Medicine and Health Product License Renewal Request

This service is provided by the National Health Regulatory Authority to Businesses requesting to renew the medicine licenses and to provide an opportunity for the Authority to conduct a periodic review to ensure that the benefits of licensed medicines outweigh any known risks.

group_work   Available Channels

Contact Information

eKiosks

Mobile Applications

Service Location

   Service Terms

  • Target User Group:
  • Business ,

   Required Documents

  1. Request Letter
  2. Medicine/health product renewal application forms
  3. Copy of the product license
  4. Copy of the National Health Regulatory Authority license for the health product shop
  5. List of the approved variations since the time of the last renewal/medicine information registration
  6. CPP (in WHO format) attested from the Chief Operations Officer COO (batch releaser)
  7. Summary of the product specifications for medicines
  8. Mock-ups of outer label, inner label and package leaflet
  9. Approved finished product specification
  10. Method of analysis for the finished health product
  11. Flow chart showing the details of all the manufacturers involved in all the manufacturing steps (active substance, intermediate and finished product) for health product
  12. Copy of the manufacturer registration certificate in Bahrain
  13. Valid GMP certificate issued from the health authority (attested) for health products.
  14. Valid manufacturing license issued from an official authority if the requirements above are unavailable for health products
  15. Stability data to support the approved shelf-life according to the GCC stability guidelines
  16. Contact details of the authorised marketing representative responsible for the communication with the NHRA regarding quality issues for medicines
  17. A quality overview for the medicine, dated and signed by an expert
  18. Price declaration showing for example: factory price, whole sale and public retail price in the country of origin
  19. Composition certificate clearly stating the strength, source and function of every ingredient for health products
  20. If the active ingredient is not completely described, the manufacturing process, method of analysis and validation is required for the health product
  21. Worldwide registration status – registered, marketed (date), under registration, or rejected (reason)for Health product
  22. Heavy Metals, microbial and pesticide tests for herbal products
  23. TSE/BSE free certificate for health products
  24. Alcohol content declaration for health products
  25. Pork content declaration for health products
  26. Proof of payment

   Important notes

  • Readiness:
  1. The pharmaceutical products should be registered with the National Health Regulatory Authority
  2. Valid manufacturing site registration certificate from the National Health Regulatory Authority
  3. Valid National Health Regulatory Authority license for the health product shop
  • Others:
The applications should be submitted six months before the expiry date of the license to ensure that the assessment is completed before the date of expiry

   Payment

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