Food Supplement/ Health Product Registration in Bahrain

Regulatory Affairs

The National Health Regulatory Authority (NHRA)

5 years

The procedures for new health product are as follows:

• Applicants should prepare a new health product application including the following documents:

1. Cover letter from the local agent signed and stamped.
2. Cover letter from the applicant signed and stamped.
3. Health Product application form signed and stamped from company.
4. Valid Good Manufacturing Practice certificate/ Manufacturing License of the manufacturer (Legalized).
5. Free sale certificate/ Product license from the country of origin (Legalized)
6. Composition of the product (with exact composition per serving, source and function of each ingredient)
7. Finished product specification.
8. Declaration of alcohol content.
9. Declaration of pork free content.
10. Declaration of presence of heavy metals and pesticides (herbal).
11.  List of manufacturers involved in manufacturing process along with their respective role.
12. Mock-ups of outer label, inner label and package leaflet (with company signed & stamped)
13. Registration sample
14. Copy of valid health product shop license with CR
15. Proof of payment
16. All documents in (CD) along with lab documents
17. Lab file in CD with samples for analysis (Lab file in CD with samples for analysis)

• • All documents must be submitted as soft copies, except legalized documents and application forms.

• To submit a health product application, the applicant must request an appointment with the PPR Department on a certain day and time.
• Requests for appointments should be sent to the PPR department, and the applicant will get an email confirming the appointment’s date and time.
• Appointments are assigned first-come first-served, and each applicant will receive the next available appointment, which will depend on demand.
• Valid applications that meet the NHRA’s requirements are accepted.
• The applicant is required to pay the fee as per resolution 12.
• All documents should be submitted as soft copies and should have a validity of at least 3 months.

• Each application is evaluated according to the NHRA standard operating procedures.
• If queries arise, a request for further information will be emailed to the applicant, who will have 30 days to respond to the queries.
• The resolution of queries will oversee the NHRA and does not, in
• Principle, have a time limit, although the absence of any response will result in rejection of the application and will require resubmission.

• It is mandatory to evaluate the product samples for new registration applications before issuance of license.
• Laboratory analysis dossier (lab documents on CD) with sample should be submitted at the time of new registration application submission.

Documents to be Submitted

1.  Samples of the product.
2. Certificate of analysis for the sample submitted.
3. Reference standard for the active ingredients and related substances along with their certificate of analysis.
4. Product composition certificate. v. Complete method of analysis.
5. Product Specification.
6. Material safety data.
7. Documents in CD, DVD or USB.

Minimum quantity of sample required for analysis

• Capsules & Tablets -100 nos
• Oral liquids -10 bottles
• Suppositories- 50 nos
• Creams and ointments- 10 nos
• Powders– 20 nos
• Nasal drops-10 nos
• Ear drops 10 nos

Licensing

A health product license will be issued after approval from licensing committee and payment.

Labelling Requirement for Food Supplement in Bahrain

1. Trade name.
2. Active ingredient.
3. Name of the manufacturer/MAH.
4. Pack size.
5. Dosage form.
6. Storage condition.
7. Batch details: Batch number, manufacturing date (if applicable), expiry date is mandatory.
8. Country of origin
9. Statement consults your health care provider if you have any medical condition or are under any medication.
10. Warning about pregnancy and lactation (if applicable).
11. Warning for alcohol content. (If applicable).

Importation and Clearance Procedure

• Import of pharmaceutical product is governed by Bahrain Pharmacy law which states that “the importation of pharmaceutical product must be through authorized legal entity”.
• Following details should be included in the invoice (in addition to particular like quantity) and will be checked against the approved information:

1. Product name – strength.
2. Pack size – dosage form.
3. Importer name and address (local agent) Batch number.
4. Manufacturing date- expiry date.
5. Manufacture name & address Invoicing date Quantity per batch Storage condition (if cold chain) Shelf life