Ordinance
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Art. 65 Time of registration
1 The registration specified in Article 64 must be performed before the clinical trial is conducted, subject to the provisions of paragraph 2. 2 Clinical trials in which the medicinal product under investigation is being administered to adult persons for the first time (Phase I clinical trials) must be registered no later than one year after the completion of the clinical trial. 3 The sponsor must update the data entered in accordance with the requirements of the registry in question, as specified in Article 64 paragraph 1, but at least once a year. |