| 1 |
Import Permit Medicinal Products |
Permit Requirement |
Fiji Medicines Regulatory Authority (MRA) |
An application to import a medicinal product must be approved by the Medicinal Products Board before the applicant may import that medicinal product. The Board require that the medicinal products imported into Fiji meet prescribed standards of quality, safety, and efficacy, and that they are imported only by authorized and licensed persons. |
Medicinal Products Act 2011 |
Import permit for Medicinal Products [Online]
|
06-12-0002 |
ALL |
| 2 |
Provisional Registration of Medicinal Products |
Registration Requirement |
Fiji Medicines Regulatory Authority (MRA) |
The Medicinal Products Act 2011 section 29 requires that no person shall import, manufacture, export, store, sell, distribute, transport, offer for
sale, expose to sale or advertise any medicinal product which is not registered with the Fiji Medicine Regulatory Authority. The process is a requirement for all licensed importers of medicines in Fiji, including wholesalers and pharmacies, regardless of whether they supply the government or the private sector. Overseas-based suppliers to the Ministry of Health and Medical Services (MOHMS) are not required to undergo provisional registration but must apply for Finished Pharmaceutical Product Prequalification for each product they intend to supply. |
Medicinal Products Act 2011 |
Provisional Registration of Medicinal Products
|
08-12-0002 |
ALL |
| 3 |
Export Permit for Medicinal Products for Commercial Purposes |
Permit Requirement |
Fiji Medicines Regulatory Authority (MRA) |
Export permits are currently only issued for controlled medicines, and the process is handled manually. Only licensed wholesalers and pharmacies are eligible to apply for an export permit. This process ensures that the products meet the necessary safety, efficacy, and quality standards and are in compliance with both Fiji’s domestic regulations and international requirements. |
Illicit Drugs Control Act No. 9 of 2004 |
|
06-12-0002 |
ALL |
| 4 |
Prequalification of Finished Pharmaceutical Products and their Manufacturers. |
Registration Requirement |
Fiji Medicines Regulatory Authority (MRA) |
Prequalification of Finished Pharmaceutical Products (FPPs) and Their Manufacturers are based on the National Medicinal Products Policy 2013 and the Medicinal Products Act 2011. The prequalification process is mandatory for all medicines intended for procurement or use by the Ministry of Health and Medical Services through the Fiji Pharmaceutical and Biomedical Services (FPBS). Both local and overseas-based suppliers must have their products prequalified before they can be purchased for use in Fiji,
|
Medicinal Products Act 2011 |
Pre-qualification of Finished Pharmaceutical Products [Online]
|
10-12-0002 |
ALL |