Service Directory

International Pharmaceutical Manufacturing site new registration

Licensing of international manufacturing sites with the National Health Regulatory Authority (NHRA) is a mandatory requirement that must be fulfilled prior to the submission of any application for new product registration or a variation application involving a relevant site transfer. This ensures that all manufacturing facilities involved in the production of pharmaceutical products meet the regulatory standards set by the NHRA, thereby upholding product quality, safety, and compliance with national health regulations. the applications are submitted on Adweya Portal.

Service Conditions

  • Kindly refer to the link below https://www.nhra.bh/Departments/PPR/MediaHandler/GenericHandler/documents/departments/PPR/International%20Manufacturing/PPR_Procedure_International%20Manufacturing%20Site%20Licensing%20Procedure%20V1.5_20230611.pdf
  • The applicant to ensure that all the information given in the approval checklist and supporting documents are true and valid.

Required Attachments

  • International Manufacturing Site Licensing Procedure , View Document

Legal Regulations

  • Decree-Law No. (18) of 1997 regulating the pharmacy profession and pharmaceutical centres
  • Decision No. 63 of 2019 issuing a regulation of the requirements and procedures for practicing the profession of pharmacy and licensing pharmacy centers, pharmaceutical factories, pharmaceutical products, and pharmaceutical facilities

Fees

  • 50 : Application Fees

Payment Methods

  • Electronic

Process Time

  • 30 Working Days : For the online requests

Service Provider

National Health Regulatory Authority

Service Processes

  • Submit the application using the Adweya portal with all the required document according to the below link https://www.nhra.bh/Departments/PPR/MediaHandler/GenericHandler/documents/departments/PPR/International%20Manufacturing/PPR_Procedure_International%20Manufacturing%20Site%20Licensing%20Procedure%20V1.5_20230611.pdf
  • The assessor reviews the submitted documents and, if they comply, approves the international manufacturers site Registration application
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