[Regulation 3 Heading substituted by Amendment Notice No. 4793, GG50642, dated 10 May 2024]
Despite regulation 2, the following activities do not qualify as scientific or technological research and development in respect of clinical trials being carried on for the purposes of section 11D of the Act:
[Words preceding paragraph (a) substituted by Amendment Notice No. 4793, GG50642, dated 10 May 2024]
| (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. |
Financial Sector Regulation Act, 2017
