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 was two years from publication and became mandatory on 25 August 2024.
The Annex 1 is included in the GMP Compliance Adviser (see below).