Conditional Marketing Authorisations, Exceptional Circumstances Marketing Authorisations and National Scientific Advice from 1 January 2021.

The MHRA will introduce a national Conditional Marketing Authorisation (CMA) scheme from 1 January 2021. The scheme will have the same eligibility criteria as the EU scheme. It is intended for medicinal products that fulfill an unmet medical need.

The final decision on eligibility of a product for the Great Britain scheme will rest with the MHRA.  CMAs will be valid for one (1) year and will be renewable annually. The MHRA is likely to impose specific obligations on the holder of a Marketing Authorisation that is approved under exceptional circumstances.

The MHRA will continue to offer its national scientific advice service after 1 January 2021. This service is available for developers of medicinal products and can be requested at any stage of the product's development. From 1 January 2021 there will be a change to the fees payable for scientific advice.

Source: MHRA guideline on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021.


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