Proposed Changes to EU Annex 1 – Manufacture of Sterile Medicinal Products The EU Annex 1 guidance for the manufacture of sterile medicinal products was first published in 1971 and was then updated with very specific topics up until 2008 which is when the last update was published. Since then, much has changed in the industry and in 2018, the EU finally issued a proposed change to that document which is a major re-write. The new version is 50 pages long vs the current versi