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The ‘sunset clause’

28 th Feb The ‘sunset clause’

Keep careful track of a product authorisation date, as the UK marketing authorisation of a medicinal product, will cease to be valid if:

– the medicinal product is not placed on the market within three years of the authorisation being granted or,

– where a medicinal product previously placed on the market is no longer actually present on the market for three consecutive years.

The MHRA may grant exemptions on public health grounds and in exceptional circumstances if duly justified. Read more from the MHRA here.


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