore requires each Marketing Authorisation Holder, national competent authority and EMA to operate a pharmacovigilance system. The overall EU pharmacovigilance system operates through cooperation between the EU Member States, EMA and the European Commission. In some Member States, regional centres are in place under the coordination of the national competent authority.

Dossier Submission Review

Manufacturers wishing to introduce their products into the European market may opt to do so via the Centralised Procedure. We offer regulatory and procedural guidance every step of the way.

EUQPPV and LCPPV Services

Marketing Authorisation Holders (MAH) in the European Union require the services of a Responsible Person for Pharmacovigilance (EU QPPV) resident in the EU to be able to head the pharma company’s team responsible for post marketing surveillance for all the medicinal products placed on the market. Post marketing surveillance includes the collection of reports of adverse events (serious and non-serious) which have to be forwarded to the MAH and the European Medicines Agency (EMA). The EU QPPV is assisted by local Qualified Persons for Pharmacovigilance (LCPPV) who are located in the individual countries where the medicinal products are marketed. The LCPPV carries out literature review and follows changes in national legislations relating to medicinal products and reports the findings of their research to the EU QPPV and MAH.

Post Marketing Life Cycle Management

Post marketing life cycle management (LCM) refers to the processes carried out by the MAH or an outsourced entity to ensure the quality of a medicinal product and the safety of the patient are ensured.

Typical product lifecycle activities include:

  • Medicinal product application for authorisation via the national health procedures
  • Direct Healthcare Professional Communication (DHPC)
  • Variations to patient information leaflets (PIL) and summary of product (SPC)including Common European Submission Portal (CESP) submissions
  • Preparation of documentation for CESP submissions
  • Printing and readability testing
  • Communication with national health authorities on behalf of MAHs
  • Regulatory Intelligence for Pharmacovigilance