Advice on the global shortage of acetonitrile

06 February 2009

The Irish Medicines Board is aware that there is currently a global shortage in supply of acetonitrile, a solvent commonly used by the pharmaceutical industry in manufacture and analysis of drug substances and drug products. As a consequence of the restricted availability of this solvent, Marketing Authorisation holders may currently be evaluating alternative solvents for use in manufacture and/or analytical methods. Any changes to registered processes must be approved by the IMB prior to implementation and PA/VPA holders are advised to submit the appropriate variation applications (type 1A or 1B notifications or type II variations as appropriate) to the IMB Receipts and Validation section in a timely fashion. Please be advised that for type 1A and 1B notifications, all relevant conditions must be met, and the appropriate supporting documentation and accompanying Notice to Applicants checklist submitted with each application. Variations which require urgent assessment in order to alleviate risk of product shortage should be highlighted in the accompanying cover letter. For further advice on applications please contact the Irish Medicines Board on 01-6764971.