Implementation of controlled access to and distribution of medicinal products in European Union (CONTROL-EU)

Study identification

• EU PAS number:
  EUPAS1000000313
• Study ID:
  1000000313
• Official title and acronym:
  Implementation of controlled access to and distribution of medicinal products in European Union (CONTROL-EU)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Greece

  Latvia

  Netherlands

  Portugal

  Slovenia

  Spain

  Sweden
• Study description:
  This project aims to describe national implementation processes of controlled access programmes (CAP) as well as controlled distribution systems (CDS) on a given sample of eight centrally authorised medicinal products in eight different European health care systems (Austria, Greece, Latvia, Netherlands, Portugal, Slovenia, Spain and Sweden). Of special interest is to learn about national barriers and enablers as reported by key stakeholders. ; ; A mixed-method approach is foreseen for this study, including desk research followed by a cross-sectional survey and qualitative semi-structured interviews with key national stakeholders including national competent authorities (NCAs), Marketing Authorisation Holders (MAHs), health care professionals, and patients.; ; The knowledge generated in this project will provide evidence that may be used for recommendations for regulators to engage with healthcare professional bodies and other responsible parties to investigate whether CAP/CDS are feasible and needed.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Centre for Health Protection (RIVM-GZB), National Institute for Public Health & Environment

Netherlands

University Medical Center Utrecht (UMCU)

Netherlands

Department of Social Pharmacy, Faculty of pharmacy, University of Ljubljana

Slovenia

Department of Medicine/Laboratory of Hygiene and Environmental Protection, Democritus University of Thrace

Greece

University of Porto

Uppsala University

Teamit Institute

Spain

Gesundheit Österreich Forschungs und Planungs GmbH, a subsidiary of Gesundheit Österreich GmbH (GOEG); Public University of Navarre (Spain); Riga Stradins University (Latvia)

Networks

EU Pharmacoepidemiology and Pharmacovigilance (PE&PV) Research Network

Netherlands

Study timelines

Date when funding contract was signed

Planned:23/07/2024

Actual:23/07/2024

Study start date

Planned:12/09/2024

Actual:12/09/2024

Date of final study report

Planned:31/03/2026

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable