13Investigations and therapeutic use

#### 13 Investigations and therapeutic use (1) The following are examples of circumstances that may be specified for the purposes of paragraph 11(2)(f): (a) a competitor has returned a positive test result in relation to a sample and investigations conducted by the ASDMAC or an analytical investigative body have revealed that the positive test result is not attributable to naturally occurring levels of the substance concerned; (b) a competitor has returned a positive test result in relation to a sample and the competitor did not have an approval for the use of the drug concerned for therapeutic purposes; (c) a competitor has returned a positive test result in relation to a sample and the competitor had an approval for the use of the drug concerned for therapeutic purposes but did not comply with the conditions of that approval. (1A) In specifying a circumstance as mentioned in paragraph (1)(b) or (c), a drug testing scheme may, for example, provide that an approval for the use of a drug for therapeutic purposes only counts if it was granted: (a) by ASDMAC; or (b) by a therapeutic approval body; or (c) as a result of a review or appeal (or similar process) that relates directly or indirectly to a decision of ASDMAC or a therapeutic approval body. (2) A drug testing scheme may provide that, in the course of an investigation conducted by the ASDMAC, or an analytical investigative body, in respect of a sample provided by a competitor, the ASDMAC or the analytical investigative body, as the case may be, may ask the Agency to make to the competitor one or more further requests of the kind mentioned in paragraph 11(2)(c).