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 |
|---|---|---|---|---|---|---|
| Nebenwirkungen | Vigiweb | Vigiweb | Formulare | 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 | Link |
Arzneimittelzulassung
| Thema | Benutzer-registrierung | Zugang | Formular | Register | Info technisch | Info fachlich |
|---|---|---|---|---|---|---|
| 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 | |||||
| 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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|
| 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/PIP | EMA |
| 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: 22.05.2019