The EDQM recognises that due to the impact of the global outbreak of COVID-19, many CEP holders are encountering significant challenges in completing the work within the timelines previously announced in the EDQM request to CEP holders to perform a risk evaluation of their chemically synthesised APIs with regards nitrosamine formation, published on the EDQM Website (EDQM request October 2019).
The EDQM is therefore granting an extension as follows:
Step 1 - Risk Assessments:
- to be completed at the latest by 31 July 2020, but expected as soon as possible when a risk is identified
Step 2 - Confirmatory Testing and Step 3 - Changes to CEP (as required):
- to be completed by 26 September 2022 or at an earlier time, if otherwise justified (no change).
CEP holders will be aware that the European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) for marketing authorisation holders to 1 October 2020. EDQM has chosen the extended deadline for CEPs in advance of this date to ensure that information on drug substances which are subject of CEPs is available in a timely manner to allow for marketing authorisation holders to meet the extended deadline for their medicinal products.