Service Directory
International Pharmaceutical Manufacturing site renewal
This service allows registered local agents and distributors of medicine to renew NHRA licenses for international manufacturing sites, ensuring that these facilities maintain compliance with quality, safety, and national health regulations. A valid Manufacturer License is required for all medicines registered in Bahrain, and a site license—renewed every five years—is mandatory before submitting any new product registration or site-related variation. Applications are submitted through the Adweya Portal.
Service Conditions
- It is the responsibility of the applicant to ensure that all the information given in the approval checklist and supporting documents are true and valid.
- The application should clearly indicate the activities conducted at the manufacturer's site.
Required Attachments
- International Manufacturing Site Licensing Procedure , View Document
Legal Regulations
- Law No. (63) of 2019 on issuing requirements and procedures for the practice of the pharmaceutical profession and the licensing of pharmaceutical centers, factories and facilities.
- Decree-Law No. (18) of 1997 regulating the profession of pharmacy and pharmaceutical centres
Process Time
- 30 Working Days : For the online requests
Service Provider
National Health Regulatory Authority
Cooperative Entities
- Ministry of Health
