GMP/ GDP
Good Manufacturing Practice (GMP) refers to the guidelines for quality assurance of production processes and environments in the production of drugs, active ingredients and medical devices. Reference: EMA GMP
For blood establishments and establishments processing, storing or distributing blood or blood components intended exclusively for transfusion, see Licensing and inspection of blood establishments
Good Distribution Practice (GDP) is understood to mean the guidelines for quality assurance in the context of the distribution of medicinal products. Reference: EMA GDP
Processing status
The list gives an overview of the procedures in progress at the Institute of Surveillance / AGES MEA, which are subject to the Austrian Drug Law (AMG) or the Austrian Blood Safety Law (BSG). It shows all orders, both applied for and periodic procedures, which concern national companies.
The list is arranged alphabetically according to applicants or sites and shows
- whether a procedure is being actively processed or whether (re)action is required by our customers (clock stop);
- the respective order status, from the date of the order to the assignment to the inspector or the inspection team, the execution of the inspection as well as the sending of the initial report to the party belonging to the party and the respective date of completion by the institute (two months in retrospect).
The list is updated monthly on the 10th of each month.
Electronic submission
The in the following listed applications in the sense of the Austrian Medicines Act, Austrian Blood Safety Act and Austrian Tissue Safety Act are mandatory starting from 06.04.2020 in accordance with electronic submission regulation (EEVO) over the eService inspections & surveillance:
- authorisations and certificate confirmations
- inspection of a design qualification
- third country (re)inspections
- (de-) registration of brokers
- (de-) registration of responsible persons / Qualified Persons
- official certificate
From this point on, periodic inspections according to Austrian Medicines Act (GMDP, PV), Austrian Blood Safety Act and Austrian Tissue Safety Act are also handled by eService inspections & surveillance. Inspections in the area of narcotic drugs and psychotropic substances should also be handled by eService inspections & surveillance if possible. At present, deviations are possible in individual cases after consultation.
Thema | Links |
---|---|
Registration Support authorisation holder/site | Registration examples are described in the guidance note eService inspections & surveillance (only available in German) |
Submission / Access | Login |
User manual Online Services | User manual |
Guidance notes Online Services | Guidance note eService inspections & surveillance (only available in German) |
Forms/Information for obtaining an operating licence according to AMG / BSG
- Beizubringende Unterlagen zur Erlangung einer Betriebsbewilligung:
Dokumentation für das Inverkehrbringen von Arzneimitteln28/06/2021 - Beizubringende Unterlagen zur Erlangung einer Betriebsbewilligung:
Dokumentation Herstellung/Import, Kontrolle und/oder Inverkehrbringen von Wirkstoffen28/06/2021 - Beizubringende Unterlagen zur Erlangung einer Betriebsbewilligung:
Dokumentation Herstellung, Kontrolle und Import von Arzneimitteln28/06/2021 - Beizubringende Unterlagen zur Erlangung einer Betriebsbewilligung:
Dokumentation Blutspendeeinrichtung/-bank, Plasmaspendezentrum11/12/2017