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Parliamentary questions
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20 August 2018
E-003730/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-003730/2018

The issue of the contamination of certain medicines with N-Nitrosodimethylamine (NDMA) is a serious concern. On 5 July 2018 the Commission triggered a review (commonly called referral) of valsartan medicines in relation to NDMA found in the active substance from Zhejiang Huahai Pharmaceuticals. The review is being carried out by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) which will adopt the Agency’s opinion(1). The CHMP opinion will be sent to the Commission for a final legally binding decision applicable in all EU Member States concerning whether marketing authorisations of the medicines under review should be maintained, varied, suspended or revoked. In the meantime, as a precaution, Member States are recalling the concerned medicines.

The European Directorate for the Quality of Medicines and HealthCare (EDQM) is responsible for the certification of suitability to the monographs of the European Pharmacopoeia (CEP procedure) for pharmaceutical substances. The EDQM does not change the manufacturing process for active substances. It is the manufacturer who introduces such changes, validates them and submits them for approval. The EDQM has strict procedures for the evaluation of dossiers submitted to obtain a CEP and relies on the expertise of experienced quality assessors nominated by competent authorities for their evaluation.

The risk of the presence of the NDMA impurity in other sartans (the class of active substances) is being assessed by the EDQM for those active substances covered by CEPs, and the holders of these CEPs have been contacted by EDQM. National competent authorities and the EMA are being regularly updated on progress of this review by the EDQM, which should be completed soon.

(1)Information on the CHMP review is available on the EMA website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valsartan_containing_medicinal_products/human_referral_000434.jsp&mid=WC0b01ac05805c516f.

Last updated: 21 August 2018Legal notice