Service Directory

Alternative and Complementary Medicine Renewal

A service through which approved alternative and complementary medical products are reviewed to ensure they continue to meet safety, efficacy, and compliance with relevant standards. This service ensures that approved alternative and complementary products maintain quality standards before they are approved.

Required Attachments

Valid Good Manufacturing Practice certificate (GMP) (legalized) (with validity of at least 3 months). (Hard copy)
Appointment sheet for product composition
Cover letter from the local agent and company. (Hard copy)
Valid pharmacy license with related activity.
Copy of NHRA approval certificate (for renewal application only).
Application form. (Hard copy)
Valid copy of manufacturing license of the manufacturer. (with validity of at least 3 months)
Valid product registration license/Free sales certificate from country of origin (legalized) (with validity of at least 3 months and must mention the date of marketing). (Hard copy)
Mock-ups of outer label, inner label and package leaflet
Product composition certificate (including exact concentration, source & function of both active ingredient and excipient).
Finished Product Specifications.
Declaration letter from the company that the product is GMO free.
Declaration letter from the company declaring the following: This product is free from hormones, heavy metals, antibiotics, steroids, pork and other animal origin derivatives, TSE and any other natural or synthetic material that have harmful effect on biochemical functions or behaviour of human beings.
Declaration for intended use.
Declaration for Alcohol content.
Certificate of analysis for Active ingredient(each) and finished product with inclusive of test for pesticides.
Description of manufacturing process.
Worldwide registration and marketing status with date of marketing
Declaration letter for contact details for the company responsible person for communication with NHRA on quality related matters.
Copy of pharmacopeia reference.
All documents to be submitted on a CD/DVD including lab file along with hard copy of documents as indicated.