Be Involved in Annex 1 Revision

When the first draft for the revision of Annex 1 of the EU GMP Guidelines was published, the ECA had already provided comprehensive commentation. After a detailed review of more than 6000 comments, a second draft was published in February this year. In order to avoid repeated requests for amendments which had already been submitted and rejected in the first commentary phase, the European Commission has resorted to the means of a so-called "stakeholder consultation" this time. This means that only selected organisations and interest groups may comment. The Commission specifies which sections of the new draft still require comment and defines a small margin for important further commentation. The ECA and EQPA are both invited to comment; the ECA's Annex 1 Task Force coordinates these activities. To support this Task Force and to involve the members of the ECA and the EQPA, a questionnaire has been prepared. It contains questions that could be commented on with the help of the experience of the members. The ECA, EQPA and the Task Force would therefore like to ask you to take a little time and support us with your answers.

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