Medicine and Health Product Registration Request

This service is provided by the National Health Regulatory Authority to Businesses requesting to register medicines and health products to ensure that the pharmaceutical products registered in the Kingdom of Bahrain are consistent with the current medical and scientific specifications, quality, safety and efficiency of pharmaceutical products.

group_work   Available Channels

Contact Information

eKiosks

Mobile Applications

Service Location

   Service Terms

  • Target User Group:
  • Business ,

   Required Documents

  1. Request Letter
  2. technical documents for medicines
  3. Medicine licensing -health product application form
  4. Medicine licensing check list signed and stamped by an authorized person
  5. Pricing form signed and stamped by an authorized person
  6. Summary of the product characteristics (SOPC) declaration
  7. Label text (immediate and secondary packaging)
  8. Package leaflet (English and Arabic)
  9. Artwork (mock-ups of outer and inner pack and package leaflet)
  10. One finished product sample
  11. Contact details of the authorized marketing representative responsible for the communication with the NHRA regarding quality issues for medicines
  12. Patency information for medicines
  13. Certificate of Pharmaceutical Product (CPP) according to the WHO format attested by the country that produced the medicine
  14. Good manufacturing practice (GMP) compliance certificates or proof of inspection by a recognized CA for all manufacturer(s) for API manufacturer(s) legalized GMP for medicines
  15. Certificate of suitability for the active substance, if available for medicines
  16. Certificate of suitability for TSE for medicines
  17. Certificate of analysis for the drug substances from the supplier of the medicines
  18. Certificate of analysis for the finished product
  19. Price Certificate showing for example: factory price, whole sale and public retail price in the country of origin (attested and issued within the last six months from the submission date) for medicines
  20. Manufacturer registration certificate in Bahrain (batch releaser) for medicines
  21. Copy of NHRA license for the health product shop
  22. Worldwide registration status (registered, marketed (date), under registration and rejected)
  23. Contact details of the authorized person regarding quality
  24. Patent information
  25. Relevant certificates such as CPP, GMP and Price Certificate for health products
  26. Alcohol content declaration
  27. Pork content declaration
  28. Composition certificate clearly showing the strength, source and function of each ingredient of the health product
  29. If the active ingredient is not completely described, the manufacturing process, method of analysis and validation is required for the health product
  30. Flow chart showing the details of the manufacturers involved in all the manufacturing steps (active substance, intermediate and finished product) for health product
  31. Stability data or justification from the company if not available for the health product
  32. Heavy Metals, microbial and pesticide tests for herbal products
  33. TSE/BSE Free Certificate for health product
  34. Global Registration Status
  35. Proof of Payment

   Important notes

  • Readiness:
  1. Valid Manufacturer Licenseissued by the National Health Regulatory Authority
  2. Valid Health Product Shop license issued by theNational Health Regulatory Authority

   Payment

  • Payment Methods:
  • Cash ,
  • Service Fees:
  • BD 5