(1) According to sub-rule (2) of rule 3, a person who has established an industry or a person who has established a pharmaceutical industry before the commencement of the Act may obtain a product for manufacturing medicine according to section 8 of the Act. To get a license, an application should be submitted to the department in the format as per schedule-3.

(2) After receiving the application as per sub-rule (1), the department shall carry out the necessary checks and register such medicine in the registration book in the format as per schedule-4 and as specified in schedule-14 After receiving the document, the production license will be given to the applicant in the format as per Schedule-5.