Recall of Valsartan from European pharmacies

9.7.2018

Question for written answer E-003730-18
to the Commission
Rule 130
Soledad Cabezón Ruiz (S&D)

Valsartan is an active ingredient used for the treatment of high blood pressure either on its own or in combination with other active ingredients.

According to the International Agency for Cancer Research of the WHO, the presence of N‐Nitrosodimethylamine (NDMA), a substance that could cause cancer, has been detected.

The contamination with this ‘probable carcinogen’ is thought to be linked to changes to the manufacturing process for Valsartan authorised by the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe.

Some Member States have already begun to withdraw products containing Valsartan from pharmacies.

1. What measures is the Commission intending to take to withdraw this substance from circulation?

2. Why did the EDQM change the manufacturing process for Valsartan? Has this change affected other active ingredients?

3. What procedures does the EDQM intend to adopt in order to avoid such errors in future?