Application for registration of bioavailability and bioequivalence study centre
Application for registration of any bioavailability and bioequivalence study centre with the Central Licencing Authority shall be made to the said authority in Form CT-08.
The application under sub-rule (1) shall be accompanied by a fee as specified in the Sixth Schedule and such other information and documents as specified in the Fourth Schedule.
Grant of registration to bioavailability and bioequivalence study centre:
The Central Licencing Authority may, after scrutiny of the information and Documents furnished with the application in Form CT-08 and such further enquiry, if any, as may be considered necessary, and if satisfied, that the requirements of these rules have been complied with, grant registration to the applicant in Form CT-09 within a period of ninety working days from the date of receipt of its application in Form CT-08; or if not satisfied, reject the application, for reasons to be recorded in writing, from the date the application was made under sub-rule (1) of rule 45.
Validity period and renewal of registration:
The registration granted under rule 47 in Form CT-09 shall remain valid for a period of five years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority.
The bioavailability or bioequivalence centre shall make an application for renewal of registration in Form CT-08 along with documents as specified in the Fourth Schedule at least ninety days prior to date of expiry of its registration:
The Central Licencing Authority shall, after scrutiny of information enclosed with the application and after taking into account the inspection report, and such further enquiry, if any, as may be considered necessary, if satisfied, that the requirements of these rules,—
have been complied with, grant registration or renew registration in Form CT-09;
have not been complied with, reject the application, for reasons to be recorded in writing, within a period of forty-five days, from the date the application
