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) |
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; |
(b) |
post-marketing research; |
(c) |
cost-effectiveness research; |
(d) |
an activity undertaken solely for the purpose of compliance with regulatory requirements; |
(e) |
a product familiarisation program; |
(f) |
research carried on for statistical purposes (meta-analysis); |
(g) |
epidemiological research; or |
(h) |
research activities undertaken in preparation for the registration of a clinical trial. |