News about GMP/cGMP

05.05.2020

EU GMP: Consultation Deadline for Annex 1 Extended to July

On 30 April 2020, the European Commission has announced to extend the time frame for the second consultation on Annex 1 Manufacture of Sterile Products until 20 July 2020. This step is justified by the challenges arising in connection with COVID-19.

The second draft can only be commented by selected organisations and associations. In parallel, the document will be submitted to PIC/S and WHO (we reported). The Commission would like to point out that all participants who have already submitted their comments are entitled to revise their contribution if they wish. Only their latest comments will then be considered.


Source:

European Commission: Second targeted stakeholders' consultation on the revision of Annex 1



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