Closed Graduated Plan Procedures and Notifications
An overview of the closed graduated plan procedures is available in German.
Closed graduated plan procedures for which English documents are available
|07.01.2013||Implementation of minimum standards for blood screening tests|
|21.12.2011||Hearing for the purpose of safeguarding the quality of blood screening tests|
|26.03.2010||Supplementary statement concerning state of the art of blood screening tests|
|20.01.2010||Scientific exchange of information for the purpose of safeguarding the quality standard of blood screening tests|
Scientific exchange of information
Graduated Plan Procedure (Stufenplan) - Explanation
The general administrative regulation on the graduated plan procedure ("Stufenplan", 9 Feb 2005), according to §63 AMG, specifies the details of the cooperation and coordination between the competent federal authorities and additional authorities and services involved, the participation of the pharmaceutical entrepreneur, the procedures at the various danger levels as well as lines of communication in connection with risks associated with medicinal products. Depending on the risk level, the competent federal authority performs an information exchange with (Stage 1) or a hearing of (Stage 2) the concerned pharmaceutical entrepreneurs/ marketing authorisation holders regarding an intended measure for the purpose of risk prevention.
Donor Selection and Donor Questionnaire
A donor questionnaire is an important part of the donor selection process that ensures a high level of safety of blood-derived medicinal products. A uniform, national donor questionnaire has been developed by an expert group in Germany, which covers the eligibility criteria for donors as laid down in the German Hemotherapy Guidelines and has been evaluated in a field test.