Rule 8
License To Be Obtained For Clinical Trial Of New Drug
(1) If a person intends to carry out a clinical trial of any new drug pursuant to Section 31 of the Act, such
person shall make an application to the Department in the format as referred to in Schedule-12.
(2) If, upon making necessary inquiry into the application after it is made pursuant to Sub-rule (1), the Department deems proper to issue the license to carry out the clinical trial of that new drug, it shall issue the license in the format as referred to in Schedule-13, by collecting the ? fees as prescribed in Schedule-14.
person shall make an application to the Department in the format as referred to in Schedule-12.
(2) If, upon making necessary inquiry into the application after it is made pursuant to Sub-rule (1), the Department deems proper to issue the license to carry out the clinical trial of that new drug, it shall issue the license in the format as referred to in Schedule-13, by collecting the ? fees as prescribed in Schedule-14.