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Fiji Medicines Regulatory Authority

 

The Fiji Medicines Regulatory Authority (Fiji MRA) is part of the Fiji Pharmaceutical & Biomedical Services Centre (FPBS) in the Ministry of Health and is responsible for the regulation of medicinal products in Fiji.


What we do

The goal of the Fiji MRA is to ensure the health and safety of Fijians by ensuring medicinal products such as medicines and medical devices are acceptably safe, effective, and of high quality.


Our activities include:

    • Drug registration
    • Prequalification
    • Issuance of Import Permits (for controlled substances/ scheduled poisons or chemicals)
    • Issuance of import/export clearances for travellers entering or leaving the country
    • Inspections of premises where medicines are manufactured, stored, distributed, and sold
    • Processing of applications for Licensing of importers/wholesalers/medicine license holders
    • Pharmacovigilance
    • Drug Testing
    • Registration & Licensing of pharmacists
    • Secretariat services for the Fiji Medicinal Products Board and Fiji Pharmacy Profession Board

Fiji MRA Online Services Portal

The Fiji MRA Online Services Portal allows for the electronic management of services delivered by the Fiji MRA.

This includes:

  • Provisional Medicinal Product Registration.
  • Company Registration.
  • Import permits for controlled chemicals / poisons.
  • Prequalification of manufacturers and products for supply to Government.

To access the Online Services Portal, you will first need to register a user account.

Instructions are available here: Registering a user account.


Provisionally Authorised Medicinal Products Register

The Medicinal Products Act 2011 requires that every medicinal product for importation, manufacture, export, sale or distribution in Fiji must be registered. The Fiji Medicinal Products Board has assigned the Fiji MRA the role of managing provisional registration.

Provisional medicinal product registration is managed through the Fiji MRA Online Services Portal, which allows for the electronic submission and review of product registration applications. It also allows for streamlined registration of products already approved in Australia or New Zealand.

Once logged in, you must then provide details of your company in the sponsor registration form to allow for access to the provisional listing application.

To list a medicine on the Provisionally Authorised Medicinal Products Register, you will need:

  • Company registration certificate, company details, and license documents.
  • Information about the medicinal product(s) you wish to list on the Provisionally Authorised Medicinal Products Register.

Useful documents:


Supplying medicinal products to the Fiji Government

The Fiji MRA ensures that goods supplied to MHMS meet the requirements for prequalification. Accordingly, all manufacturers and products must meet the prequalification requirements before a medicinal product can be supplied to MHMS.

The Online Services Portal includes an application process for the prequalification of manufacturers and finished pharmaceutical products to facilitate supply to the government. All suppliers are required to register with the Online Services Portal and complete the application process for pre-qualification.

  • If your product is already on the Provisionally Authorised Medicinal Products Register all relevant information can be automatically transferred to the prequalification application.
  • Any product submitted via the prequalification process will be automatically added to the Provisionally Authorised Medicinal Products Register if approved.
  • All suppliers must be aware of the requirements as outlined by the Guidelines for the Prequalification of Pharmaceutical Products
  • Further guidance material is accessible from the Help menu within the Online Services Portal.

Useful documents:


Import Permits

The Medicinal Products Act 2011 requires that medicinal products imported into Fiji meet prescribed standards of quality, safety, and efficacy, and that they are imported only by authorised and licensed persons.

The Fiji MRA assesses applications for import permits against criteria to ensure that medicinal products supplied in Fiji meet acceptable standards of quality, safety, and efficacy, and that they are sourced from reputable manufacturers through legitimate supply chains.

The Import Permit Guidelines apply to medicinal products imported into Fiji for commerce, donation, personal use or by travellers.

Useful documents:


Donations

Thank you for your interest in donating medicinal products to the Fiji Ministry of Health and Medical Services. Your generosity is appreciated.

The Fiji MHMS has policies to ensure that donations support Fiji’s essential medicines policy, treatment guidelines, training programs and medical system.

The National Medicinal Products Policy describes the requirements for donations. These are underpinned by the Medicinal Products Act 2011.

Donations that meet these requirements are welcomed. However, donations that do not meet these requirements cannot be accepted. In most cases a financial contribution is more helpful than donations of products.

Potential donors must receive an import permit from the Fiji Medicines Regulatory Authority for donations to be granted entry into Fiji. Donations without an import permit will not be granted entry into Fiji.

The Guidelines for Import Permits for Medicinal Products describe the process to apply for an import permit. This checklist is part of the requirements to apply for an import permit.

Useful documents:


Pharmacovigilance

WHO defines this as the “science and activities relating to the detection, assessment, understanding, and prevention of adverse drug effects or any other possible drug-related problem” (2002).

Therefore, the functions of this branch of the Fiji MRA include:

  1. Collecting, assessing, investigating, and monitoring ADR and AEFI reports of adverse reactions.
    (ADR- Adverse Drug Reaction, for all adverse reactions caused by medicines.
    AEFI- Adverse Events Following Immunization, for all reactions caused by vaccines).
  2. Provide recommendation(s) and feedback for the identified adverse reactions.
  3. Sharing the above information (1 and 2) with international regulatory authorities, including the WHO.
  4. Issuing alerts on substandard, falsified, and contaminated medicines (and defective medicine equipment), that may be in use in the public and private sectors.
  5. Issuing alerts for the recall of medicines and medicinal products where the risks outweigh the benefits.

Useful documents:


Contact us:

Email: FijiMRA@health.gov.fj
Phone: 8921665

Last Updated on 1 month by Publishing Team