Panel issues open letter to European Medicines Agency to revise EU GMP Annex 12 - Use of ionising radiation in the manufacturer of medicinal products.

NewsNovember 2022

Panel issues open letter to European Medicines Agency to revise EU GMP Annex 12 – Use of ionising radiation in the manufacturer of medicinal products.

The Annex must be updated to align with current international standards and guidance on radiation sterilization including the adoption of X-ray technology. The Irradiation Panel volunteers to lead updating Annex 12. The Panel requests your support in advocating this update. Open letter can be downloaded below:

Panel note EMA Annex 12 Download

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