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Parliamentary questions
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13 November 2019
Question for written answer E-003830/2019
to the Commission
Rule 138
Tonino Picula (S&D)
 Answer in writing 
 Subject: Medicines containing carcinogenic substances

The European Medicines Agency (EMA) recently launched an assessment of medicines that contain the active substance Ranitidine after studies showed that some of these medicines were contaminated with N-nitrosodimethylamine (NDMA).

NDMA and its related substances are believed to be carcinogenic to humans and were found last year in some medicines that lower high blood pressure (‘sartans’), leading to the withdrawal of some medicines and, eventually, to the establishment of strict new production requirements.

Thousands of Croatian and European citizens are using anti-heartburn medicines containing Ranitidine every day. Some of these medicines have already been withdrawn from pharmacies in the USA, and the same is happening in EU Member States. These medicines are currently being withdrawn in 13 Member States.

1. Given that these medicines are available on the market without a prescription and are used daily by thousands of people, what measures does the Commission plan to take in order to protect the rights of the consumers who have used that medicine for years, as well as to penalise the companies which put them on the market, in view of the latest evidence of their potential harm to health?

2. What additional measures does the Commission plan to take to prevent similar situations arising in the future and make it impossible for medical products that are potentially dangerous to public health to be sold?

Original language of question: HR
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