Food, Drugs and Cosmetics in Zanzibar: Why ZFDA and Not TMDA

This page is the island product-registration operating file: which desk registers a product and a premises for Unguja and Pemba, and what a Mainland approval is worth when the container berths. It is not a Mainland licensing guide and not the agency’s own dossier checklist.

• Fake stock in the channel: the commercial options against counterfeits
• Moving the goods across: LATRA, TASAC and who regulates what
• Growing what you process: agricultural land access for foreign investors
• Tourist supply alongside: aviation and tourist transport approvals

As at 14 September 2026. Confirm forms, the fee schedule and the registered-premises list at zfda.go.tz; this file rests on the 2006 Act for the islands and on Cap. 219 and Cap. 130 for the Mainland comparison.

Health never joined the Union list

The Constitution reserves a closed list of matters to the United Republic. Health, food safety, standards, land and trade licensing are not among them, so the Revolutionary Government legislates for Unguja and Pemba on its own account. Act No. 2 of 2006 is the result, and the agency it created opened in 2007 with one mandate over food, drugs, cosmetics and medical devices: four families the Mainland now splits between two authorities.

That split causes the argument at the port. The Finance Act, 2019 renamed the old Tanzania Food and Drugs Authority as the Tanzania Medicines and Medical Devices Authority and moved food and cosmetics to the Tanzania Bureau of Standards under the Standards Act Cap. 130. A Mainland maker of bottled juice or body lotion therefore holds a TBS certificate, and the island desk treats neither document as a registration of its own.

Cargo reaches the islands through Malindi harbour, Abeid Amani Karume International Airport and the Pemba landings at Mkoani and Wete. The officer there works from the island register, not from a framed certificate issued in Dar es Salaam.

Four product families, two jurisdictions

Who may own the trade, and where the premises may stand

Two questions close before any form is opened. The reserved-activity schedule published at GN No. 487A of 2025 is a Mainland instrument; it does not reach the islands, where the Zanzibar Investment Promotion Authority decides what a non-citizen may do. Clearance under that schedule is not clearance for Unguja, and the reverse holds too.

Land is the second. All land in Zanzibar is public land under the Land Tenure Act No. 12 of 1992, and a non-citizen takes occupation through an approved investment lease rather than by purchase. A cold store, a blending room or a bottling line is tenure-heavy, and the tenure decides whether a building permit can issue at all. The premises application names an address an inspector will walk; a borrowed corner of another trader’s godown does not survive that visit.

What the two registers actually hold

Two registers run in parallel and both must be satisfied before a sale is lawful. Premises come first: the application for registration of premises is Form 001, and a manufacturer files a separate application for a food manufacturing permit on top of it. Entries are searchable through the agency’s management information system at portal.zfda.go.tz, where a buyer, a landlord or a bank should check a supplier’s claim rather than accept a scan.

Product registration runs item by item. A dossier carries artwork as it will be printed, the full composition, the manufacturer’s free-sale certificate from the country of origin, manufacturing-practice evidence for medicines and devices, laboratory results against the applicable standard, the shelf life you intend to declare and the basis for it, and samples in retail packing. A change of formulation, pack size or production site opens a fresh decision, not a note on an existing entry.

Consignments are controlled separately again: a permit before shipment, inspection and sampling at entry, then release. Surveillance closes the loop inland, with seizure and destruction of unregistered, mislabelled or expired stock found on shelves. Charges sit in a schedule made under the Act and are paid into the agency’s People’s Bank of Zanzibar accounts, in shillings or dollars; no amount is reproduced here.

The corporate and tax file underneath

An island trade needs an island corporate record. The Business and Property Registration Agency, not BRELA, holds companies and business names there under Zanzibar’s own Companies Act, and the trade licence issues there too. A Mainland company supplying the islands does not acquire that presence by invoice.

Tax divides on the same constitutional line. Income tax is a Union head, so one taxpayer identification number from TRA serves both sides. Value added tax is not: the Zanzibar Value Added Tax Act No. 4 of 1998 is administered by the Zanzibar Revenue Authority at 15% with registration at TZS 100 million of taxable turnover, against 18% and TZS 200 million under Cap. 148. Customs is Union, so TRA clears the entry, but nothing moves while the agency’s release is outstanding, and demurrage runs against the importer.

The sequence the desks take

1. Settle the class first: food, cosmetic, device or medicine, because the answer picks the form, the dossier and the laboratory panel.
2. Close ownership and tenure: the investment route for a non-citizen, and the lease, before a deposit moves.
3. Open the island corporate file: BPRA record, trade licence, revenue registration where the threshold is met, taxpayer number carried across.
4. Register the premises: Form 001, a scaled drawing showing product flow, then inspection and the defect list it produces.
5. Register each product: one dossier per item, samples to the laboratory, the decision, then an entry you can point a buyer to.
6. Open the consignment file: the import permit before goods ship, then inspection and release at the entry point.
7. Diarise every expiry: product certificates, premises registration, manufacturing permit, trade licence and returns, each a clear month early.

Documents the file needs

Certificate of incorporation or registered branch with a current BPRA extract; the trade licence; taxpayer identification certificate; the tenure document carrying the plot as the authority spells it; the premises form and its drawing; a potability report for water used in production; a pest-control contract naming the contractor; medical examination certificates for everyone who touches product, casuals included; per item, final artwork, composition, a legalised free-sale certificate, manufacturing-practice evidence where the class demands it, test reports and samples; per consignment, pro forma invoice, packing list, bill of lading or airway bill, batch certificate of analysis and the permit; and control-number receipts for every payment.

Illustrative arithmetic: a skin-care consignment held at Malindi

An importer lands 1,800 cartons of skin-care at TZS 30,000 a carton, a landed cost of TZS 54,000,000. The range holds a Mainland standards certificate; six of its items have never been placed on the island product register. The cargo is held.

Assume storage and demurrage of TZS 150,000 a day, and 45 days to move six dossiers from a standing start to a decision. That is TZS 6,750,000, one eighth of the landed cost, spent on days rather than on approvals. Assume a contract laboratory quotes TZS 400,000 a sample: six samples come to TZS 2,400,000, and value added tax at 15% adds TZS 360,000, giving TZS 2,760,000 on the testing invoice.

Registering those six items before the order shipped would have carried the same fees and the same testing, and none of the TZS 6,750,000. Illustrative arithmetic, not a quotation: carton count, daily charge, elapsed days and sample price are assumptions, and the real panel belongs to the standard.

Where this file stalls

• A Mainland certificate offered at the port as an island registration, the container held while the argument is had
• An application posted to the medicines authority for a cosmetic that stopped being its business in 2019
• A full label run printed before artwork was assessed, so every carton carries a wrong declaration
• A free-sale certificate never legalised, or naming a production site the dossier does not
• An importer with no BPRA record applying as though it were resident
• Premises registered while three items of nine remain off the product register
• A renewal date discovered by an inspector rather than by the diary

What moved, and what did not

The confusion is a Mainland artefact. The 2019 reform split one authority into two desks there and renamed the survivor, while the island statute was left alone: same agency, same four families, same register. Traders who learned the old name still write to it.

On the revenue side the Zanzibar Revenue Board became the Zanzibar Revenue Authority, which changes the letterhead and the portal a new importer is sent to. Instruments move by Act, Government Notice and portal revision, so check forms and charges at the start of each file rather than reusing last year’s pack.

Mandate-holders this file does not replace

ZFDA registers premises and products, permits consignments, inspects at entry and polices island shelves. TMDA owns medicines, devices and diagnostics on the Mainland; TBS owns Mainland food, cosmetics and the standards mark. The Zanzibar Bureau of Standards owns island standards work, and the ministry responsible for health owns public-health enforcement beyond the product. BPRA holds the company and the licence; ZRA assesses non-Union taxes; TRA owns the taxpayer number and customs; the investment authority owns the approval and the tenure behind it.

Zatra prepares, structures and coordinates the pack, the sequence and the diary. It does not inspect premises, test samples, practise law, audit, or issue any permit, certificate or approval, and no regulatory outcome is promised.

What to confirm before you act

• The class your label puts the product in, settled before a dossier opens or artwork goes to print
• The current version of each form and the fee schedule at zfda.go.tz
• What weight the registration desk gives a foreign approval inside the dossier, before you build a timetable on it
• Whether activity and tenure are open to a non-citizen there, asked of the investment authority rather than inferred from a Mainland schedule
• That every item you intend to invoice sits on the product register, and that the premises entry covers the delivery address