Pharmaceutical Manufacturer Registration Request

This service is provided by the National Health Regulatory Authority to Businesses requesting to register a Pharmaceutical Manufacturer to produce locally and import pharmaceutical products to the Kingdom of Bahrain.

group_work   Available Channels

Contact Information

eKiosks

Mobile Applications

Service Location

   Service Terms

  • Target User Group:
  • Business ,

   Required Documents

 

  1. Cover letter signed and stamped from the local agent in Bahrain
  2. Letter from the company indicating the name and address of the manufacturing site and stating the relation between them
  3. Letter from the company declaring the name of the medicine’s release from this site
  4. Manufacturing Site Registration/Renewal Form
  5. Copy of a valid GCC Central or SFDA manufacturing site registration certificate
  6. Letter from the company confirming that the submitted site is responsible for the final release and if there is another site involved in the actual release it must be mentioned
  7. Copy of a valid Manufacturing License
  8. Copy of a valid Good Manufacturing Practice certificate issued by the Health Authority in the country of origin
  9. Application fee payment receipt

 

   Important notes

  • Readiness:
  1. Valid Manufacturer License issued by the National Health Regulatory Authority
  2. Valid Manufacturing Practice Certificate

   Payment

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