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Parliamentary questions
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21 February 2020
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: E-003830/2019

The Commission takes the safety of medicines and the protection of patients very seriously. The unexpected presence of N-nitrosamines in certain medicines led the Commission to request the European Medicines Agency (EMA) to review the available evidence and assess the potential impact on the safe use of these medicines.

The outcome of the review of the sartan-containing medicines was that there was a very low risk that N-nitrosamine impurities at the levels found could cause cancer in humans. The ongoing EMA review of ranitidine-containing medicines is expected to be completed by February 2020.

EMA has also started developing guidance for marketing authorisation holders on avoiding presence of nitrosamines in human medicines containing chemically synthesised active substances. EMA’s Committee for Medicinal Products for Human Use is gathering and consolidating the knowledge and expertise on this subject and is expected to provide additional advice in early 2020.

In addition, a lesson learnt exercise has been initiated. The Commission will work with the national competent authorities and EMA to follow up this exercise.

The supply of medicine has been identified as a priority for the new Commission. In this context, consideration will be given to the problem of shortages of medicines in the EU as well as enhancing the oversight of the global manufacturing chain to address the quality of active substances.

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