Service Directory
Alternative and Complementary Medicine Approval
This service enables registered local agents and distributors of alternative and complementary medicines to submit applications for approval to import, distribute, and sell these products in the Kingdom of Bahrain. It ensures that all alternative and complementary medical products comply with established standards of quality, safety, and efficacy, thereby protecting public health. Upon completion of the regulatory assessment and payment of the prescribed fees, approval for the alternative and complementary medicines with a validity of five years will be issued.
Service Conditions
- Valid pharmacy license with related activity
Required Attachments
- Worldwide registration and marketing status with date of marketing
- Cover letter from the local agent and company. (Hard copy)
- Valid pharmacy license with related activity.
- Application form. (Hard copy)
- Valid Good Manufacturing Practice certificate (GMP) (legalized) (with validity of at least 3 months). (Hard copy)
- Appointment sheet for product composition
- Valid copy of manufacturing license of the manufacturer. (with validity of at least 3 months)
- Valid product registration license/Free sales certificate from country of origin (legalized) (with validity of at least 3 months and must mention the date of marketing). (Hard copy)
- Mock-ups of outer label, inner label and package leaflet
- Product composition certificate (including exact concentration, source & function of both active ingredient and excipient).
- Finished Product Specifications.
- Declaration letter from the company that the product is GMO free.
- Declaration letter for contact details for the company responsible person for communication with NHRA on quality related matters.
- Copy of pharmacopeia reference.
- All documents to be submitted on a CD/DVD including lab file along with hard copy of documents as indicated. Samples for lab analysis with lab file (along with separate CD/DVD).
- Declaration letter from the company declaring the following: This product is free from hormones, heavy metals, antibiotics, steroids, pork and other animal origin derivatives, TSE and any other natural or synthetic material that have harmful effect on biochemical functions or behaviour of human beings.
- Declaration for intended use.
- Declaration for Alcohol content.
- Certificate of analysis for Active ingredient(each) and finished product with inclusive of test for pesticides.
- Description of manufacturing process.
Legal Regulations
- Ministerial Resolution No. (33) of 2016 regulating the practice of alternative and complementary medicine fields
Fees
- 50 : Applications fees
Payment Methods
- Debit Card
- Credit Card
- Benefit
- Through the bank
- Fawateer
Process Time
- 15 Working days : for the online request
Service Provider
National Health Regulatory Authority
