Frequently Asked Questions (FAQs) on Drug-Medical Device Combination Products
FAQs: Variation On Medical Device-Drug Combination Products
Variation procedure for a registered combination product
Kindly refer to 6.0 Post Approval Changes/ Variation To Particulars Of A Registered Combination Product, Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products available at here.
Variation application should be submitted along with a cover letter which includes the following:
- Brief description of the proposed variation with justification
- Current and proposed change of information in tabulated format
- A declaration which is undersigned by the Product Registration Holder that declares:
- There is no other change except for the proposed variation;
- The required supporting documents as specified for the variation have been submitted; and
- All of the conditions have been fulfilled based on the proposed category
Where shall the applicant submit the required documents?
What are the documents required to be submitted for additional/ replacement of the manufacturing site of drug substance?
What are the documents required to be submitted for Change of specification of drug substance?
What is the validity period of the endorsement letter issued for variation of a particular ancillary component?
