In the COVID-19 crisis, our operations in the UK, France and Germany can’t buy hand sanitiser. Can we make our own?

April 01, 2020

Key Takeaways

  • With hand sanitiser gel stocks under pressure worldwide, increasing numbers of businesses are considering how they could begin direct production of their own to ensure that they have sufficient stock for their own use.
  • The World Health Organisation has recently published a guide to local hand sanitiser production.
  • Sanitisers are not considered medicines or medical devices from an EU regulatory perspective, but are subject to regulation within the EU as biocidal products. However, in response to COVID-19, authorities in the UK, France and Germany have recently relaxed key aspects of their local regulations in a bid to ensure that supply meets the unprecedented level of demand.
  • If your business plans to manufacture its own sanitisers following the WHO Guide, using ethanol or isopropyl as the active ingredient, and gets its active ingredient from approved sources, approval may now not be needed to do so, or, where approval is still needed, the path to approval could be significantly quicker and easier than before the COVID-19 crisis.
  • Given the many permutations of individual positions, advice should be sought as to your own particular situation before commencing manufacture.
  • This position is as at 1 April 2020 and is subject to change as the regulatory position in relation to the COVID-19 pandemic develops.

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