Tanzania, United Republic of
1.3.1 Tanzania Medical Customs Information
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Assessment Details

From

August 2020

To

August 2020

Name of Assessor

Alexandra Parisien

Title and Position

Emergency Preparedness & Response Officer – Supply Chain, WFP

Contact

alexandra.parisien@wfp.org

Regulations

The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal products) Regulations – 2015:  https://trade.business.go.tz/media/GN%20314%20-%20Registration%20medicines.pdf

The Tanzania Food, Drugs and Cosmetics Act – 2003: https://trade.business.go.tz/media/TFDA%20ACT.pdf

Mainland Tanzania - Regular Regime for Import of Medical Devices and In Vitro Diagnostics: https://trade.business.go.tz/procedure/539/step/350?l=en

Mainland Tanzania - Regular Regime for Import of Medicine: https://trade.business.go.tz/procedure/545?l=en

Duties and Tax Exemption

General infomation on duties and tax exemption in Tanzania can be found on the following page: 1.3 Tanzania Customs Information.

For contact information regarding government custom authorities, please follow the link: 4.1 Tanzania Government Contact List

Emergency Response

There is currently no Emergency Importation/Customs Clearance process applicable only to ‘crisis’ times.  However, for importation of medical supplies and medicines to support the Tanzanian Ministry of Health, Community Development, Gender, Elderly and Children or the Zanzibar Ministry of Health, there are guidelines for donations and independent procedures to follow for both Mainland Tanzania and Zanzibar.

Agreements / Conventions Description

Ratified by Country?

(Yes / No)

WCO (World Customs Organization) member

No

Annex J-5 Revised Kyoto Convention

No 

OCHA Model Agreement

Yes, 01/01/1995

Tampere Convention (on the Provision of Telecommunication Resources for Disaster Mitigation and Relief Operations)

No

Regional Agreements (on emergency/disaster response, but also customs unions, regional integration)

Yes, 07/06/1971

Exemption Regular Regime

Generalities

 All imports should be cleared from customs on presentation of the following documents (please note that not all the documents may be required):

  • Bill of Lading/Airway bill, supplier invoice and packing list
  • Certificate of analysis for each batch
  • Ministry of Finance Duty/Tax Exemption Letter (food and health commodities imports)
  • TMDA import permit (health commodities)
  • Certificate/letter of donation (health commodities) from donor
  • Customs Import Entry Form C63

Exemption Certificate Application Procedure

  1. Vessel’s agents submit manifest to Customs.
  2. Shipping documents submitted to clearing agent at least 7 working days prior to the arrival of the vessel.
  3. Single hard copies of shipment documents are sent to Ministry of Health (MOHCDGEC) together with donation letter and TRA exemption application form 265, MOHCDGEC validate the documents and sign the first part of the exemption application form.
  4. MOHCDGEC notifies TRA through a letter acknowledging they are the consignee and introduces the agent responsible for clearing the shipment.
  5. TRA assess the documents and endorse the exemption by signing form 265.
  6. TRA release 2 copies of the endorsed exemption form that are submitted to customs.

 Import Permit Application Procedure

Requirements for Donated Medicines and Medical Supplies for Tanzania (29 April 2020)

  1. Both health commodities and supplier should be registered by TMDA in order to process importation. The registration process takes about six months. The list of both registered products and suppliers can be found on the following TMDA portal; (https://imis.tmda.go.tz/portal/en/registered-products)
  2. Government donations are usually consigned to the MOHCDGEC which is under special registration with TMDA.
  3. In case of emergency importation of unregistered commodities, registration waiver has to be sought after submission of products’ information and suppliers’ certificates from the country of origin (certificate of analysis, product registration certificate, supplier’s registration certificate).
  4. Certificate of donation is drafted by donor and stamped by MOHCDGEC.
  5. TMDA import permit is obtained by lodging the soft copies of the shipping documents to the online portal. Access to the online portal is obtained by special request through MOHCDGEC.
  6. TMDA approves the documents within 24 hours and issues an invoice for import permit. The cost of invoice permit for health commodities is 0.25% of FOB.
  7. Upon payment, donation letter and MOHCDGEC acknowledgement letter have to be submitted for verification.
  8. Once payment is done, the system issues a permit which is then printed and taken to customs for cargo inspection and clearance upon arrival.
Clearance Procedure
  • Both TRA exemptions and TMDA import permit are submitted to customs together with original copies of shipping documents through the use of registered clearing agents.
  • TMDA office at the port inspect the cargo upon arrival to ensure that they comply with the approved specifications and regulations before they are released, validate the import permit and take samples for laboratory quality testing.
  • Once TMDA release is obtained, TRA exemption is also validated upon inspection of documents.
  • Clearing agent then uploads the all the documents to TRA online system for clearing, wharfage and handling charges. 

Exemption Certificate Document Requirements (for both UN and NGOs)

Duties and Taxes Exemption Certificate Document Requirements (by commodity)

 

Medicines

Medical Devices

Invoice

Yes

(1 soft copy, applies to both UN and NGOs)

Yes

(1 soft copy, applies to both UN and NGOs)

AWB/BL/Other Transport Documents

Yes

(1 copy of the original, applies to both UN and NGOs)

Yes

(1 copy of the original, applies to both UN and NGOs)

Donation/Non-Commercial Certificates

Yes

(1 soft copy, applies to both UN and NGOs)

Yes

(1 soft copy, applies to both UN and NGOs)

Packing Lists

Yes

(1 soft copy, applies to both UN and NGOs)

Yes

(1 soft copy, applies to both UN and NGOs)

Other Documents

Government registration certificate is required for an organisation to get duties and tax exemption.

Additional Notes

Certificate of Donation is required only if you have to claim the exemption of duties. 

Import Permit Document Requirements

Import Permit Document Requirements (by commodity)

 

Medicines

Medical Devices

Invoice

Yes

(One original and two copies of the original, applies to both UN and NGOs)

Yes

(One original and two copies of the original, applies to both UN and NGOs)

AWB/BL/Other Transport Documents

Yes

(1 copy of the original, applies to both UN and NGOs)

Yes

(1 copy of the original, applies to both UN and NGOs)

Donation/Non-Commercial Certificates

Yes

(1 soft copy, applies to both UN and NGOs)

Yes

(1 soft copy, applies to both UN and NGOs)

Packing Lists

Yes

(1 soft copy, applies to both UN and NGOs)

Yes

(1 soft copy, applies to both UN and NGOs)

Other Documents

MOHCDGEC cover letter

TMDA application form

MOHCDGEC cover letter

TMDA application form

Additional Notes

  1. Import permits are required for both cargo in transit that is temporarily stored in a bonded warehouse and for domestic use. Domestic cargo must be certified by Tanzania Medicines and Medical Devices Authority (TMDA).  For cargo in transit that goes straight across the border after entering in the country, import permit is not required.
  2. The certificate of origin helps in processing of the waiver for TMDA import permit.

Government registration certificate is required for an organisation to get duties and tax exemption.

Customs Clearance

General Information 

Customs Information

Document Requirements

Bill of lading/airway bill; Commercial invoice; Packing list. Other documents required which are obtained in Tanzania (permit documents): import permit, TRA tax exemption form, registration certificate of the organisation.

Embargoes

N/A

Prohibited Items

Medicines not in the Standard Treatment Guidelines and national essential medicines list (NEMLIT)

General Restrictions

Medicines not in the Standard Treatment Guidelines and national essential medicines list (NEMLIT)

Customs Clearance Document Requirements

Customs Clearance Document Requirements (by commodity)

 

Medicines

Medical Devices

Invoice

Yes 

( 1 copy of the original)

Yes 

( 1 copy of the original)

AWB/Bill of Lading

Yes 

( 1 copy of the original)

Yes 

( 1 copy of the original)

Authorization Letter from importer

Yes 

( 1 copy of the original)

Yes 

( 1 copy of the original)

Packing Lists

Yes 

( 1 copy of the original for each batch)

Yes 

( 1 copy of the original for each batch)

Exemption Document & Import Permit

TMDA import permit

TRA tax exemption form 265 (2 originals)  

TMDA import permit

TRA tax exemption form 265 (2 originals)  

Additional Notes

Government registration certificate is required for an organisation to get duties and tax exemption.

Transit Regime

Process is similar to the one applied for local cargo. However, some regulatory bodies such as TMDA do not apply. Transit cargo is for trucks that are going straight to the destination, such as the cargo destined for DRC. The trucks for transit cargo must be registered by TRA online system.

In general, here is the procedure to be followed by the agent for transit cargo:

  • Custom releases order, C65 and vehicle registration card must be submitted to customs wharf for generation of T1.
  • Then, copy of T1, vehicle registration card, driving license of the truck driver as well as tax invoice of the cargo have to be submitted to Delivery section of the port authority for loading permit, thereafter the truck is allowed to enter into the port and load the cargo.
  • After cargo loading, the agent submits a copy of T1, C65, passport and driving license of the driver as well as filled movement sheet to the sealing office. Customs sealing officer puts remarks on the relevant documents, seals the trucks individually and then puts the paperwork in a sealed envelope, which travels with the trucks through two checkpoints within Dar es Salaam City limits.

Note that for goods in transit, a security bond is required by the clearing agent.

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