Despite regulation 2, the following activities do not qualify as research and development in respect of clinical trials being carried on for the purposes of section 11D of the Act:
||a phase IV clinical trial, as defined in Appendix F to the Guidelines other than a clinical trial conducted for the purpose of developing new indications, developing new methods of administration or developing new combinations of pharmaceutical products;
||an activity undertaken solely for the purpose of compliance with regulatory requirements;
||a product familiarisation program;
||research carried on for statistical purposes (meta-analysis);
||epidemiological research; or
||research activities undertaken in preparation for the registration of a clinical trial.