Nitrosamines Safety Operational Expert Group

The Nitrosamines Safety Operational Expert Group (NS OEG) supports the operational work of the Non-clinical Working Party related to the risk assessment of nitrosamines.

It is established under the Committee for Medicinal Products for Human Use (CHMP) and the Non-clinical Working Party (NcWP).

Role

The group’s tasks include:

• Supporting the Non-clinical working party with answering queries about issues related to nitrosamine impurities
• Harmonising the establishment and assessment of the acceptable intake limit for nitrosamine impurities in the EU
• Liaising with international regulators to seek international harmonisation and facilitate regulatory convergence

Mandate and rules of procedure

Information on the group's mandate, objectives and rules of procedure is available below:

Provisional mandate, objectives and rules of procedure for the Nitrosamines Safety Operational Experts Group (NS OEG)

Reference Number: EMA/425517/2022

Composition

The group is composed of European experts nominated by the CHMP, taking into consideration the best available expertise needed to deliver its commitments.

The current members are listed below, in alphabetical order of surname. Their declarations of interests are available in the European expert list:

• European experts