Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked all marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The result of this risk assessments (step 1) must be reported via the particular web form before 1 October 2020. Another particular web form is available for submitting the results of the confirmatory tests (step 2).
Risk assessments must take place for all authorised medicinal products for human use containing chemically synthesised active substances, regardless of the authorisation procedure. Previously, EMA published recommendations on which actions should be taken and a questions and answers document.
Report risk assessments for NPs, DCPs and MRPs to the FAMHP online
EMA and the CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures, Human) created templates to report risk assessments to the competent authorities. Send in the information regarding NPs (national procedures), DCPs (decentralised procedures) and MRPs (mutual recognition procedures) using the forms below.
STEP 1 - risk assessments
- There is no risk. Fill in the template and send it in using this web form.
- There was a risk of nitrosamine presence identified. Fill in the template and the Excel file and send in both using this web form.
STEP 2 - Confirmatory tests
- No nitrosamine detected. Fill in the template and submit it via the web form.
- Nitrosamine detected. Fill in the template and the Excel file and forward both via the web form.
Additional step for DCPs and MRPs
Please note, for DCPs and MRPs, there is an additional step to take. The completed template and the Excel file must also be sent to all affected member states.
The information on the CPs is reported directly to EMA.
- FMHP News Report 02.10.2019
- FAMHP news release 30.03.2020
- CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines