814.501RPOFederal Council OrdinanceJan 1, 2018Original source
Any person who prepares radiopharmaceuticals must carry out the quality controls described in the product information.
The FOPH may take samples at any time in order to determine whether the requirements specified in Article 46 are still being met. For this purpose, it may engage specialised laboratories.
The FDHA may specify requirements for the preparation and use of radiopharmaceuticals; it shall take into account national and international guidelines and the recommendations of professional bodies, in particular those issued by the European Association of Nuclear Medicine (EANM)1or the Swiss Society of Radiopharmacy/Radiopharmaceutical Chemistry (SGRRC)2.
Footnotes
These guidelines (in English) can be accessed free of charge on the EANM website atwww.eanm.org. ↩
These recommendations can be accessed free of charge on the SGRRC website atwww.sgrrc.ch. ↩
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