The EU Annex 1 in the final version, 2022

The long-awaited final version of the new EU Annex 1 "Manufacture of Sterile Medicinal Products" was published on 25 August 2022.

The deadline for entry into force was 25 August 2023.

Regarding section 8.123 on freeze-drying and product transfer, the deadline for entry into force is two years from publication and will thus become mandatory on 25 August 2024.

The Annex 1 is included in the GMP Compliance Adviser (see below).

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