Regulations Governing Management of Infectious Biological Materials Article 17

The possession, storage, use, disposition or transfer of pathogens in Risk Groups 2-4 or biotoxins must be reviewed and approved by the BSO, and in addition, reviewed and approved by the IBC if the entity has an IBC set up.Where the pathogens or biotoxins in the preceding paragraph are BSAT, their possession, storage, use, disposition or transfer must be reviewed and approved by the BSAT officer and the IBC, and those activities can only be performed at controlled premises whose inauguration has been approved by the central competent authority.The possession, storage, new addition or transfer of pathogens mentioned in Paragraph 1 hereof that are classified in Risk Groups 3 or 4, or BSAT mentioned in the preceding paragraph shall not commence until the entity has reported to and obtained approval from the central competent authority; when the entity removes an above-mentioned infectious biological material from its inventory, it shall report it to the central competent authority for record within thirty days following the removal.Regarding the transfer mentioned in Paragraph 1 and Paragraph 2 hereof, the recipient must be an entity that has already reported to and obtained approval from the competent authority according to Paragraph 2 or 3 of Article 9 herein, and the transfer has been reviewed and approved by its IBC prior to receipt.The recipient of transferred BSAT shall, within three days from the day following the receipt of BSAT, report the receipt to the central competent authority for record.