Regional Joint Medical Products Evaluation for Antimalaria Medicines Tender, Ghana - 36105798

Procurement Summary

Country : Ghana

Summary : Regional Joint Medical Products Evaluation for Antimalaria Medicines

Deadline : 30 Sep 2019

Other Information

Notice Type : Tender

TOT Ref.No.: 36105798

Document Ref. No. : MPDER-MRH/EOI/19/002-00

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

Tender Details

Expression of Interest are invited for Regional Joint Medical Products Evaluation for Antimalaria Medicines.

Manufacturers of Antibacterial Medicine

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 antibacterial infections and related diseases. 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 antibacterial infections and related diseases, based on WAHO’s assessment of the
priority health needs in the region, and WHO’s evidenced-based treatment guidelines.
Cephalosporins
o Cefepime Infusion 1g/50ml
o Cefepime Infusion 2g/100ml
o Cefepime Powder for Injection 500mg
o Cefepime Powder for Injection 1g
o Cefepime Powder for Injection 2g
o Cefpirome Powder for Injection 1g
o Cefpirome Powder for Injection 2g
Carbapenems
o Imipenem/Cilastatin Powder for Injection 250mg/250mg
o Imipenem/Cilastin Powder for Injection 500mg/500mg
o Meropenem Powder for Injection 500mg
o Meropenem Powder for Injection 1000mg
HOW TO SUBMIT AN EOI
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).
3. The applicant should provide samples of the medical product and reference
substances. The sample size shall be in line with the quantity defined by the EWG for
Quality Control and published under the Essential Medicines and Vaccines section
on the WAHO website. The samples should be submitted together with the Dossiers
to the lead coordinating NMRA (FDA-Ghana).
4. After screening, a certificate of eligibility or non-eligibility for full evaluation will be sent
to the applicant by the lead coordinating NMRA. On receipt of a certificate of eligibility
the applicant should pay the full evaluation fee within 30 calendar days to the WAMRH secretariat bank account specified in the certificate:-the applicable fee for the
processing of the application.
a) Certificate of Eligibility
- Applicants in the West Africa Region will pay US$ 8, 000
- Applicants in other regions of Africa will pay US$ 10, 000
- Applicants outside Africa will pay US$ 12, 000

Documents

 Tender Notice