Nitrosamines in medicinal products: templates and web forms for submitting the results of confirmatory tests

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

STEP 2 - Confirmatory tests

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.

Further information

Contact
postlicensing@fagg.be

Last updated on
02/07/2020