How Marketing Authorisation Applications Referred Under Article 29 will be Handled from 1 January 2021

From 1 January 2021, Northern Ireland will continue to participate in referrals under Article 29. For applications where the MHRA had a positive opinion at Day 210 of a DCP or Day 90 of an MRP, a Marketing Authorisation will be granted following receipt of the national product information. No additional or different fee will be charged for applications that are completed as a national procedure having previously been referred under Article 29.

Source: MHRA guideline on How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021


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