Last Updated on January 20, 2023
The applications for Drug Manufacturing Licenses for pharmaceutical and biological drugs are reviewed and evaluated by the Division of Drug Licensing. The application evaluation process flows and process descriptions for Drug Manufacturing License and its renewal are provided below:
Drug Manufacturing License
The process of Grant of Drug Manufacturing License (DML) is a 3 steps procedure;
Step I: Verification of Proposed Manufacturing Site:-
Application for verification of proposed manufacturing site shall be submitted by the applicant with supporting documents (as per checklist) and applicable fee. The evaluation process flow and process description are being provided for illustrative purpose.
Step II: Approval of Layout plan of Proposed Site:-
Application for Layout Plan Approval shall be submitted by the applicant along with requisite documents (as per checklist) and applicable fee. The evaluation process flow and process description are provided for illustrative purpose.
Step III: Grant of Drug Manufacturing License (DML):-
Application for grant of Drug Manufacturing License (DML) shall be submitted by the applicant on Form 1 with supporting documents and applicable fee. The evaluation process flow and process description are provided for illustration.
Renewal of Drug Manufacturing License:-
Application for renewal of Drug Manufacturing License (DML) shall be submitted by the applicant on Form 1-A with supporting documents and applicable fee. The evaluation process flow and process description are provided for illustration.