Prequalification of Finished Pharmaceutical Products and their Manufacturers.

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	30012000	- Extracts of glands or other organs or of their sections
2	30019000	- other
3	30022000	- Vaccines for human medicine
4	30024100	Vaccines for human medicine
5	30024200	Vaccines for human medicine
6	30032000	- Other, containing other antibiotics
7	30033100	- - containing insulin
8	30033900	- - other
9	30034100	containing ephedrine or its salt
10	30034200	containing pseudoephedrine (INN) or its salt
11	30034300	containing norephedrine or its salt
12	30034900	Other
13	30036000	Other containing antimalaria principle describe in subheading 2 of this chapter
14	30039000	- Other 30.04 Medicaments (excluding goods of heading No. 30.02, 30.05 or 30.06 consis
15	30041000	- containing penicillins or derivatives thereof, with a penicillanic acid structure, ...
16	30042000	- Other, containing other antibiotics
17	30043100	- - containing insulin
18	30043200	-- Containing corticosteroid hormones, their derivatives and structural analogues
19	30043900	- - other
20	30044100	containing ephedrine or its salt
21	30044200	containing pseudepheodrine(INN) or its salt
22	30044300	containing norepheodrine or its salt
23	30044900	Other
24	30045000	Other containing vitamins or other products of headings 29.36
25	30046000	Other containing antimalarial active principles describe in subheading note 2 to this chapter
26	30049000	- Other
27	30051000	- Adhesive dressing and other articles having an adhesive layer
28	30059090	- - - Other
29	30059010	- - - Wadding, including cotton wool and absorbent cotton
30	30061000	- sterile surgical catgut, similar sterile suture materials and sterile tissue adhesiv..
31	30062000	- Blood-grouping reagents
32	30063000	- Opacifying preparations for x-ray examinations; diagnostic reagents designed to be ...
33	30064000	- Dental cements and other dental fillings; bone reconstruction cements
34	30065000	- First-aid boxes and kits
35	30066000	- Chemical contraceptive preparations based on other products of heading 29.37 or on spe
36	30067000	- Gel preparations designed to be used in human or veterinary medicine as a lubricant fo
37	30069100	--Appliance identifiable for ostomy use
38	30069200	--waste pharmaceuticals
39	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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