SCOPE Project

The Agency for Medicinal Products and Medical Devices (HALMED) participates in the European Commission's project entitled "Joint Action on Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE)". The project is being carried out with the aim to improve the health of European citizens by encouraging collaboration among Member States for effective operation of the pharmacovigilance system in the EU. The project started on the 1st November 2013 and is planned for three years.

The purpose of this project is to provide support to EU Member States in finding solutions for establishing and implementing the pharmacovigilance system within the context of the new EU pharmacovigilance legislation with which the Croatian laws and bylaws are harmonised. The project consists of eight so-called working packages, each of them led by one Member State. With regard to recognised Croatian experience in the pharmacovigilance area, Croatia has been chosen as a leader of one of the packages relating to spontaneous adverse reaction reporting. Other countries chosen as package leaders are: United Kingdom, Spain, Portugal, The Netherlands, Hungary and Italy.

The aim of the working package led by Croatia, relating to spontaneous adverse reactions reporting is to understand and develop national plans for spontaneous reporting of medicines adverse reactions. Also, tools and methodologies for raising awareness and motivation of healthcare professionals and patients for reporting adverse reactions to competent authorities will be developed within the working project. All these measures are undertaken to ensure ever better understanding and developing best practices of spontaneous adverse reactions reporting to Member States, as well as safety signal detection and ways of implementing a transparent communication with public, where every citizen would have access to public information associated with certain medicinal product. One of the main objectives at the entire EU level is preparation of harmonised forms for spontaneous adverse reactions reporting to be used in all Member States. Taking account that some of the Member States have already implemented certain measures from the new legislation, they are in a position to provide example, based on the own experience to other Member States for an effective implementing of their activities. The main objectives of the project are:

  • Raising awareness and knowledge on procedures of adverse reactions reporting and increasing the quality of reports from healthcare professionals and patients
  • Increasing knowledge on implementing of safety signal detection in EU Member States, together with an appropriate assessment and discussion on meetings of the European Medicines Agency's (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC), as well as appropriate informing on safety signals through media
  • Increasing availability of information on medicines safety in the entire EU through Internet pages
  • Consequent information level in all Member States
  • Developing of tools and guidelines to be used by Member States to facilitate establishing and effective using of resources for quality management systems, which means planning of capacities needed for implementation of pharmacovigilance assessment
  • Proactive and proportional medicinal products monitoring through their entire life cycle to ensure an adequate identification and solving of the real and potential risks
  • Improving of collaboration between representatives of national competent authorities in order to increase the extent of work sharing and information and knowledge exchange even after the termination of the project.