Service Directory
New Medicine Registration Service
This service allows beneficiaries to submit applications for the registration of medicines for the purpose of importation and supply in the Kingdom of Bahrain. It aims to ensure the safety and quality of medicines by meeting stringent standards prior to their entry into the market and use by patients.
Required Attachments
- Agent cover letter
- Cover letter(original company paper, signed and dated)
- Medicine Dossier CD, DVD or USB
Legal Regulations
- Ministerial Resolution No. (32) of 2020 issuing a regulation for the registration system of medicines and pharmaceutical products and specifying pricing and advertising
Fees
- 300 BD : license fees
- 50BD : Submission
Payment Methods
- Debit Card
- Credit Card
- Benefit
- Through the bank
- Fawateer
Process Time
- 35 Working days : for the online request for Medicine New Registration
- 3 Working days : for the online request for Medicine New Registration fast track
Service Provider
National Health Regulatory Authority
Service Processes
- the applicant submits the application through Adweya portal
- the pharmacist reviews the submitted documents and accept the application if all documents are complying.
- The applications are assessed by the pharmacist and proceeds for pricing for complete applications.
- The product is reviewed by the licensing committee prior to approval.
