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 is 25 August 2023. Regarding section 8.123 on freeze-drying and product transfer, the deadline for entry into force is two years from now and will thus become mandatory on 25 August 2024.

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

More details and more extensive information on the final Annex 1 will be published in our newsletter LOGFILE and on our GMP:Blog.

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