Health Product Registration Renewal
This service allows health product license holders to apply for the renewal of an existing health product registration issued by the National Health Regulatory Authority (NHRA), to ensure the continued marketing of the product in the Kingdom of Bahrain after registration expiry. Through this service, applicants can submit the required documents and pay the applicable fees electronically via the Adweya system. Applications are assessed in accordance with NHRA approved procedures to ensure continued compliance with quality, safety, and regulatory requirements. Upon completion of the regulatory assessment and payment of the prescribed fees, a renewed health product registration with a validity of five years will be issued. The service aims to ensure the continuity of registered health products in the market, protect consumer health, and promote compliance with applicable regulatory standards.
Service Conditions
- A complete application should be submitted with all the required documents.
Required Attachments
- Valid Good Manufacturing Practice certificate/ Manufacturing License of the Manufacturer (Legalized)
- Valid Free sale certificate/ Product license from the country of origin/notification from official authority in COO (Legalized)
- Mock-ups of outer label, inner label and package leaflet (with company signed & stamped) (Bilingual)
- A complete product dossier including a list of all manufacturers involved and their respective roles in the manufacturing process, a declaration of alcohol and pork content, the full composition of the product (with exact quantity per serving, source, and function of each ingredient), finished product specifications and method of analysis, and a declaration regarding the presence of heavy metals and pesticides , View Document
- Health Product application form signed and stamped from company , 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.
- Law No. (12) of 2015 concerning the regulation of the drug registration system.
- Decree-Law No. (18) of 1997 regulating the profession of pharmacy and pharmaceutical centres
- Decree-Law No. (18) of 1997 regulating the pharmacy profession and pharmaceutical centres
Fees
- 50 : Pharmaceutical Product Renewal
Process Time
- 15 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.
