The European medicines regulatory network has agreed to extend the deadline for submissions related to Step 3: variation to the marketing authorisation until 1 October 2023. This extension is intended to allow companies time to perform a thorough investigation and establish any required risk-mitigating actions. The deadline for Step 2: confirmatory testing remains unchanged: 26 September 2022.
A similar approach is being adopted for Certificates of suitability (CEPs) and therefore the previously announced deadline (“Announcement to all CEP holders for synthesised APIs regarding presence of nitrosamines”) to submit any required revisions as part of step 3 is now also extended until 1 October 2023. Nevertheless, CEP holders are encouraged to submit their requests for revision as soon as investigations are concluded and therefore in advance of the above deadline.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) reminds CEP holders that, as always, it is their responsibility to provide their customers with appropriate information related to any risk evaluations they have performed for substances covered by CEPs (“EDQM reminds CEP holders of their responsibilities towards their customers”), including nitrosamines (from step 1 – even if no risk has been identified – to step 3). This is to allow the marketing authorisation holders (MAHs) who use these CEPs to utilise this information to fulfil their own responsibilities in a timely manner, as described on the EMA website and the HMA website.