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 must be reported via the particular web form, before 31 March 2021 for chemical medicinal products and before 1 July 2021 for biological medicinal products. MA (marketing authorisation) variations must be submitted before 26 September 2022 (chemical medicinal products) and before 1 July 2023 (biological medicinal products).
In June 2020, the EMA finalised a review under Article 5(3) of Regulation (EC) No 726/2004 on the prevention of impurities caused by nitrosamines in medicinal products for human use. As a consequence, risk assessments must take place for all authorised biological medicinal products for human use or medicinal products for human use containing chemically synthesised active substances, regardless of the authorisation procedure. The EMA has published a questions and answers document on this subject.
Report risk assessments and the results of confirmatory tests 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 (step 1) and the results of confirmatory tests (step 2) 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.
Submit MA variations
STEP 3 - MA adaptation
Submit all variations necessary to adapt the MA before 26 September 2022 for chemical medicinal products and before 1 July 2023 for biological medicinal products.
In order to meet these deadlines, the confirmatory tests (step 2) must be carried out sufficiently in advance.
- FAMHP News Report 02.10.2019
- FAMHP News Report 30.03.2020
- FAMHP News Report 02.07.2020
- CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines