| Name | Provisional Registration of Medicinal Products |
|---|---|
| Description | 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. |
| Comments | 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. |
| Validity From | 01-01-2011 |
| Validity To | 08-12-0002 |
| Reference | The Medicinal Products Act 2011 section 29 and National Medicinal Products Policy 2013 |
| Measure Type | Registration Requirement |
| Agency | Fiji Medicines Regulatory Authority (MRA) |
| Legal Document | - Medicinal Products Act 2011 |
Procedures
| # | Procedure Name | Description | Category | View Detail |
|---|---|---|---|---|
| 1 | Provisional Registration of Medicinal Products | The Medicinal Products Act 2011 mandates that all medicinal products for importation, manufacture, export, sale, or distribution in Fiji must be registered with Medicine Regulatory Authority of Fiji. | Import/Export |
Forms
| # | Title | Description | Issued By | File |
|---|
Commodity/s
| # | HS Code | Description |
|---|---|---|
| 1 | 30032000 | - Other, containing other antibiotics |
| 2 | 30033100 | - - containing insulin |
| 3 | 30033900 | - - other |
| 4 | 30034100 | containing ephedrine or its salt |
| 5 | 30034200 | containing pseudoephedrine (INN) or its salt |
| 6 | 30034300 | containing norephedrine or its salt |
| 7 | 30034900 | Other |
| 8 | 30036000 | Other containing antimalaria principle describe in subheading 2 of this chapter |
| 9 | 30039000 | - Other 30.04 Medicaments (excluding goods of heading No. 30.02, 30.05 or 30.06 consis |
| 10 | 30041000 | - containing penicillins or derivatives thereof, with a penicillanic acid structure, ... |
| 11 | 30042000 | - Other, containing other antibiotics |
| 12 | 30043100 | - - containing insulin |
| 13 | 30043200 | -- Containing corticosteroid hormones, their derivatives and structural analogues |
| 14 | 30043900 | - - other |
| 15 | 30044100 | containing ephedrine or its salt |
| 16 | 30044200 | containing pseudepheodrine(INN) or its salt |
| 17 | 30044300 | containing norepheodrine or its salt |
| 18 | 30044900 | Other |
| 19 | 30045000 | Other containing vitamins or other products of headings 29.36 |
| 20 | 30046000 | Other containing antimalarial active principles describe in subheading note 2 to this chapter |
| 21 | 30049000 | - Other |
Step-by-Step Guide
| # | Process name | Process short name | Activity |
|---|
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