Marketing authorisation holders (MAHs) of medicinal products containing sartans with a tetrazole group (candesartan, irbesartan, losartan, olmesartan, valsartan) are informed of the following: in the context of the call for review for the identification and mitigation of the risk of nitrosamine contamination in all medicinal products for human use, the outcomes of the confirmatory studies as part of step 2 must be submitted for all medicinal products concerned.

It should be noted that, in light of the outcome of the Article 5(3) assessment on nitrosamine impurities in medicinal products for human use, the conditions to the marketing authorisation (MA) deriving from Article 31 referral on sartans containing a tetrazole group, as subsequently amended by Commission Implementing Decision of 19 February 2019 amending Commission Implementing Decision C(2019) 2698 of 2 April 2019, must be introduced and, after completing the necessary requirements, lifted, in accordance with the procedures and timelines laid down in document "Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (February 2021)", available on the CMDh website at the following link.

Reference is made to question no. 7 of the Q&A document, concerning which variations are necessary to lift the conditions on the MA. Since it is not possible to report a step 1 'no risk” outcome, MAHs must always submit the outcome of the call for review’s step 2.

Therefore, all MAHs of medicinal products containing sartans with a tetrazole ring, who have not reported a potential risk during step 1, are invited to amend their communication by sending the appropriate template to the following address: nitrosammine@aifa.gov.it, and to submit the outcomes of the confirmatory studies (step 2) and any changes to the MA deriving from the implementation of the risk control and mitigation strategy (step 3), by 26 September 2022.

It should be noted that, by the same date, MAHs will have to submit the appropriate variations to lift the condition B referred to in the above-mentioned Commission Decision. The above documents also set out the procedures that MAHs are required to follow for submitting variations for the introduction and lifting of each single condition within the relevant deadlines.