A reminder that the Risk Evaluations for the potential for nitrosamine contamination need to be submitted by 26 March 2020.

What you need to know

The national regulatory agencies may have some differences in their requirements for submitting the outcome of Risk Evaluation information, so this should be confirmed on a country by country basis:

  • MHRA has recently updated their guidance – MAHs should complete the template letter (from CMDh guidance) for each UK licence, as well as an excel spreadsheet listing all of the MAH’s UK licences, whether a risk has been identified or not. The MHRA states that there is no requirement to provide a separate cover letter with the template and that no other spreadsheets are required by the agency at this stage. The guidance also confirms the submission category for both MHRA Portal and CESP users.
  • In Ireland, HPRA has issued additional guidance, that in cases where nitrosamines have been detected above the interim limits specified by EMA, the MAH should complete and submit a Quality Defect report, in addition to the required Risk Evaluation report.

Keeping up to date

It’s also important to remember that the Risk Evaluation task doesn’t end here. Once the first Risk Evaluation has been completed and the outcome notified to the regulatory agencies, the potential for any new nitrosamine risks should be considered as part of product lifecycle management, and revisiting the Risk Evaluation should be incorporated as part of the Change Control process.

What about Marketing Authorisation Application (MAA) Applicants?

The nitrosamine Risk Evaluation also affects new MAAs. A Risk Evaluation needs to be included at the time of initial MA submission, or it will be requested during MA assessment. Any outstanding issues would have to be addressed before the MA is approved.

If you missed our previous updates on nitrosamine contamination, you can read them here:

How can S-cubed help you?

S-cubed is working with client companies, both MAHs and API manufacturers, to review their licensed medicines and manage the required risk evaluation process. We can help with liaising with contract manufacturers, and obtaining information to complete risk evaluations.

Any Questions?

If you have any questions on this topic, please don’t hesitate to ask! You can contact us through our website (www.s-cubed-global.com), via email (info@s-cubed-global.com), and telephone (S-cubed Ltd: +44 1235 77 22 60).