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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 travelers 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
Provisionally Authorised Medicinal Products Register:
The Medicinal Products Act 2011 requires that every medicinal product for importation, manufacture, export, sale or distribution must be registered.
The process for provisional medicine registration is streamlined through the Fiji MRA Online Services Portal, which allows for the electronic submission and review of product registration applications.
The Online Services Portal also allows for faster registration of products already approved in Australia or New Zealand.
To list a medicine on the Provisionally Authorised Medicinal Products Register:
In order to access the system, you will first need to register a user account within the Online Services Portal. 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.
Before getting started, you will need:
- Company registration certificate, company details, and license documents to register as a sponsor company within the Online Services Portal.
- Information about the medicine(s) you wish to register in the Online Services Portal.
Supplying to government
The Fiji MRA ensures that goods supplied to MHMS meet the requirements for pre-qualification. Accordingly, all manufacturers and products must meet the pre-qualification 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 requested 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.
Follow this link to the Fiji MRA Online Services Portal.
Helpful documents:
Guidelines for the Prequalification of Pharmaceutical Products
Provisional Registration GUIDELINE
Manufacturer Prequalification FAQs
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
- 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). - Provide recommendation(s) and feedback for the identified adverse reactions.
- Sharing the above information (1 and 2) with international regulatory authorities, including the WHO.
- Issuing alerts on substandard, falsified, and contaminated medicines (and also defective medicine equipment), that may be in use in the public and private sectors.
- Issuing alerts for the recall of medicines and medicinal products where the risks outweigh the benefits.
Helpful documents:
Adverse Drug Reaction Reporting Form
Adverse Event Following Immunisation form.
Contact us:
Email: FijiMRA@health.gov.fj
Phone: 8921665