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De la EMA, que es la agencia reguladora de los medicamentos y alimentos en Europa
03/05/2011
Monitoring of products originating from Japan for the possibility of radioactivity
The European Medicines Agency is working with its European and international regulatory partners to monitor and evaluate the possible risk of radioactive contamination of medicines manufactured in Japan ***owing the radiation leak from the Fukushima Daiichi nuclear power plant.
The exchange of information with the Japanese competent authorities, the Ministry of Health, Labour and Welfare (MHLW) and the Ministry for Agriculture, Forestry and Fisheries (MAFF), as well as with other regulatory partners around the globe, has reassured the Agency that the risk to public and animal health, if any, is very small.
The Agency is taking a precautionary approach that takes into account the measures put in place in the European Union (EU) for food and animal feed.
Marketing authorisation holders (MAHs) are responsible for ensuring the continued quality, safety and efficacy of medicines.
MAHs of medicines wholly or partially manufactured in the Japanese prefectures closest to the power plant (Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Yamagata, Niigata, Nagano, Yamanashi, Saitama, Tokyo and Chiba) are asked to test their products to determine the level of the radionuclides iodine-131, caesium-134 and caesium-137 prior to export from Japan. From the information received from Japanese companies, only a small number of medicines are manufactured in these prefectures and are therefore potentially affected.
This testing is intended as an interim approach, which is likely to be revised based on experience and as initial results become available.
