UK MHRA’s International Recognition Procedure Does Not Guarantee OTC Status

 Under its new International Recognition Procedure, approval by one of the MHRA's seven “reference regulators” – including the US FDA – as an OTC medicine does not necessarily mean the same status will be granted in post-Brexit UK, warns regulatory consultancy JensonR+.

union jack flag and iconic Big Ben at the palace of Westminster, London - the UK prepares for new elections - Image
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As of 1 January 2024, manufacturers of OTC medicines approved by regulators in seven countries will be able to access a quicker approval process for these products in the UK.

However, OTC status granted by one of these “reference regulators” – Australia (TGA), Canada (Health Canada), Switzerland (SwissMedic), Singapore (HAS),...

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