HPRA update on Safety Features implementation for MaHs

News Category: Regulatory news

Date: 06/02/2019

The HPRA has taken the approach in line with CMDh recommendations (Q6), that registration of safety features is a notification system only and applicants are not required to wait until official approval is received before implementing changes. This approach is in line with the process for type IA variations, provided that no other changes are made on the mock-ups at the same time and it has no impact on the overall readability of the mock-up . Where this is the case, you do not need HPRA approval of the variation to implement the safety features.


For further information please see the CMDh clarifications document here


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