FOOD AND DRUGS AUTHORITY has floated a tender for Regional Joint Medical Products Evaluation for HIV Infections and Related Diseases. The project location is Ghana and the tender is closing on 30 Sep 2019. The tender notice number is MPDER-MRH/EOI/19/007-00, while the TOT Ref Number is 36105795. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.

Expired Tender

Procurement Summary

Country : Ghana

Summary : Regional Joint Medical Products Evaluation for HIV Infections and Related Diseases

Deadline : 30 Sep 2019

Other Information

Notice Type : Tender

TOT Ref.No.: 36105795

Document Ref. No. : MPDER-MRH/EOI/19/007-00

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 Regional Joint Medical Products Evaluation for HIV Infections and Related Diseases

Manufacturers for HIV.

INTRODUCTION
The West Africa Medicines Regulation Harmonization (WA-MRH) Project has agreed a single process for regional medical product evaluation to enable the registration of medicinal products in the 15 ECOWAS Member States.
This call is an invitation to manufacturers of anti-malaria medicines to submit Expressions of Interest (EOI) for the Regional Joint Medical Products evaluation for registration under this project.
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 HIV 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 HIV
Infections and Related Diseases, based on WAHO’s assessment of the priority health
needs in the region, and WHO’s evidenced-based treatment guidelines.

Antiretrovirals as single-ingredient formulations for use in adults and
adolescents:
? Nucleoside/Nucleotide Reverse Transcriptase Inhibitors:
o Lamivudine, tablet, 300mg
? Non-Nucleoside Reverse Transcriptase Inhibitors:
o Efavirenz, tablet 400mg
o Etravirine, tablet, 200mg
? Integrase Inhibitors:
o Dolutegravir, tablet 50mg, preferably scored and dispersible
o Raltegravir, tablet 400mg

? Nucleoside/Nucleotide Reverse Transcriptase Inhibitors plus Nonnucleoside Reverse Transcriptase Inhibitors:
o Emtricitabine/Tenofovir disoproxil fumarate/Efavirenz, tablet
200mg/300mg/400mg
o Lamivudine/Tenofovir disoproxil fumarate/Efavirenz, tablet
300mg/300mg/400mg
o Lamivudine/Tenofovir disoproxil fumarate/Efavirenz, tablet
300mg/300mg/600mg

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.

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