Information on nitrosamines for marketing authorisation holders
The European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) as described in information on nitrosamines for marketing authorisation holders (see below) to 1 October 2020.
This follows reports of the challenges encountered in meeting the original deadline of 26 March 2020, and the impact of the severe restrictions in place to combat the COVID-19 pandemic.
The European medicines regulatory network encourages marketing authorisation holders to submit the outcome of step 1 before 1 October 2020 if they complete the risk evaluation or identify a risk in their products.
MAHs are reminded that:
- The outcome of step 1 is a comprehensive risk evaluation of active pharmaceutical ingredients (APIs) and finished products (FPs).
- The step 1 response template should already be used if a risk has been identified for the API. In this case, the MAH is advised to proceed directly with step 2 confirmatory testing of the finished product.
- If a risk is not identified in an API, the MAH is advised to proceed with the risk evaluation of the FP and submit the outcome of step 1 only when a final conclusion is reached on the API and FP.
- It is acceptable for the submission of the outcome of step 1 to submit one email notification grouping products with identical outcome, additional national provisions e.g. Mandatory use of portals have to be followed. Additional instructions on this point will be provided in Q&A 5.
MAHs should inform the competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected. The immediate risk to patients should be assessed and appropriate action taken to avoid or minimise the exposure of patients to nitrosamines.
- Information to marketing authorisation holders (26 September 2019)
- Questions and answers on “Information on nitrosamines for marketing authorisation holders” (March 2020)
- CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines (March 2020) [Tracked]
- Step 1: response - no risk identified;
- Step 1: response - risk identified (doc);
- Step 1: response - risk identified (xls);
- Step 2: response - no nitrosamine detected;
- Step 2: response - nitrosamine detected (doc);
- Step 2: response - nitrosamine detected (xls);