59. Application for Registration of a medicine

The Authority shall maintain a register in which every application received for the registration of a medicine shall be recorded.

The particulars to be entered in such register shall be as prescribed.

to the MEC, for the evaluation of the application and the medicine considering the need to ensure the availability of efficacious, safe and good quality medicine relevant to the healthcare needs of the public at an affordable price; and

to the NMQAL, for testing of the quality of the medicine.

setting out the procedures to be followed, by the MEC and the NMQAL in their respective evaluation and testing processes;

specifying –

the time-limits in conducting such testing or evaluation;

the manner in which the MEC to conduct its meetings and the procedure to be followed at such meetings; and

the matters which should be included in the reports to be submitted.

The Authority may require the MEC and the

The MEC and the NMQAL shall within the time limits specified submit their reports to the Authority unless there are compelling reasons for any delay.