Nitrosamine impurities – change to deadline for step 3 submissions

News Category: Regulatory news

Date: 04/08/2022

The CHMP and CMDh have updated the guidance applicable to the Article 5(3) nitrosamines call for review. In July 2022, they extended the deadline applicable to chemical medicinal products for the submission of step 3 variations. The deadline for completion of step 3 for these products is now 1 October 2023.

Where the submission of a step 3 variation is required, the network encourages marketing authorisation holders to submit the variation applications as soon as practicable, and in advance of the extended deadline of 1 October 2023.

This extension does not affect the deadline for the completion of step 2 confirmatory testing for chemical medicines, which remains 26 September 2022.

The HPRA has revised its Nitrosamine impurities information in line with this update.  

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