GMP/ GDP

Good manufacturing practice refers to the guidelines for quality assurance of production processes and environments in the production of pharmaceuticals, active ingredients and medical devices.

For blood establishments and establishments processing, storing or distributing blood or blood components intended solely for transfusion, see Authorisation and inspection of blood establishments.

Good distribution practice refers to the guidelines for quality assurance in the context of drug distribution.

processing status

The list gives an overview of the procedures in progress at the Institute Monitoring / AGES MEA, which are subject to the Medicines Act (AMG) or the Blood Safety Act (BSG). All contracts, both requested and periodic, concerning national companies are shown.

The list is sorted alphabetically by applicant or site and shows

  • whether a procedure is actively processed or whether (re)action on the part of our customers is necessary (clockstop);
  • the respective order status, from the order date to the assignment to the inspector or the inspection team, the performance of the inspection as well as the sending of the initial report to the party's hearing and the respective date of completion by the institute (two months in retrospect).

The list is updated monthly on the 10th.

Forms

Forms for obtaining an operating permit according to AMG / BSG

  • Application for the granting / amendment of an operating permit in accordance with AMG / BSG (German only)
    26/11/2019
  • Documents required for obtaining an operating licence:
    Documentation for placing medicinal products on the market (German only)
    12/06/2019
  • Beizubringende Unterlagen zur Erlangung einer Betriebsbewilligung:
    Dokumentation Herstellung/Import, Kontrolle und/oder Inverkehrbringen von Wirkstoffen
    11/10/2017
  • Beizubringende Unterlagen zur Erlangung einer Betriebsbewilligung:
    Dokumentation Herstellung, Kontrolle und Import von Arzneimitteln
    19/11/2018
  • Checkliste zur Umsetzungsüberprüfung der FAMBO 2006
    29/01/2018
  • Beizubringende Unterlagen zur Erlangung einer Betriebsbewilligung:
    Dokumentation Blutspendeeinrichtung/-bank, Plasmaspendezentrum
    11/12/2017

Request for issuance of an official certificate

Forms for specialists subject to reporting requirements

Confirmation Qualified Person

Information on inspection preparation

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