Importing Research Materials into Zambia: ZAMRA and the ZRA

What do Zambia's Medicines and Allied Substances Act and its 2017 import regulations require for a research consignment, and what does the ZRA need at the border?

Two Zambian bodies matter to a research consignment. The Zambia Medicines Regulatory Authority, ZAMRA, administers the Medicines and Allied Substances Act of 2013 and the Importation and Exportation Regulations made under it in 2017 ^[1][2][3]. The Zambia Revenue Authority, ZRA, clears the goods through customs and assesses duty and tax.

The first question for an institutional importer is whether the material falls within the Act's definitions, and in particular whether it is an "allied substance". The answer is found in the Act itself and in ZAMRA's own guidance, not in a summary. The second question is how the consignment is documented for the ZRA. This article follows that order and writes only what the Act, the statutory instrument and ZAMRA publish.

Two authorities: ZAMRA and the ZRA

ZAMRA is the national medicines regulator. Its import and export page describes the permits it issues for the movement of regulated products in and out of Zambia ^[1]. Its legislation page lists the Act and the statutory instruments made under it ^[4].

The ZRA is the revenue authority and the customs administration. It decides on valuation, duty and tax, and it releases goods against a complete declaration. It does not decide whether a material is regulated by ZAMRA. If the ZRA considers that goods fall within ZAMRA's remit, it may ask to see ZAMRA's permit or reply before release. For that reason, the regulatory question should be answered before the goods ship.

The Act and the "allied substance" question

The Medicines and Allied Substances Act, No. 3 of 2013, is published on ZAMRA's website ^[2]. It regulates medicines and "allied substances", and it defines both terms. Everything in the import regime turns on those definitions.

This article does not paraphrase the definition. A paraphrase of a statutory definition is the kind of text that is repeated, shortened and eventually wrong. Read the definition in the Act, and read ZAMRA's import and export page alongside it. If the two do not settle whether a particular research material is caught, ask ZAMRA.

The Importation and Exportation Regulations, SI 57 of 2017

Statutory Instrument No. 57 of 2017 sets out how regulated products are imported into and exported from Zambia ^[3]. It is the instrument that gives the Act's import provisions their working detail: who may apply, what a permit covers, what accompanies an application, and the conditions attached to an import.

UNEP's legislation platform carries an index entry for the instrument, which is a useful way to confirm its title and citation ^[5]. The authoritative text is the one ZAMRA publishes. Read it in full before drafting an application, and note down the sections that govern the application form and the conditions of the permit.

ZAMRA's online permit portal and who may apply

ZAMRA's import and export page describes an online process for permit applications ^[1]. The details of registration, supporting documents and fees are on the live page and may change. Read them on the day of application and do not rely on a secondary description.

Who may apply is a question for the Regulations and for ZAMRA. Typically a regulator in this position expects an applicant to be a registered entity with a named responsible person, and may ask for evidence of premises. If an institution is unsure whether it qualifies as an applicant for a particular material, the right move is a written enquiry, not a trial application.

Premises registration and why institutions ask about it

Institutions often ask whether the premises where a material will be kept must be registered. The Act and the Regulations govern premises that deal in regulated products ^[2][3]. Whether a university laboratory that only holds research materials falls within those provisions is a legal reading and may depend on the material.

The practical answer is to ask ZAMRA directly and to record the answer. A written reply, even a short one, is worth more than an assumption when a consignment is queried at the border.

ZRA clearance: documents, valuation and the clearing agent

This article cites no ZRA publication, and the ZRA's own pages should be read for current procedures. The documents any customs administration in the region expects are broadly consistent. Prepare them as a set that agrees with itself.

1. A commercial invoice naming the supplier and consignee, with a precise description, quantity, unit value and currency.
2. A packing list that matches the invoice.
3. The transport document: airway bill, bill of lading or road consignment note.
4. The importer's tax registration and a clearing agent's authority.
5. Any ZAMRA permit or written reply that applies to the goods.
6. The classification of the goods in the tariff, which the agent will propose and the importer remains responsible for.

Valuation follows the transaction value, so an invoice with a vague description or a doubtful value is a source of delay. The tariff classification is a separate question from the ZAMRA question, and a precise description helps with both. For why the same material can be treated differently from one country to the next, see why classification differs from one country to the next.

Timing deserves a note. A permit application takes as long as the regulator takes, and the regulator's timetable is not the supplier's. Ask ZAMRA, when you write, how long a decision usually takes, and tell the supplier the earliest date on which you can accept delivery. A shipment held at the border for want of a permit is exposed to storage charges and to whatever conditions the warehouse provides.

Keep the whole exchange in one place: the enquiry, the reply, the permit, the invoice, the transport document and the customs entry. If the institution's responsible officer changes, the next person can then see why the consignment was imported the way it was, and what each authority said at the time.

Checklist before the supplier books freight

• The Act's definition of an allied substance has been read, and ZAMRA's view on the material is recorded in writing.
• Any permit that applies has been issued before the goods leave the supplier.
• A clearing agent has been named and briefed with the permit or reply.
• The invoice description says exactly what the goods are and states that they are for laboratory research use.
• A receiving officer is named, and storage is prepared at the laboratory.

The common thread is sequence. Ask first, document the answer, and only then commit the supplier to a shipment date. A consignment that arrives before its paperwork is the most expensive kind of consignment, because it sits in a customs warehouse accruing charges while the questions are answered.