Japan - Partial amendment to the Minimum Requirements for Radiopharmaceuticals

Ministry of Health, Labour and Welfare has issued notification on partial amendment to the Minimum Requirements for Radiopharmaceuticals. The Minimum Requirements for Radiopharmaceuticals are tobe partially amended to add the standards for a radiopharmaceutical to be newly approved.

Proposed date of adoption: The same day as the approval of the radiopharmaceutical

Proposed date of entry into force: The same day as the approval of the radiopharmaceutical

Final date for comments: 20 October 2016

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures before 20 February 2016, so that these can be taken up suitably.