Schnellzugriffe für Fachkreise
Quick access to favorite functions and databases
Subject | Registration | Login | Forms | Register | technical info | specific info |
eServices BASG | Registration | Login | Authorisation | n.a. | basg-eservices @ages .at | Link |
Contact us | Contact | |||||
BASG Fees | Link | |||||
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REPORTING | ||||||
Pharmacovigilance | Vigiweb | Vigiweb | Forms | Link | ||
Quality deficiencies | n.a. | n.a. | Forms | |||
Medical devices vigilance | n.a. | online | Forms | MP register | Link | |
Haemovigilance | n.a. | n.a. | Forms | n.a. | ||
Tissue Safety | n.a. | n.a. | Forms | n.a. | ||
ESVAC | Registration | eServices | n.a | actual data | Link | |
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MARKETING AUTHORISATION | ||||||
Currently licensed in AT | ||||||
Lifecycle authorisations | BASG-Announcement | |||||
Authorisation of medicines | Forms | Link | Link | |||
PSUR RMP | Forms | FAQ | ||||
PSUR procedure (MAH & Consultants) | Registration | FAQ | ||||
CEP | Actions | EDQM | ||||
QRD CP June 2015 | Vers. 9.1. | QRD decisions | EMA | |||
QRD MR/DC June 2015 | Rev. 8. | CMDh | ||||
Submission via BASG eService | Registration | Login | Link | Link | ||
Submission via CESP | Registration | submission | Link | |||
Submission via EMA-Gateway | Registration | submission | ||||
eCTD Validator BASG | Link | |||||
Electronic delivery | Registration | |||||
NASA | n.a. | n.a. | Forms | Link | ||
RMS Transfer to AT | n.a. | n.a. | Link | |||
RMS AT slots | n.a. | n.a. | Link | |||
Sunset-Clause | Registration | eServices | Link | |||
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OPERATION APPROVAL | ||||||
GMP/GDP | n.a. | n.a. | Forms | Businesses licensed | ||
GMP/GDP inspection | n.a. | n.a. | Current progress | |||
Blood/Tissue inspection | Link | |||||
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CLINICAL TRIAL | ||||||
on medicinal products acc. AMG | EudraCT | n.a. | Forms | Link | ||
on medical devices acc. MPG | online-form | n.a. | Forms | Link | ||
NIS | Registration | Activity | NIS-Register | Link | ||
GCP Inspection | Current progress | Link | ||||
Compassionate Use | n.a. | n.a. | Forms | Overview | Link | |
Trials approved in AT | BASG-votings | |||||
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CERTIFICATES | ||||||
Importing to Austria | Registration | Login | Forms | Link | ||
Batch release | n.a. | n.a. | Forms | |||
CPP medicinal products | n.a. | n.a. | Forms | |||
FSC medical devices | n.a. | n.a. | Forms | |||
Classification medical devices | n.a. | n.a. | Forms | Link | ||
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DATABASES | ||||||
MRP/DCP human | MRI Product Index | HMA | ||||
MRP/DCP vete | VMRI Product Index | HMA | ||||
CP human/vete | Community-Register | EC | ||||
EPARs human | EPARs human | EMA | ||||
EPARS vete | EPARs vete | EMA | ||||
Herbal monographs | HMPC monographs | EMA | ||||
Herbal EU list | EU list | EUR-lex | ||||
CMD referrals | CMD referrals | CMDh | ||||
EMA referrals | Referrals | EC | ||||
Orphan drugs | Orphan | EC | ||||
ATC/DDD | ATC/DDD | WHO | ||||
PDCO on PIPs | PDCO | |||||
PRAC minutes | PRAC | |||||
PSUR -Reference Dates | EURDs | EMA | ||||
Clinical trials | CT Register | |||||
Suspected ADRs | Database | EMA | ||||
Medical devices | EUDAMED | |||||
GMP/GDP | EudraGMDP | |||||
CEP | CEP | EDQM | ||||
EDQM | databases |
Meldewesen
Thema | Benutzer-registrierung | Zugang | Formular | Register | Info technisch | Info fachlich |
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Nebenwirkungen | Vigiweb | Vigiweb | Formulare | Link | Link | |
Qualitätsmängel | n.a. | n.a. | Meldekarten | |||
Medizinproduktevigilanz | n.a. | online Meldung | Formulare | MP Register | Link | |
Hämovigilanz | n.a. | n.a. | Formulare | n.a. | ||
Gewebesicherheit | n.a. | n.a. | Formulare | n.a. | ||
ESVAC | Registrierung | Login | Aktuelle Daten | Link | ||
Medizinprodukteabgabe | Formular 2017 | Link |
Arzneimittelzulassung
Thema | Benutzer-registrierung | Zugang | Formular | Register | Info technisch | Info fachlich |
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Zugelassen in Österreich | ASP-Register | |||||
Lifecycle Bewilligungen | BASG-Verlautbarung | |||||
Arzneimittel Zulassung in Österreich | Formulare | Link | Link | |||
PSUR / RMP | Formulare | FAQ | ||||
PSUR-Verfahren (MAH und Konsulenten) | Registrierung | FAQ | ||||
CEP | Actions | EDQM | ||||
QRD CP Juni 2015 | Vers. 9.1 | QRD decisions | EMA | |||
QRD MR/DC Juni 2015 | Rev.8. | CMDh | ||||
Einreichung über eService BASG | Registrierung | Login | ||||
Einreichungen - CESP | Registrierung | Einreichung | ||||
Einreichungen - EMA-Gateway | Registrierung | Einreichung | ||||
eCTD Validator | Link | |||||
e-Bescheidzustellung | Registrierung | |||||
NASA | Formulare | Link | ||||
RMS Transfer auf AT | n.a. | n.a. | Link | |||
RMS AT slots | n.a. | n.a. | Link | |||
Sunset-Clause | Registrierung | login | Link |
Betriebsbewilligung
Thema | Benutzer-registrierung | Zugang | Formular | Register | Info technisch | Info fachlich |
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GMP/GDP | n.a. | n.a. | Formulare | Arzneimittelbetriebe | ||
GMP/GDP Inspektion | Bearbeitungsstand | |||||
Blut/Gewebe Inspektion | Link | |||||
Versandapotheken | Registrierung | Login | Register | Link |
Klinische Prüfungen
Thema | Benutzer-registrierung | Zugang | Formular | Register | Info technisch | Info fachlich |
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Arzneimittel gem. AMG | n.a. | EudraCT | Formulare | Link | ||
Medizinprodukte gem. MPG | n.a. | online Formular | Formulare | Link | ||
NIS | online Meldung | NIS-Register | Link | |||
GCP Inspektion | Bearbeitungsstand | |||||
Compassionate Use | Formulare | Überblick | Link | |||
Genehmigte Studien in Österreich | BASG-Abstimmungen |
Bestätigungen
Thema | Benutzer-registrierung | Zugang | Formular | Info fachlich |
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Arzneiwareneinfuhr | Registrierung | Meldung | Formulare | Link |
Chargenfreigabe | n.a. | n.a. | Formulare | |
CPP Arzneispezialität | n.a. | n.a. | Formulare | |
FSC Medizinprodukte | n.a. | n.a. | Formulare | |
Medizinprodukte Abgrenzung | n.a. | n.a. | Formulare |
Datenbanken
Thema | Register | Info fachlich |
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MRP/DCP human | MRI Product Index | HMA |
MRP/DCP vete | VMRI Product Index | HMA |
CP human/vete | Community-Register | EC |
EPARs human | EPARs human | EMA |
EPARs vete | EPARs vete | EMA |
Herbal Monographien | HMPC Monographien | EMA |
Herbal EU-Liste | EU list | EUR-lex |
CMD referrals | CMD referrals | CMDh |
Referrals | Referrals | EC |
Orphan drugs | Orphan | EMA |
ATC/DDD | ATC/DDD | WHO |
PDCO on PIPs | PDCO | |
Paed.AR | PAR | CMDh |
PRAC minutes | PRAC | |
PSUR - Reference Dates | EURDs | EMA |
Klinische Prüfungen | CT Register | |
Nebenwirkungen Verdachtsfälle | Datenbank | EMA |
PAS | EU PAS register | ENCePP |
GMP/GDP | EudraGMDP | |
CEP | CEP | EDQM |
EDQM | Databases | |
EUDAMED (Datenbank für Medizinprodukte) | EUDAMED |
Releasenotes PHAROS 2.5.0 - Änderungen für die eServices
- Release Notes 2.5.0 Externe User.pdf302 KFinden Sie hier die Releasenotes zu den Änderungen der eServices in PHAROS 2.5.0
Created: 04.06.2010 | Page last modified: 11.04.2018