Article 5(3) referral on nitrosamine impurities: Deadline for submission of Step 1 risk evaluation responses — 31 March 2021

News Category: Regulatory news

Date: 09/03/2021

Marketing authorisation holders (MAHs) are reminded of the imminent deadline for submitting Step 1 risk evaluation responses for the ‘call for review’ arising from the CHMP Article 5(3) referral on nitrosamines, which is outlined on our website.

Please submit Step 1 ‘risk identified’ or ‘no risk identified’ outcome templates to by 31 March 2021 for chemical products and by 1 July 2021 for biological products.

MAHs should follow closely the practical guidance available on the CMDh website under ‘Advice from CMDh /Nitrosamine impurities’ and submit only the requested declarations, using the required templates, under the appropriate email headings. No supplementation of the Step 1 declarations with unrequested information, or revision of previous declarations from ‘risk’ to ‘no risk’ may be undertaken.

The risk evaluation documents do not have to be submitted at this point but should be available on request. Where any risk has been identified, the MAH should progress immediately to Step 2 of the call for review, i.e. confirmatory testing, and establish whether nitrosamine is detected or not in the finished product using validated analytical methods.

Further information on the development of analytical methods is available in the EMA/CMDh Q&A document for MAHs/applicants on the CHMP opinion for the Article 5(3) referral.

« Back