Skip to main content

openMedicine

Objective

The CSA will enhance the safety of cross-border healthcare through interoperable ePrescriptions. epSOS solved the message transfer problem, but encountered 2 serious “delivery” problems: the univocal identification of medicinal products (MPs) dispensed abroad, and substitution challenges.
Global SDOs (WHO, HL7, IHTSDO, ISO/CEN, GS1), EU regulatory agencies (EMA), MS Competent Authorities, major stakeholders (industry, health professionals, patients) harmonise their related efforts to deliver
• common data models - expanding upon epSOS and existing standards (ISO/IDMP) - for prescribed MPs
• a common meta-vocabulary for unambiguous definition, description, and identification of MPs
• rules to harmonise practices of therapeutic and economic substitution
• a roadmap for post-project actions and implementations
• policy recommendations for the EU-USA road mapping process (MoU)
Work will link to related research & innovation activities of SDOs, epSOS, policy and regulatory processes (eHealth Network), the three other PHC34 projects.
WP1 develops a concise conceptual framework, including use case scenarios where the identification of a MP is an issue, including pharmacological and pharmacokinetic attributes, clinical indications and risks. WPs 2 address the identification and description of the pharmaceutical products, considering implementability as essential. WP3 investigates the situation in MSs with respect to substitution, and explores options for substitution. Each track develops a set of concrete solutions and road map recommendations, validated by experts in F2F meetings and workshops in WP4. Fostering exploitation by MS regulatory agencies and communication of results is the duty of WP5.
The project involves national competent authorities, SDOs and stakeholders not part of the core team at an early stage to assure the practicability, acceptance and trust in the solutions developed.
The CSA lasts 2 years involving 8 beneficiaries and about 25 expert organisations.

Call for proposal

H2020-PHC-2014-single-stage
See other projects for this call

Funding Scheme

CSA - Coordination and support action

Coordinator

EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH
Address
Oxfordstrasse 2
53111 Bonn
Germany
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 191 875

Participants (7)

CUSTODIX NV
Belgium
EU contribution
€ 299 625
Address
Kortrijksesteenweg 214 B3
9830 Sint-martens-latem
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
HEALTH PRODUCTS REGULATORY AUTHORITY
Ireland
EU contribution
€ 110 625
Address
Earlsfort Centre Block A Kevin O Malley House Earlsfort Terrace
2 Dublin
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
REGIONE LOMBARDIA
Italy
EU contribution
€ 80 625
Address
Piazza Citta Di Lombardia 1
20124 Milano
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
HL7 INTERNATIONAL FONDATION
Belgium
EU contribution
€ 90 313
Address
Square De Meeus 38-40
1000 Brussels
Activity type
Research Organisations
SIEC BADAWCZA LUKASIEWICZ INSTYTUTLOGISTYKI I MAGAZYNOWANIA
Poland
EU contribution
€ 87 625
Address
Ul Estkowskiego 6
61-755 Poznan
Activity type
Research Organisations
STICHTING KONINKLIJK NEDERLANDS NORMALISATIE INSTITUUT
Netherlands
EU contribution
€ 62 875
Address
Vlinderweg 6
2623 AX Delft
Activity type
Research Organisations
AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Spain
EU contribution
€ 74 375
Address
C/ Campezo Edificio 8 1
28022 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)