The Fiji Provisional Registration of Medicinal Products is a regulatory process designed to ensure that medicines meet the necessary safety, efficacy, and quality standards before being made available for public use in Fiji. This process is facilitated through the Fiji MRA Online Services Portal, which allows for the electronic submission and review of registration applications. The portal also provides a streamlined registration pathway for products already approved in Australia or New Zealand, ensuring efficient access to approved medicines in Fiji. 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.
Step 1: Register with FCCC
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To sell or supply medicines to anyone other than the patient using the medicine, you must obtain a wholesaler license. |
Step 2: Create an Account with Fiji MRA Online Service Portal
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Applicants are to visit the Fiji MRA Online Services Portal to create a user account using the online registration form and register. |
Step 3: Submit the Application [Online]
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To obtain a provisional registration for medicinal products, To apply, you must complete the application online through the Fiji MRA Online Services Portal, which is accessible via the Fiji MRA website. The process involves registering an account on the Portal, where applicants can submit their application for approval. |
Step 4: Listing Your Medicinal Products on the Provisionally Authorized Medicinal Product Register [Online]
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An application to Provisional Registration of Medicinal Products must be approved by the Board before you may deal with the medicinal product |
| # | Title | Description | Issued By | File |
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| # | Name | Description | Measure Type | Agency | Comments | Legal Document | Validity To | Measure Class |
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| 1 | Provisional Registration of Medicinal Products | 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. | Registration Requirement | Fiji Medicines Regulatory Authority (MRA) | It is important to note that provisional registration is a preliminary step toward the full registration of medicinal products in Fiji. Once full registration is implemented, the provisional registration process will cease. | Medicinal Products Act 2011 | 0002-12-06 | Good |
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