Uganda - Importing Drug Donations

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Procedure

1. The Applicants for drug donations are required to inform National Drug Authority of such need in Writing.
2. The applicant should state clearly to the Authority that the:-
   • 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.
3. The applicant MUST visit the National Drug Authority for the Authority to verify the Drug Import procedure before the importation of the drug donations is done.
4. Submit the original proforma invoice for the consignment of drugs to be imported to National Drug Authority for assessment and payment.
5. The local technical representative of the National Drug Authority shall endorse on the pro-forma invoice if the drugs are registered with the Authority.
6. The applicant shall bear in mind that Verification of submitted documentation is carried out to ensure compliance with National Drug Authority requirements.
7. The Authority shall process the details as per the documents provided and if all are successful the verification Import certificate is issued to the applicant.
8. Upon completion of the above steps, the applicant will be issued with an import drug donation permit.
9. On arrival at the ports of entry, the drug consignment is inspected by National Drug Authority to ensure that it complies with the earlier approved specifications and regulations before release for use by the population.
10. 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 Uganda National Formulary or its provisional lists.
11. The Imported Drug Donation should have a remaining shelf life of at least one year after arrival in Uganda, with exception of vaccines or other biological products which should have at least three quarters of their stated shelf life remaining upon arrival.
    

Note: National Drug Authority is committed to providing the highest possible standard of health care to the entire population of Uganda through access to quality and safe medicines.

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Required Documents

1. Clearance letter from Ministry of Health
2. Certificate of destruction of expired drugs prior to issuance of another Licence.
3. Previous Approval from National Drug Authority
4. Proof of Services/business-registration/registering imported drug donation.
5. Original certificate of registration (Business name)
6. Import certificate verified by the National Drug Authority.
7. Proof of Imported Drug donation shelf life of at least one year before and after arrival in Uganda
8. Certificate of incorporation (Company)
9. Proof Letter from Uganda Registration Services Bureau
10. Previous Certificate of suitability of premises
11. Proof that the imported drug donation is enclosed in the current edition of the Essential Drugs List of Uganda.
12. The pro-forma invoice of imported Drug Donation to Ministry of Health (MRU) is also needed.
13. Current Certificate of Full Name as Importer of drug Donation.
14. List of items(Drug Donation) –
15. Certificate of donation (Certificate of Donation this is a certificate that depicts that the supplied products is a donation.)
16. ISO Certificate (International standards organization (ISO) certificate this is a certificate that meets international standards)
17. GMP certificate (Good Manufacturing Practice (GMP) Certificate this is to certify that the company meets the international standards of manufacturing medicines.)
18. 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.)
19. Certificate of Pharmaceutical Product (this is a license approved by Medicine Regulatory Unit (Ministry of Health) from country of origin.)

Office Locations & Contacts

National Drug Authority
Secretariat office
Plot No. 19, Rumee Towers, Lumumba Avenue,
P.O. Box 23096, Kampala, Uganda.
Tel: +256-414-255665,
Tel: +256-414-347391/2
Fax :(256) 41-255758
Email: [email protected]
Website:National Drug Authority

The Pharmaceutical Society of Uganda,
Pharmacy House
Plot 1847 Kyambogo, Banda.
P.O. Box 377, Kampala, Uganda.
Tel: 256-414-348-796
Email:[email protected]
Website:Pharmaceutical society of Uganda

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Eligibility

• You will need to secure an import license/permit if you will be importing drug Donations into Uganda
• Any person of 18 years carrying out drug business in Uganda 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 100,000Ugshs.
• Verification fees for donations of US $ 1001-5000, to non-profit making charitable NGOs 200,000Ugsh.
• Verification fees for donations of over US $ 5000 to non-profit charitable NGOs 300,000 Ugshs.

Validity

Valid for 1 year.

Documents to Use

Please attach documents that can be used by people. e.g. links

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Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Maximum Processing time 2 Months.

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.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

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Instructions

• The quality of the drugs Donated should always comply with standards in the donor country.
• The donor agency should not ignores 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

• Customer/Importer name
• Business Name
• List of imported drugs
• Commitment letter of the National Drug Authority.
• Commitment letter of the importer of donated drugs.
• National Drag Authority invoice.
• 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.

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Need for the Document

 Please provide the need for the procedure. e.g. Birth Certificate - why do we need to have a birth certificate?

Information which might help

• All applicants should collect application forms from the following locations:
• District Assistant Drug Inspector (DDI) based in the office of the DHO in every district.
  
  

Regional office located at the following locations:

• Central Region-Premier complex Nakawa.
• South Eastern Region-Rippon Gardens, jinja
• Eastern Region-Kwapa Road, Tororo
• Northern Region-Erute Road,Lira
• Western Region- Mugwana Center,Plot30,Old Toro Road, Hoima
• South Western Region-Kamukuzi, Mbarara
• West Nile Region-Plot1 Mt. Wati Road Anafiyo-Arua

• Medicines are an essential element in alleviating suffering, and international humanitarian relief efforts can greatly benefit from donations of appropriate drugs.
• Donated drugs are often not relevant for the emergency situation, for the disease pattern or for the level of care that is available. They are often unknown to local health professionals and patients, and may not comply with locally agreed drug policies and standard treatment guidelines; they may even be dangerous.
• Uganda has very stringent restrictions and procedures for importing donated drugs. This is done to ensure that foreign injurious drugs, poisonous and noxious drugs are not brought into the country. This procedure is for guidelines for person(s)companies and other stakeholders involved in any act of importation of donated drugs into Uganda.

The Uganda Government controls the import of donated drugs into Country. The controls include:

• An absolute prohibition, where you are not allowed to import the donated drugs in any circumstances, or
• A restriction, where you need to have written permission in order to import the donated drugs.
• These donated drugs are strictly controlled by the government.
• Donated drugs can only be supplied by persons or companies that are authorized by special permission under the laws of a state Uganda.
• Donated drugs are exported at least twelve months before their expiry date.
• This procedure is for guidelines for person(s)companies and other stakeholders involved in any act of importation of Donated drugs into Uganda.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• External Link 1
• External Link 2

Others

More information which might help people.

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