Brunei Drug Product Registration

The documents required for Part I, Part II, Part III and Part IV are as follows:

Part I: Administrative Data and Product Information

Section 1: Application Form – Form No: BDMCA/DPS/01

Section 2: Letter of Authorisation

Section 3: Certifications Section

Section 4: Labelling Section

Section 5: Product Information

Part II: Quality

Section 1: Application Form for Quality Requirements of the Drug Substance (Form No. BCMCA/DPS/02/A)

Section 2: Application Form for Quality Requirements of the Drug Product (Form No. BCMCA/DPS/02/B)

Part III: Non-Clinical

Section 1: Table of Contents

 Section 2: Non-clinical Overview

 Section 3: Non-clinical Summary (Written and Tabulated)

Section 4: Non-clinical Study Reports (As requested)

Section 5: List of Key Literature References

In reference countries where the original goods have already been registered and authorized for marketing authorization, Non-clinical Study Reports (Section D) might not be necessary. Thus, individual Study Reports may be sought for appropriate papers if needed.

Generic products, certain Major variation products, and minor variation products are exempt from the requirement for non-clinical papers (Part III).

Note: Part I and Part II must be presented in hard copy to be considered. Parts III and IV may be submitted on a CD or DVD.

Part IV: Clinical Documents

Section 1: Table of Contents

Section 2: Clinical Overview

Section 3: Clinical Summary

 Section 4: Tabular Listing of All Clinical Studies

Section 5: Clinical Study Reports (If applicable)

Section 6: List of Key Literature References

Certain Major Variation Products, Generic Products, and Products with Minor Variations do not require a Clinical Summary (section C). If the original products have already been registered and given the go-ahead for market authorization in the reference countries, then the Clinical Study Reports for NCEs, Biotechnological Products, and other Major Variation Products may not be necessary for ASEAN member nations. Nonetheless, the Clinical Study Reports may be asked for more papers if necessary.

NCEs, biotechnological products, and other major variation products might not need Clinical Study Reports (Section E) if the original products have previously received market permission and registration in Reference Countries. Thus, if necessary, Requests for Study Reports for required documents may be made.

Application Fees

The Processing Charge

The $200 processing fee must be paid at the time the application for a medical product registration is submitted. Regardless of the BDMCA’s ultimate judgment, the processing fee is non-refundable after the application has been filed.

Product Licensing Charge

The product license certificate has a five-year validity period. The first year is free of charge, and after that, a $50 fee must be paid each year.

Amendment Charge

After the BDMCA approves the modification, the amendment charge is due. The major amendment charge is B$150, while the small amendment price is B$50.

Procedure of Application for Registration of Medicinal Product

Stage 1: Receipt of application by appointment (1 day)

• Obtain application forms from DRU or MOH website
• Fill application forms according to guideline
• Make appointment with DRU for submission of application
• Submit application forms with relevant documents to DRU
• Screening of product application dossier by DRU for completeness according to checklist Payment of processing fee of B$200 per product I
• Issuance of receipt of payment and Acknowledgement slip with Screening Ref. No. by DRU

Stage 2: Acknowledge receipt of application (10 day)

• Validation for completeness of the product application dossier by DRU
• Issuance of Acknowledgement letter of receipt of application with LOA Ref. No. by DRU

Stage 3: Evaluation (NCE: 225 days Generic: 110 days Abridged: 110 days)

• Evaluation by DRU

Stage 4: Reporting (90 days)

• Report of evaluation and recommendations to DRC
• Report of recommendations from DRC to BDMCA for final decision

Stage 5: Certification (10 days)

• Applicant is informed
• Payment of Product License fee of B$200 (valid for 5 years)
• Issuance of receipt of payment by DRU
• Incomplete Issuance of Product License Certificate by DRU