Import Restrictions for some Products from Japan

In 2011, the Fukushima Daiichi nuclear power plant was severely damaged after the Tsunami tragedy, followed by a radiation leak. Since that, European regulatory authorities have been working with international regulatory partners to ensure that appropriate measures are taken to monitor food and pharmaceutical products coming from Japan.

In the CMDh paper "Monitoring of medicines originating from Japan" it is stated that "to date, no risks from radioactive contamination have been identified in any medicines imported to the European Union (EU) and the likelihood of such contamination occurring is considered to be minimal." However in the interest of patient safety, the CMD(h) has issued the regulation (EU) 322/2014 defining measures to be put in place in the EU for food and animal feed.

As a consequence, the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMD(h)) (part of the Heads of Medicines Agencies) has now revised its document defining restrictions for medicinal products from certain areas in Japan. The following measures listed apply to all medicines "manufactured, partially manufactured, transited or stored in Japan with the exclusion of products" which have been manufactured after March 2011:

• "For medicines manufactured, partially manufactured, transited or stored in the prefecture of Fukushima, testing for the presence of radioactivity is still required."
• "For medicines manufactured, partially manufactured, transited or stored in the prefectures of Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Iwate, and Chiba and Kanagawa, testing is only required for medicinal products containing raw materials of fish, animal or vegetal origin sourced from these prefectures."
• "For medicines manufactured, partially manufactured, transited or stored in other Japanese prefectures, no additional testing for the presence of radioactivity is required."
• "Testing of cytotoxic products irrespective of origin is not requested in view of the potential risks to the operators and the minimal likelihood of radioactive contamination as confirmed by the data available to date."
• "European Regulatory Authorities have, in addition, decided that medicines coming from manufacturing sites in any of the listed prefectures where satisfactory test results have been recorded are no longer requested to be tested."

As with the food measures, the approach is expected to be applicable until 31 March 2015 and will be reviewed again at that time.

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h), has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The CMD(h) has started its activities in November 2005 and replaced the informal Mutual Recognition Facilitation Group, which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.