Medicine Registration Renewal
This service allows medicine license holders to apply for the renewal of an existing medicine registration issued by the National Health Regulatory Authority (NHRA), to ensure the continued marketing of medicines in the Kingdom of Bahrain after registration expiry. Through this service, applicants can submit all required documents and pay the applicable fees electronically via the Adweya system. The NHRA reviews the application to ensure compliance with quality, safety, efficacy, and regulatory requirements. Upon completion of the review and payment of the prescribed fees, a renewed medicine registration will be issued with a validity of five years. The service aims to ensure the continuity of registered medicines in the market, protect consumer health, and promote compliance with regulatory standards.
Service Conditions
- A complete application should be submitted with all the required documents.
Required Attachments
- a full eCTD (m1 to m5) at least full M1 and M3 should be submitted. , 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
- Decree-Law No. (20) of 2015 amending some provisions of Decree-Law No. (18) of 1997
Fees
- 100 : Medicine Renewal
Process Time
- 25 Working Days
Service Provider
National Health Regulatory Authority
Cooperative Entities
- Ministry of Health
Service Processes
- Submit a complete medicine license renewal application through the Adweya system via: https://adweya.nhra.bh.
- Review of the application by the National Health Regulatory Authority to verify compliance with all quality, safety, efficacy, and regulatory requirements.
- Issuance of approval upon completion of the review and payment of the prescribed fees, with the renewed license valid for five year.
