(1) Section 8A of the Act. For the purpose of sub-section (1) of the production license, before distribution of each drug produced by the industry, the following details for the registration of distribution of such drug should be corrected Schedule-4A. An application should be submitted to the department in the following format:-
(a) Product specification of manufactured drug,
(b) Analytical method of the manufactured drug and the report of the test done by the laboratory designated by the department,
(c) A sample of the manufactured medicine of the level of validity at which the price is disclosed,
(d) Other matters prescribed by the department.
(2) After conducting the necessary examination on the application received as per sub-rule (1), if it is deemed appropriate to distribute the drug mentioned in the application, the department shall register such drug and take the drug registration fee as specified in Schedule-14 for each drug and Schedule-4B. Medicine distribution registration certificate will be given in the following format.
(3) Before the commencement of this rule, every drug manufacturer who has obtained a production license according to Section 8 of the Act shall register each drug produced by him in accordance with this rule within one year from the date of commencement of this rule and obtain a drug distribution registration certificate.