Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000313

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

Planned
Research institutions and networks

Institutions

University of Porto
First published:
01/02/2024
InstitutionEducational Institution
Teamit Institute
Spain
First published:
12/03/2024
InstitutionOtherENCePP partner
Gesundheit Österreich Forschungs und Planungs GmbH, a subsidiary of Gesundheit Österreich GmbH (GOEG); Public University of Navarre (Spain); Riga Stradins University (Latvia)

Networks

Contact details

Marie L De Bruin

Primary lead investigator
ORCID number:
0000-0001-9197-7068
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

Study protocol_version 2.0_without Appendices.pdf

English (1.3 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable