The treatment of regulatory activities is challenged by HMRC from time to time. This is largely because regulatory activities (in general terms and as applied outside life sciences) are seen as a matter of compliance rather than simply as part of an R&D project.
As things stand, via the BioIndustry Association (“BIA”), we have been trying to reach common ground. Until we have concluded discussions with HMRC, we will support a filing position to include all pre-approval regulatory activities as qualifying direct or indirect expenditure.
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