Required Documents

Requirements for Prequalification of Manufacturers

1. Prequalification Requirement:

   • Manufacturers of FPPs must be prequalified by the Fiji MRA.

2. Separate Applications:

   • Separate applications are needed for each manufacturing site.

3. Eligibility Criteria:

   • Manufacturing site licensed by the NRA of its country.
   • Valid GMP certificate from an NRA recognized by the Fiji MRA.
   • Legal agreement to supply FPPs to the Fiji MHMS.

4. Documentation:

   • GMP Compliance: Evidence of GMP certification (issued by a recognized NRA).
   • Letter of Authorisation:
     • Written in plain English.
     • Confirm supplier authorization to supply products to Fiji MHMS.
     • Signed by the authorized representative.
     • Confirm the identities of the supplier and manufacturer.

Requirements for Prequalification of Finished Pharmaceutical Products (FPPs)

1. Prequalification Requirement:

   • FPPs must be prequalified before supplying to Fiji MHMS.

2. Eligibility Criteria:

   • Manufactured by a prequalified manufacturer.
   • Registered or authorized in a country with a recognized NRA.
   • Meets pharmacopeial standards (BP, Ph. Eur.., USP).
   • Meets Fiji MRA standards for labelling and packaging.
   • Included in the WHO List of Prequalified Medicines (if applicable).

3. Documentation:

   • Market Authorization:
     • CoPP or Registration Certificate from the NRA.
     • Evidence of WHO prequalification.
   • Quality Compliance:
     • Finished Product Specifications or Certificate of Analysis.
   • Labelling and Packaging:
     • Must meet Fiji MRA standards (in English, with required information).
     • Packaging must protect FPPs from adverse conditions.

4. Declaration:

   • FPP supplied will be identical to the registered product.
   • All information is accurate and complete.

Fees or Charges

Free

Estimated Total Time

N/A

Contact Address

Ministry of Health and Medical Services, Dinem House, 88 Amy St, Suva, Fiji

Phone: +679 892 665

e-mail: FIJIMRA@health.gov.fj

Website: www.health.gov.fj