Implementation of new pharmacovigilance legislation concerning the new adverse drug reactions definition (IMAGINATION)

Study identification

• EU PAS number:
  EUPAS11628
• Study ID:
  14243
• Official title and acronym:
  Implementation of new pharmacovigilance legislation concerning the new adverse drug reactions definition (IMAGINATION)
• DARWIN EU® study:
  No
• Study countries:
  Croatia
• Study description:
  Non-interventional, observational study aimed at investigating the level of implementation of pharmacovigilance legislation concerning adverse drug reactions which arise from the use outside the terms of the marketing authorisation, including overdose, off-label use, misuse, abuse and medication errors. Estimated total number of reports included in the study is 1500 cases. Five hundred cases reported at three different time point will be included in the study, before and after the implementation of the EU Directive 2010/84/EU which came into force in Croatia in July 2013, and following the implementation of the “Good practice guide on recording, coding, reporting and assessment of medication errors” which will come into the force in November 2015.
• Study status:
  Planned

Research institutions and networks

Institutions

Department for Pharmacovigilance and Rational Pharmacotherapy, Agency for Medicinal Products and Medical Devices (Phv Department -HALMED)

Croatia

Networks

It is being carried out in the collaboration with a research network at the Faculty of Pharmacy and Biochemistry University of Zagreb.

Study timelines

Date when funding contract was signed

Planned:01/01/2015

Actual:01/01/2015

Study start date

Planned:01/01/2005

Data analysis start date

Planned:01/01/2015

Date of final study report

Planned:01/06/2017

Sources of funding

Other

More details on funding

HALMED

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable