Are you aware of  new European Nitrosamine Regulations – EMA/511347/2019.  There is serious workload expected from all marketing authorisation holders (MAH) in EU! Let’s see what is expected for MAH compliance related to nitrosamines.

On 26 September 2019, the EMA published a statement titled “EMA advises companies on steps to take to avoid nitrosamines in human medicines (EMA/511347/2019)“. With regard to the Art. 5(3) referral, MAHs are requested to evaluate the risk of the presence of nitrosamine impurities in their human medicinal products containing chemically synthesized active pharmaceutical ingredients (“Information on nitrosamines for marketing authorisation holders:”).

All marketing authorisation holders, who are ultimately responsible for the quality, safety and efficacy of a medicinal product should conduct a risk evaluation regarding potential nitrosamine contamination in 3 sequential steps:

Step 1: Risk evaluation
Step 2: Confirmatory testing
Step 3: Changes to the marketing authorisation

Marketing authorisation holders should start from Step 1 and conduct a risk evaluation to identify products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome by 26 March 2020 at the latest.

The outcome of the risk evaluation, even if no risk has been identified, must be submitted using the relevant templates for each medicinal product to all national competent authorities where the respective product is authorized as soon as the individual risk assessment is finalized.

The outcome of the confirmatory testing must be sent even if it results in „no nitrosamine detected“ or immediately after detection, through the dedicated email addresses and procedures, to the concerned national competent authorities in case of purely national MAs, to the RMS in case of MRP/DCP products (copying the CMS’s) or to the EMA in case of CAPs including „Outcome of confirmatory testing nitrosamines – Step 2“ in the heading. Templates are available on CMDh website at the following link

National competent authorities have set up dedicated e-mail addresses and, in some cases specific regulatory procedures to submit the outcome of the risk assessment for nationally authorised products (including MRP and DCP).

All authorised human medicinal products containing chemically synthesized APIs are to be reviewed, including generics and over the counter (OTC) products.

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