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Sartans: contamination of active ingredients
2023.01.03
Active substance: valsartan | candesartan | irbesartan | losartan | olmesartan
03.01.2023 - Notice within the graduated plan procedure (“Stufenplanverfahren”)
The Federal Institute for Drugs and Medical Devices (BfArM) has withdrawn the suspension of some of axcount's marketing authorizations by decision dated December 22, 2022.
14.09.2022 - Notice within the graduated plan procedure (“Stufenplanverfahren”)
The Federal Institute for Drugs and Medical Devices (BfArM) has withdrawn the suspension of some of axcount's marketing authorizations by decision dated September 2, 2022.
08.07.2022 - Notices within the graduated plan procedure (“Stufenplanverfahren”)
The Federal Institute for Drugs and Medical Devices (BfArM) has prolonged the suspension of marketing authorizations with notices dated February 21, 2022 and June 27, 2022.
08.07.2021 - Reminder of the need to submit changes
The CMDh reminds marketing authorization holders to submit the necessary amendments to angiotensin II receptor antagonists (sartans) containing a tetrazole group, which are affected by the Art-31 referral, in order to implement the new Commission decision (EMEA/H/A-31/1471 - EC Decision 19/02/2021).
19.03.2021 - Current implementation of the new implementing decision
The Federal Institute for Drugs and Medical Devices (BfArM) implements the updated implementing decision of the European Commission C(2021)1309 of February 19, 2021, amending decision C(2019)2698 of April 02, 2019, by decision of March 11, 2021. (cf.: Community register)
13.11.2020 - CHMP aligns recommendations for sartans with those for other medicines
EMA’s human medicines committee (CHMP) has aligned recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines.
22.05.2020 - Notice within the graduated plan procedure (“Stufenplanverfahren”)
Order suspending the marketing authorisation for some drugs containing sartan in order to avoid nitrosamine-containing impurities
After hearing all marketing authorisation holders of the drugs for which the planned risk-minimising measures have not yet or not fully been implemented, the BfArM has ordered the suspension of the marketing authorisations until they have been fully implemented.
06.05.2020 - Notice within the graduated plan procedure (“Stufenplanverfahren”)
Order suspending the marketing authorisation for some drugs containing sartan in order to avoid nitrosamine-containing impurities
After hearing all marketing authorisation holders of the drugs for which the planned risk-minimising measures have not yet or not fully been implemented, the BfArM has ordered the suspension of the marketing authorisations until they have been fully implemented.
02.03.2020 - Notice within the graduated plan procedure (“Stufenplanverfahren”)
Order suspending the marketing authorisation for some drugs containing sartan in order to avoid nitrosamine-containing impurities
After hearing all marketing authorisation holders of the drugs for which the planned risk-minimising measures have not yet or not fully been implemented, the BfArM has ordered the suspension of the marketing authorisations until they have been fully implemented.
02.01.2020 - Hearing within the graduated plan procedure (“Stufenplanverfahren)”
Hearing on sartan-containing medicines with regard to the avoidance of nitrosamine-containing impurities
The BfArM has consulted all marketing authorisation holders of the medicinal products for which the planned risk-minimising measures have not yet or not fully been implemented. It is intended to suspend these marketing authorisations until they have been fully implemented.
29.04.2019 - Actualisation
The European Medicines Agency (EMA) is continuing its efforts to prevent contamination in medicinal products.
18.04.2019 - Realisation of the EU Commission's implementing decision
The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the corresponding Decision of the European Commission C(2019)2698 final of 02 April 2019 (cf. http://ec.europa.eu/health/documents/community-register/html/ho26820.htm#EndOfPage) by notification of 11 April 2019. This completes the European risk assessment procedure according to Article 31 of Directive 2001/83/EC on "Angiotensin II receptor antagonists (Sartane) containing a tetrazole group" (EMEA/H/A -31/1471). The opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency becomes legally binding.
Further information on the procedure can be found in the press release of the Coordination Group, CMDh, dated March 2019:
For medicinal products for which the marketing authorisation holder had waived the marketing authorisation, a final declaratory notification was sent out.
01.02.2019 - Expert opinion of the CHMP
The review and preparation of the opinion on certain Sartanes due to impurities of the active substances was finalised by the Committee for Medicinal Products for Human Use of the EMA (CHMP).
21.09.2018 - Extension of the process to further sartans
As part of the ongoing risk assessment procedure, drugs containing the active ingredient valsartan and other sartans are tested for NDMA and NDEA contamination by an independent Official Medicines Control Laboratory (OMCL).
17.07.2018 - Procedure started
Update to the review of valsartan-containing medicinal products after an impurity in the active substance has been detected.
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):
Current guidelines for the procedure can be found in the Questions & Answers of the Coordination Group, CMDh, dated June 2019:
On December 20, 2019, a letter was published on the CMDh and EMA homepage addressed to the marketing authorization holders of sartan-containing medicinal products. This letter refers to the Q&A document of the EMA and the CMDh. For the sartan-containing medicinal products, there is additional information on how the risk assessment and the control strategy with regard to nitrosamines should be implemented by the marketing authorization holders.
To the risk assessment procedure (available in German only)