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NHRA Medicine Registration

Application Documents

Completed application form

Copy of medical license

Copy of DEA registration

Curriculum vitae

List of publications

Drug Information

Brand name of medicine

Generic name of medicine

Dosage form

Strength

Manufacturer information

Clinical Data

Indications

Contraindications

Adverse reactions

Drug interactions

Clinical trials data

Labeling Information

Package insert

Patient information leaflet

Labeling for container

Dosage and administration instructions

Storage and handling instructions

Quality Control

Certificate of analysis

Stability data

Manufacturing process

Batch records

Quality assurance procedures

Regulatory Compliance

Proof of GMP compliance

Regulatory approvals in other countries

Compliance with NHRA regulations

Any additional regulatory documents

Final Review

Review all documents for accuracy and completeness

Ensure all required information is included

Double-check for any missing or incomplete sections

Submit completed checklist and documents to NHRA for review and approval.

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