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 German Drug Law (AMG) or the German 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.

ThemaLinks

Registration

Support authorisation holder/site

customer registration

Examples for registration (only available in German)

FAQ eServices registration

Submission / AccessLogin
User manual Online ServicesUser manual
Guidance notes Online Services

Guidance note eService inspections & surveillance (only available in German)

other guidance notes

Forms/Information for obtaining an operating licence according to AMG / BSG

Confirmation Competent person

Message from an information officer

Information on inspection preparation