What EU GMP Annex 3: Manufacture of Radiopharmaceuticals requires
EU GMP Annex 3 covers the manufacture of radiopharmaceuticals for human use, including positron emission tomography (PET) products, generator-derived products such as Tc-99m, and therapeutic radiopharmaceuticals…
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Pillar: Pharmaceuticals & Life Sciences · Authority: European Commission - DG SANTE (EudraLex Volume 4) · Version: 1.0.0 · Last updated:
Primary source: https://health.ec.europa.eu/system/files/2016-11/2008_09_annex3_en_0.pdf
SHA-256 integrity: 38fed904743e4cf795bb8761769d8756fdf24d6293e5d96866be6bddc020e391
Primary Citations — 6 traced to source
- EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice, Manufacture of Radiopharmaceuticals, adopted 2008, European Commission DG SANTE
- Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation
+ 4 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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