Manufacturers of Medicinal Products for Malaria Tender, Ghana - 36105816

Procurement Summary

Country : Ghana

Summary : Manufacturers of Medicinal Products for Malaria

Deadline : 30 Sep 2019

Other Information

Notice Type : Tender

TOT Ref.No.: 36105816

Document Ref. No. : MPDER-MRH/EOI/19/001-00

Competition : ICB

Financier : Other Funding Agencies

Purchaser Ownership : -

Tender Value : Refer Document

Purchaser's Detail

Purchaser : FOOD AND DRUGS AUTHORITY
Room 316, FDA Head Office, 17 Indian Ocean Street, off Nelson Mandela Avenue, South Legon Commercial Area, Shiashie, Accra, Telephone: +233554456478
Ghana
Email :fda@fdaghana.gov.gh

Tender Details

Expression of Interest are invited for Manufacturers of Medicinal Products for Malaria.

CALL FOR EXPRESSION OF INTEREST (EOI) FOR REGIONAL JOINT MEDICAL PRODUCTS EVALUATION FOR ANTIMALARIA MEDICINES

The invitation is published in accordance with the document titled “WA-MRH Regional
Joint Medical Product Evaluation Procedure for pharmaceutical product dossier”, which is
dated July 2019 and is available on WAHO Website (www.wahooas.org) under the section
Resources, sub-section Publications and Research, sub sub-section Essential
Medicines and Vaccines”.
Assessment of product(s) submitted under this invitation will include evaluation of:
? Product dossiers, which must include product data and information as specified in
the guidelines for submission.
? manufacturing sites, which must adhere to good manufacturing practices (GMP)
? Product samples, which must adhere to the requisite specifications

MEDICINAL PRODUCTS FOR THIS EOI
The aim of this EOI is to evaluate a specific range of medical products available in relation
to the management of Malaria. The medicines listed in this invitation have been identified
by the Expert Working Group for Medical Product Dossier Evaluation and Registration of
the WA-MRH Project as vital to effective treatment of malaria, based on WAHO’s
assessment of the priority health needs in the region, and WHO’s evidenced-based
treatment guidelines.
Artemisinin-based fixed dose oral combination formulations
? Artemether/Lumefantrine
o tablet 20 mg/120 mg
o tablet 40 mg/240 mg
o tablet 60 mg/360 mg
o tablet 80 mg/480 mg
? Artesunate/Amodiaquine
o tablet 50 mg/135 mg
o tablet 100 mg/270 mg
? Artesunate/Mefloquine
o tablet 100 mg/200 mg
? Artesunate/Pyronaridine
o tablet 60 mg/180 mg
? Dihydroartemisinin/Piperaquine Phosphate
o tablet 40 mg/320 mg
o tablet 60 mg/480 mg
o tablet (scored) 80 mg/640 mg
Artemisinin-based fixed dose combination, oral paediatric formulations,
preferably dispersible
? Artemether/Lumefantrine, tablet 20 mg/120 mg
? Artesunate/Amodiaquine, tablet 25 mg/67.5 mg
? Artesunate/Mefloquine, tablet 25 mg/50 mg
? Artesunate/Pyronaridine tablet 20 mg/60 mg
? Dihydroartemisinin/Piperaquine, phosphate, tablet 20 mg/160 mg (scored) tablet
30 mg/240 mg tablet 40 mg/320 mg
Artemisinin-based single-ingredient formulations
? Artemether, oily injection 20 mg/ml; 40 mg/ml; 80 mg/ml; 100 mg/ml
? Artesunate, powder for injection 30 mg; 60 mg; 120 mg (vial)
? Artesunate, suppositories 50 mg; 100 mg; 200mg

The Lead Coordinating NMRA for this invitation for EOI is the NMRA of Ghana, the Food
and Drug Authority (http://www.fdaghana.gov.gh).
In order to submit an expression of interest for product evaluation, the applicant must do
the following:
1. The applicant will pay the management fees of US$ 500 for the lead coordinating
NMRA (FDA-Ghana) for reception, screening, file management and communication
when submitting the file. The Bank account details are as follows:
Food and Drugs Authority
Bank of Ghana
Account No: 1018631529507
Swift Code: BAGHGHAC.
2. The applicant should download and complete the Market Authorization application
(MA) file in accordance with the harmonized Common Technical Document (CTD)
format on WAHO Website (www.wahooas.org) under the section Resources, subsection Publications and Research, sub sub-section Essential Medicines and
Vaccines”. The completed application MA file should be submitted electronically to
the lead coordinating NMRA (fda@fdaghana.gov.gh) with a hard copy sent to Room
316, FDA Head Office, 17 Indian Ocean Street, off Nelson Mandela Avenue, South
Legon Commercial Area, Shiashie, Accra, GHANA (telephone: +233554456478).

Documents

 Tender Notice