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Parliamentary questions
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13 September 2018
P-004312/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: P-004312/2018

On 26 June 2018, the European medicines regulatory network consisting of national competent authorities (including Hungary), the European Medicines Agency (EMA) and the Commission were notified through the rapid alert system about the presence of the impurity N-nitrosodimethylamine (NDMA) in valsartan active substance manufactured by a Chinese supplier.

The regulatory network operates an incident management plan with the aim to take appropriate action whenever incidents which could have a serious impact on public health arise in relation to medicines. Following the Incident Review Network teleconference with EMA and Member States, on 5 July 2018 the Commission immediately initiated an EU wide review procedure of the products concerned.

The Commission asked EMA to evaluate with priority the potential impact on patients of the exposure to NDMA from valsartan medicines. The analysis of available data is ongoing.

In parallel and since the products concerned are nationally authorised medicines, the Member States have taken regulatory actions to recall affected medicines. In addition to pharmacy level recall, the Hungarian national authorities have advised patients not to stop treatment and to go to their doctor at an early opportunity so that an alternative treatment can be prescribed for them.

In addition to dealing with the consequences of the specific incident now, the Commission together with EMA and the European medicines regulatory network will study the lessons learned from this case.

Last updated: 13 September 2018Legal notice