Pharmacovigilance - SCOPE

Name of the project: Strengthening Collaborations for Operating Pharmacovigilance in EuropeJoint Action (SCOPE)

Project identification no.: 2013 21 02



Summary of the project:

The Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action runs from 2013 until 2016. It has been created to support operations of pharmacovigilance in Europe following new requirements introduced by the European pharmacovigilance legislation that came into effect in June 2012. Funded by the Consumers, Health and Food Executive Agency and with contributions from the involved member states, SCOPE will gather information and expertise on how regulators in member states run their national pharmacovigilance systems. Using this information, SCOPE will develop and deliver guidance, training in key aspects of pharmacovigilance, and tools and templates to support best practice. Through this approach SCOPE aims to support consistent approaches in pharmacovigilance operations in the EU network, which will benefit medicines safety monitoring and communications outputs thereby helping to safeguard public health.

SCOPE aims to deliver sustainable outcomes for member states which last beyond the end of the three year project through the creation of training materials, living documents and templates which can be reviewed and adapted periodically.

SCOPE is divided into eight separate work packages. Three of these are focused on more practical aspects – coordination, dissemination and evaluation - spanning all areas of the project. The other five work packages focus on pharmacovigilance topics to deliver specific and measureable objectives, ranging from improvements in Adverse Drug Reaction reporting to assessment of quality management systems. The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is the coordinator of the Joint Action, as well as being responsible for leading the coordination and dissemination work packages.

The Hungarian National Institute of Pharmacy (being part of the National Institute for Quality and Organizational Development in Healthcare and Medicines) leads Work Package 7 on quality management system. The focus of Work Package 7 is to develop common quality standards in pharmacovigilance systems, based on an understanding of EU national systems. 

Duration of the project: 11.01.2013.– 10.31.2016

Partner countries: 27 member states (except: Cyprus)

Funded by: European Commission

Total budget: 192.887,83 EUR

Contact person: Dóra Horváth (