64. Renewal

The holder of certificate may make an application to the Authority, for renewal of such registration or the licence six months prior to the date of expiry of such registration or the licence.

The application for renewal of registration or the licence shall be in the prescribed form and shall be accompanied by the prescribed fee.

The Authority shall, upon receiving an application, submit the application to the MEC for its opinion.

The MEC may, through the Authority, request for samples, documents or any other evidence, which it deems necessary, from the applicant or any other person or institution for the evaluation of the medicine.

The MEC may, where the MEC deems necessary, request the NMQAL to submit an evaluation report on the medicine and the NMQAL shall submit the evaluation report as required by the MEC.

The Authority may upon taking into consideration all relevant factors, renew the registration or the licence for a further period of not less than one year and not exceeding five years.