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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-2014-2015

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Sub call

H2020-PHC-2014-single-stage

Coordinator

EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH
Net EU contribution
€ 191 875,00
Address
Oxfordstrasse 2
53111 Bonn
Germany

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Region
Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00

Participants (8)

CUSTODIX NV
Belgium
Net EU contribution
€ 299 625,00
Address
Kortrijksesteenweg 214 B3
9830 Sint-martens-latem

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Vlaams Gewest Prov. Oost-Vlaanderen Arr. Gent
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
HEALTH PRODUCTS REGULATORY AUTHORITY
Ireland
Net EU contribution
€ 110 625,00
Address
Earlsfort Centre Block A Kevin O Malley House Earlsfort Terrace
2 Dublin

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Region
Ireland Northern and Western Border
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
REGIONE LOMBARDIA
Italy
Net EU contribution
€ 30 000,00
Address
Piazza Citta Di Lombardia 1
20124 Milano

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Region
Nord-Ovest Lombardia Milano
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

AZIENDA REGIONALE PER L'INNOVAZIONEE GLI ACQUISTI S.P.A.
Italy
Net EU contribution
€ 50 625,00
Address
Via Torquato Taramelli 26
20124 Milano

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Region
Nord-Ovest Lombardia Milano
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
HL7 INTERNATIONAL FONDATION
Belgium
Net EU contribution
€ 90 313,00
Address
Square De Meeus 38-40
1000 Brussels

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Research Organisations
Other funding
€ 0,00
SIEC BADAWCZA LUKASIEWICZ - POZNANSKI INSTYTUT TECHNOLOGICZNY
Poland
Net EU contribution
€ 87 625,00
Address
Ul Ewarysta Estkowskiego 6
61-755 Poznan

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Region
Makroregion północno-zachodni Wielkopolskie Miasto Poznań
Activity type
Research Organisations
Other funding
€ 0,00
STICHTING KONINKLIJK NEDERLANDS NORMALISATIE INSTITUUT
Netherlands
Net EU contribution
€ 62 875,00
Address
Vlinderweg 6
2623 AX Delft

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Region
West-Nederland Zuid-Holland Delft en Westland
Activity type
Research Organisations
Other funding
€ 0,00
AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Spain
Net EU contribution
€ 74 375,00
Address
C/ Campezo Edificio 8 1
28022 Madrid

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00