Service Directory

Health Products Registration Service

This service, provided by the National Health Regulatory Authority (NHRA), enables businesses holding a valid Health Product Shop license to submit health products for registration. The service ensures that pharmaceutical products in the Kingdom of Bahrain comply with established standards of quality, safety, and efficacy, thereby safeguarding public health. Upon completion of the regulatory assessment and payment of the prescribed fees, a health product license with a validity of 5 years will be issued. This license authorizes the holder to legally market the registered product within the Kingdom.

Service Conditions

  • Valid Health Product Shop license

Required Attachments

  • Cover letter from the local agent signed and stamped
  • Health Product application form signed and stamped from company
  • Valid Good Manufacturing Practice certificate/ Manufacturing License of the Manufacturer (Legalized) (with at least 3months validity)
  • Free sale certificate/ Product license from the country of origin (Legalized) (with at least 3months validity)
  • Composition of the product (with exact composition per serving, source and function of each ingredient)
  • Proof of marketing in COO for more than 1 year issued by regulatory authority (for new registration)
  • Declaration of alcohol content
  • Declaration of pork free content
  • Declaration of presence of heavy metals and pesticides (herbal)
  • List of manufacturers involved in manufacturing process along with their respective role.
  • Mock-ups of outer label, inner label and package leaflet (with company signed & stamped) (Bilingual)
  • Registration sample
  • Copy of valid health product shop license with CR

Legal Regulations

  • Decree-Law No. (20) of 2015 amending some provisions of Decree-Law No. (18) of 1997
  • Decree-Law No. (18) of 1997 regulating the profession of pharmacy and pharmaceutical centres

Fees

  • 50BD : Submission Fees
  • 200BD : New Registration Licensing Fees

Payment Methods

  • Debit Card
  • Credit Card
  • Benefit
  • Through the bank
  • Bank Transfer
  • Fawateer

Process Time

  • 15 Working days : for the online request

Service Provider

National Health Regulatory Authority

Service Processes

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  • Applicant Submit a complete application and pay the application fees through the NHRA system.
  • NHRA Review the application to ensure compliance with all health and safety standards.
  • License Issuance once approved and licensing fees are paid, the Health Product License is issued.
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