NameProvisional Registration of Medicinal Products
DescriptionThe 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.
CommentsIt 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 From01-01-2011
Validity To08-12-0002
ReferenceThe Medicinal Products Act 2011 section 29 and National Medicinal Products Policy 2013
Measure TypeRegistration Requirement
AgencyFiji 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 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.
2 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
3 300310 - Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives:
4 300340 - Containing alkaloids or derivatives thereof but not containing hormones or other products of heading 2937 or antibiotics
5 300440 - Containing alkaloids or derivatives thereof, but not containing hormones, other products of heading 29.37 or antibiotics:
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
Step-by-Step Guide
# Process name Process short name Activity
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