Industry
UCMPMD approval for HCP foreign advanced clinical training
Get professional support in obtaining Department of Pharmaceuticals (DoP) approval for conducting foreign training events under the Uniform Code for Medical Devices Marketing Practices, 2024 (UCMPMD).
Overview
DoP approval is mandatory for any medical device company wishing to organize any advanced clinical training for healthcare professionals (HCPs) outside India. The approval is granted only under exceptional circumstances, such as the unavailability of trainers, equipment, or products in India. The application is required submitted in the prescribed format with supporting documents containing justification, list of participating HCPs, training duration and location, trainer and facility details, and a comprehensive expenditure breakdown.
Services
We provide end-to-end services for obtaining DoP approval, which includes:
- DoP approval requirement assessment
- DoP approval eligibility
- Application review
- Justification review
- Ongoing compliance and query resolution support
- Resubmission of application in the event of rejection
Process
There are generally five steps to obtaining an import license.
- 1
Information collation
Collation of relevant information including names of participants, trainers, facility, itinerary etc.
- 2
Review
Review of justification to conduct training at a foreign location
- 3
Submission
Submission of application form to DoP
- 4
Query resolution
Response to the queries raised by DoP (if any).
- 5
Approval
Grant of DoP approval to conduct clinical trainings
Timeline
The application for approval for foreign advanced clinical training must be submitted at least 3 months in advance from the scheduled date of the clinical training.
Validity
Each DoP approval is valid only for one advanced clinical training event.
Key documents required
- Duly filled approval form
- Justification for foreign location
- List of participating HCPs
- Duration and exact location of training
- Details of trainers, equipment, and facilities
- Complete expenditure breakdown (travel, boarding, etc.)
Fees
No government fee is applicable for application for DoP approval.