Rule 4
Product License To Be Obtained To Manufacture Drug
(1) A person who has already established a drug industry after having obtained the recommendation letter pursuant to Sub-rule (2) of rule (3) or a person who has already established a drug industry prior to the commencement of this Act shall make an application to the Department in the format as referred to in Schedule-3 to obtain the product
license to manufacture the drug pursuant to section 8 of the Act.
(2) After an application is made pursuant to Sub-rule (1), the Department shall make necessary inquiry into the matter and register such drug in the registration book in the format as referred to in Schedule-4 and issue the
production license to the applicant in the format as referred to in Schedule-5 by collecting the fees as prescribed in Schedule-14.
license to manufacture the drug pursuant to section 8 of the Act.
(2) After an application is made pursuant to Sub-rule (1), the Department shall make necessary inquiry into the matter and register such drug in the registration book in the format as referred to in Schedule-4 and issue the
production license to the applicant in the format as referred to in Schedule-5 by collecting the fees as prescribed in Schedule-14.