European Commission extends Deadline for Comments on the Revision of Annex 1 for the Manufacture of Sterile Medicinal Products in Eudralex Volume 4

Update: Final version of EU GMP Annex 1 published on August 25, 2022. Read more in the news "Finalised: The revised EU Annex 1 is published

Following the publication of a first revision draft of the Annex 1 on the Manufacture of Sterile Products at the end of 2017, which triggered a veritable number of comments, a second draft was issued on 20 February this year for a limited commenting by expert groups and professional and interest associations. This second commenting phase was supposed to end on 20 May 2020.

However, even such timetables do not remain unaffected by the Covid19 pandemic. The European Commission therefore published the following announcement on 30 April:
"Deadline postponed for the second targeted consultation on Annex 1
Due to the challenges posed by COVID-19, the timeline for the second targeted consultation has been extended until 20 July 2020. 
Those who have already submitted their comments are welcome to revise their contribution if they would like to. Only their latest comments will be considered.

Already in early April you could read about the possibility to actively participate in the commenting, as both the ECA and the European QP Association (EQPA) were invited to comment. The Annex 1 Task Force of the ECA coordinates these activities. A questionnaire has been prepared to support this Task Force and to involve the members of the ECA and EQPA. It contains questions that can be commented on with the help of the experience of the members. The ECA, the EQPA and the Task Force would appreciate it if you took advantage of the deadline extension to support them with your answers.

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