Ghana - Importing Drug Donations

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Procedure

Apply In-Person:

1. To Apply for Importing Drug Donations in person, the applicant has to approach the Food and drugs authority (FDA) regional office or Food and Drugs Authority in Ghana. Contact link or link
2. The Applicants for drug donations are required to inform Food Drug Authority of such need in Writing.
3. The applicant should state clearly to the Authority that the range of drugs and their quantities are clearly stated and related to the population to be served and the type of health facilities to manage the donation.
4. The applicant must visit the Food Drug Authority for the Authority to verify the Drug Import procedure before the importation of the drug donations is done.
5. The applicant has to make sure that he or she has all the required documents that are required for this process to be successful and they can be found under the "Required Documents" section of this page.
6. Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
7. Submit the original preformed invoice for the consignment of drugs to be imported to Food Drug Authority for assessment and payment.
8. The local technical representative of the Food Drug Authority shall endorse on the pro-forma invoice if the drugs are registered with the Authority.
9. The applicant shall bear in mind that Verification of submitted documentation is carried out to ensure compliance with Food Drug Authority requirements.
10. The Authority shall process the details as per the documents provided and if all are successful, then, the verification Import certificate is issued to the applicant.
11. Upon completion of the above steps, the applicant will be issued with an import drug donation permit.
12. On arrival at the ports of entry, the drug consignment is inspected by Food Drug Authority to ensure that it complies with the earlier approved specifications and regulations before release for use by the population.
13. The applicant must ensure that the imported drug donation should be contained in the current edition of the Essential Drugs List of Uganda or the current edition of the Ghana National Formulary or its provisional lists.
14. The Imported Drug Donation should have a remaining shelf life of at least one year after arrival in Ghana, with exception of vaccines or other biological products which should have at least three quarters of their stated shelf life remaining upon arrival.
15. Generally, the processing time for this procedure is 1 month.

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Required Documents

• Application form
• Clearance letter from Ministry of Health.
• Certificate of destruction of expired drugs prior to issuance of another Licence.
• Previous Approval from Food Drug Authority
• Proof of Services/business-registration/registering imported drug donation.
• Original certificate of registration (Business name).
• Import certificate verified by the Food Drug Authority.
• Proof of Imported Drug donation shelf life of at least one year before and after arrival in Ghana.
• Certificate of incorporation (Company)
• Proof Letter from Ghana Registration Services Bureau.
• Previous Certificate of suitability of premises.
• Proof that the imported drug donation is enclosed in the current edition of the Essential Drugs List of Ghana.
• The pro-forma invoice of imported Drug Donation to Ministry of Health (MOH) is also needed.
• Current Certificate of Full Name as Importer of drug Donation.
• List of items (Drug Donation)
• Certificate of donation (Certificate of Donation this is a certificate that depicts that the supplied products is a donation.)
• ISO Certificate (International standards organization (ISO) certificate this is a certificate that meets international standards)
• GMP certificate (Good Manufacturing Practice (GMP) Certificate this is to certify that the company meets the international standards of manufacturing medicines.)
• Certificate of Registration (this is a certificate that the Imported Drug Donation has been registered and it is in use in the country of origin.)
• Certificate of Pharmaceutical Product (this is a license approved by Medicine Regulatory Unit (Ministry of Health) from country of origin.)

Office Locations & Contacts

Cover Letter Addressed To:
Food and Drugs Authority
Health consultant in Accra, Ghana. 17 Nelson Mandela Ave, Accra, Ghana.
JRG9+2Q Accra, Ghana
P.O. Box CT 2783
Cantonments – Accra
GHANA.

Return Completed Form To:
Chief Executive Officer,
Food and Drugs Authority,
17 South Legon Commercial Areas,
SHIASHIE, ACCRA.
Contact link
Location link

Ministry of Health
Address: SekouToure Avenue North Ridge
Adjacent National Health Insurance Head OfficeAccra
HR23+VF2, Accra
P.O. Box M 44 Accra Ghana
Digital Address: GA-029-4296
Fax NO: +233 302 665651
Telephone: +233 302 665651/+233302668782
Email: [email protected]
Contact link
Location link

Ministry of Food and Agriculture
Government office in Accra, Ghana
Address: Kinbu Rd, Accra, Ghana
HR23+M8 Accra, Ghana
P. O. Box M37, Accra Accra
Telephone :(+233)021-662961, 663036, 662810
Fax number: (+233-21) 668245
Location link
Website Link

Eligibility

• Any person of 18 years carrying out drug business in Ghana are eligible to import Drug Donation.

Fees

• Verification fees for commercial consignments and donations to commercial organizations and Government Ministries, departments, projects, programmes and institutions 2.0% of FOB Price.
• Verification fees for donations of up to US $ 1000, to non-profit making charitable NGOs 100,000 GHS.
• Verification fees for donations of US $ 1001-5000, to non-profit making charitable NGOs 200,000 GHS.
• Verification fees for donations of over US $ 5000 to non-profit charitable NGOs 300,000 GHS.

Validity

• The license is valid for one year.

Documents to Use

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Sample Documents

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Processing Time

• The Processing time for this procedure is 1 month.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• The quality of the drugs Donated should always comply with standards in the donor country.
• The donor agency should not ignore local administrative procedures for receiving and distributing medical supplies.
• Donated drugs should not have a high declared value.
• Drugs should not be donated in the wrong quantities.

Required Information

• Name of Applicant
• Telephone number(s)
• Postal Address
• E-mail address
• Customer/Importer name
• Business Name
• Information on the import drug donation.
• Name of Proposed License Holder (if a limited company please state country and year of registration)
• Importer License Number (if known)
• Drug Business Details
• Address of principal importer.

Need for the Document

• Applicant will need to secure an import license/permit, if the applicant will be engage the business for importing drug Donations into Ghana.

Information which might help

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Other uses of the Document/Certificate

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e.g. Birth Certificate can be used as proof of identity.

External Links

Link

Others

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