Art. 47 Preparation and quality control
1 Any person who prepares radiopharmaceuticals must carry out the quality controls described in the product information. 2The 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. 3 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)25 or the Swiss Society of Radiopharmacy/Radiopharmaceutical Chemistry (SGRRC)26. 25 These guidelines (in English) can be accessed free of charge on the EANM website at www.eanm.org. 26 These recommendations can be accessed free of charge on the SGRRC website at www.sgrrc.ch. |