| Name | Prequalification of Finished Pharmaceutical Products and their Manufacturers. |
|---|---|
| Description | 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, |
| Comments | Prequalification does not guarantee solicitation for supply, and the Fiji MRA reserves the right to modify application requirements at any stage. |
| Validity From | 01-01-2011 |
| Validity To | 10-12-0002 |
| Measure Type | Registration Requirement |
| Agency | Fiji Medicines Regulatory Authority (MRA) |
| Legal Document | - Medicinal Products Act 2011 |
Procedures
| # | Procedure Name | Description | Category | View Detail |
|---|---|---|---|---|
| 1 | Pre-qualification of Finished Pharmaceutical Products [Online] | The Fiji Medicines Regulatory Authority (Fiji MRA) is responsible for assessing applications to ensure that FPPs meet standards for quality, safety, and efficacy. Prequalification is required for all FPPs before they can be supplied to the Fiji MHMS, and suppliers must apply for both product and manufacturer prequalification. | Import |
Forms
| # | Title | Description | Issued By | File |
|---|
Commodity/s
| # | HS Code | Description |
|---|---|---|
| 1 | 3001 | Glands and other organs for organo-therapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or |
| 2 | 3003 | Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. |
| 3 | 3004 | Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packin |
| 4 | 3005 | Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. |
| 5 | 3006 | Pharmaceutical goods specified in Note 4 to this Chapter. |
| 6 | 300220 | - Vaccines for human medicine: |
| 7 | 300310 | - Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives: |
| 8 | 300320 | - Containing other antibiotics |
| 9 | 300331 | - Containing hormones or other products of heading 2937 but not containing antibiotics: |
| 10 | 300339 | - - Other |
| 11 | 300340 | - Containing alkaloids or derivatives thereof but not containing hormones or other products of heading 2937 or antibiotics |
| 12 | 300440 | - Containing alkaloids or derivatives thereof, but not containing hormones, other products of heading 29.37 or antibiotics: |
| 13 | 30012000 | - Extracts of glands or other organs or of their sections |
| 14 | 30019000 | - other |
| 15 | 30022000 | - Vaccines for human medicine |
| 16 | 30024100 | Vaccines for human medicine |
| 17 | 30024200 | Vaccines for human medicine |
| 18 | 30032000 | - Other, containing other antibiotics |
| 19 | 30033100 | - - containing insulin |
| 20 | 30033900 | - - other |
| 21 | 30034100 | containing ephedrine or its salt |
| 22 | 30034200 | containing pseudoephedrine (INN) or its salt |
| 23 | 30034300 | containing norephedrine or its salt |
| 24 | 30034900 | Other |
| 25 | 30036000 | Other containing antimalaria principle describe in subheading 2 of this chapter |
| 26 | 30039000 | - Other 30.04 Medicaments (excluding goods of heading No. 30.02, 30.05 or 30.06 consis |
| 27 | 30041000 | - containing penicillins or derivatives thereof, with a penicillanic acid structure, ... |
| 28 | 30042000 | - Other, containing other antibiotics |
| 29 | 30043100 | - - containing insulin |
| 30 | 30043200 | -- Containing corticosteroid hormones, their derivatives and structural analogues |
| 31 | 30043900 | - - other |
| 32 | 30044100 | containing ephedrine or its salt |
| 33 | 30044200 | containing pseudepheodrine(INN) or its salt |
| 34 | 30044300 | containing norepheodrine or its salt |
| 35 | 30044900 | Other |
| 36 | 30045000 | Other containing vitamins or other products of headings 29.36 |
| 37 | 30046000 | Other containing antimalarial active principles describe in subheading note 2 to this chapter |
| 38 | 30049000 | - Other |
| 39 | 30051000 | - Adhesive dressing and other articles having an adhesive layer |
| 40 | 30059090 | - - - Other |
| 41 | 30059010 | - - - Wadding, including cotton wool and absorbent cotton |
| 42 | 30061000 | - sterile surgical catgut, similar sterile suture materials and sterile tissue adhesiv.. |
| 43 | 30062000 | - Blood-grouping reagents |
| 44 | 30063000 | - Opacifying preparations for x-ray examinations; diagnostic reagents designed to be ... |
| 45 | 30064000 | - Dental cements and other dental fillings; bone reconstruction cements |
| 46 | 30065000 | - First-aid boxes and kits |
| 47 | 30066000 | - Chemical contraceptive preparations based on other products of heading 29.37 or on spe |
| 48 | 30067000 | - Gel preparations designed to be used in human or veterinary medicine as a lubricant fo |
| 49 | 30069100 | --Appliance identifiable for ostomy use |
| 50 | 30069200 | --waste pharmaceuticals |
| 51 | 30069300 | Placebos and blinded (or double-blinded ( or double- blinded ) clinical trial kits |
Step-by-Step Guide
| # | Process name | Process short name | Activity |
|---|
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