ZAMRA product registration and a Zambia-licensed wholesaler are both required before Indian medicines can be sold in the country.

ZAMRA is Zambia's medicines regulator, not a customs formality

The Zambia Medicines Regulatory Authority (ZAMRA), formerly the Pharmaceutical Regulatory Authority, is the statutory body established under the Medicines and Allied Substances Act No. 3 of 2013. Its mandate covers the manufacture, importation, storage, distribution, supply, sale and use of medicines and allied substances in Zambia.

That mandate matters for an Indian exporter because it means three separate approvals sit under ZAMRA, and all three need to be in place before a consignment can move: the product itself needs a Marketing Authorisation, the Zambian party receiving it needs a premise licence, and the shipment needs an import permit. A product being registered elsewhere, including in India, does not substitute for any of these.

Product registration: Marketing Authorisation, not a courtesy listing

ZAMRA registers human medicines, veterinary medicines, allied substances and cosmetics separately, each with its own Marketing Authorisation Holder (MAH) record. Applications and renewals run through ZAMRA's e-Services portal, and the Authority publishes registers of valid, expired and withdrawn Marketing Authorisations for each category, so a buyer can check a product's current status before placing an order.

For an Indian exporter, this means the dossier work happens well before the first shipment: product information, manufacturing and quality data, and labelling all need to satisfy a Zambian reviewer, not just an Indian one. M Care Exports supports this stage directly, coordinating dossier preparation with the manufacturer so the file a Zambian applicant submits is consistent with what CDSCO and the state licensing authority already hold in India. See our dossier preparation service for how that file gets built.

ZAMRA's own published material does not describe a reliance route that substitutes WHO prequalification, or another regulator's approval, for its own review. Treat Zambian registration as a national process in its own right rather than an extension of any other listing. For the general distinction between the two routes, see WHO prequalification versus national registration.

Only a ZAMRA-licensed wholesaler can hold the import and receive the goods

ZAMRA licenses premises separately from products. Wholesale pharmacies are the category that covers procurement, storage and distribution of medicines to authorised institutions and retailers within Zambia's pharmaceutical supply chain, and ZAMRA inspects them for storage conditions, quality management systems, distribution practice and record-keeping. Hospital and retail pharmacies, agro-veterinary shops and health shops are licensed under their own separate categories.

• An Indian exporter cannot hold a Zambian import permit directly. The importing party of record has to be a ZAMRA-licensed wholesale pharmacy, hospital pharmacy, or another premise category the Authority recognises for that product type.
• M Care Exports ships against the licensed importer's own permit and paperwork, supplying the manufacturer-side documents that importer needs to support its application and its ongoing ZAMRA compliance record.
• For hospital and tender buyers who have not yet confirmed which licensed importer will receive a given order, that is worth settling before a quotation is finalised, since the permit and the registration both attach to that party.

Import and export permits sit alongside product registration

ZAMRA's Import and Export section issues the permits and authorisations that allow registered medicines, medical devices and cosmetics to cross Zambia's borders, and it works with customs and border agencies to stop counterfeit, substandard, falsified or unauthorised products entering the country. In practice this means a registered, correctly labelled product still needs its own import authorisation before a specific shipment can clear.

ZAMRA's published guidance describes permits at consignment level rather than a single blanket authorisation covering all future shipments of a product, in line with how most national regulators in the region handle import control. Confirm the current permit validity period and application lead time directly with ZAMRA's e-Services portal or the licensed Zambian importer before booking a shipment, since permit terms are the kind of detail regulators revise without much notice. The same consignment-level pattern appears in Kenya's PPB import control and Ethiopia's EFDA process, both worth reading alongside this one if a shipment is routing through more than one East or Southern African market.

One more Indian-side step was announced and then paused. In September 2025 ZAMRA notified Indian exporters, through Pharmexcil, that every pharmaceutical consignment with a bill of lading dated on or after 1 October 2025 would need pre-shipment document verification, physical inspection and testing in India, and a Clean Report of Inspection and Analysis (CRIA) issued by its designated agency, Quntrol Laboratories. Before it started, ZAMRA postponed the exercise until further notice (Pharmexcil circular, 25 September 2025), and ZAMRA's import page does not list it as of October 2026. It can return with a new start date, so check the latest Pharmexcil and ZAMRA notices before booking a first shipment, and allow time for inspection and testing in the plan if it is back in force.

ZAMMSA runs public-sector procurement; ZAMRA regulates the product

The Zambia Medicines and Medical Supplies Agency (ZAMMSA) is a separate statutory body, established under the Zambia Medicines and Medical Supplies Agency Act 2019, with the mandate to procure, store and distribute medicines and medical supplies to public health institutions across Zambia on behalf of the Zambian government. It is Zambia's public-sector buyer and logistics agency, not a medicines regulator, and it runs its own tenders, adverts and notices through an e-government procurement system, alongside a national warehousing and distribution network.

For a supplier, the practical separation is this: ZAMRA decides whether a product and its importer are legally allowed onto the Zambian market at all; ZAMMSA decides which registered products it buys for public hospitals and clinics, and on what tender terms. A product needs ZAMRA registration before it can feature in a ZAMMSA tender submission. M Care Exports prepares tender documentation and pricing for public procurement processes of this kind; our tender response support covers the document assembly and compliance checks that a submission like this needs, even where the buyer sits outside the Gulf.

The Indian-side document pack a Zambian registration file needs

Whichever route a buyer takes, whether direct import against a licensed wholesaler's permit or a ZAMMSA tender, the underlying Indian paperwork is largely the same. M Care Exports assembles this pack from the manufacturer for every Zambia-bound enquiry:

1. Certificate of Pharmaceutical Product (CoPP) in WHO format, issued by CDSCO or the relevant state licensing authority, confirming the product is licensed for sale in India.
2. Manufacturing licence and current GMP certificate for the manufacturing site, issued by the state drug licensing authority.
3. Certificate of Analysis (CoA) for the specific batch being supplied.
4. Free Sale Certificate where the importing party or tender specification requires one.
5. Product labelling and package insert artwork, for review against ZAMRA's own labelling requirements before the registration dossier is filed.
6. Commercial documents: proforma invoice, packing list and the exporter's Import Export Code (IEC) details for customs clearance on the Indian side.

M Care Exports supplies both originator brands, sourced through licensed Indian distribution channels, and generics from WHO-GMP certified manufacturing partners. We do not manufacture and do not hold WHO-GMP status ourselves; the certificate always names the manufacturing site. Buyers evaluating a specific molecule or brand for the Zambian market can start with our product enquiry form, or set up a trade account to move straight to quotation once the licensed Zambian importer is confirmed.

For how we route supply into Southern and East Africa, including the overland corridor from Durban into Zambia, see our Africa market overview.

Frequently asked

Does a medicine need ZAMRA registration before it can be imported into Zambia?

Yes. ZAMRA's mandate under the Medicines and Allied Substances Act covers the importation, storage, distribution, supply and sale of medicines in Zambia, and product registration through Marketing Authorisation sits at the centre of that. A product without a valid Marketing Authorisation, or one whose authorisation has expired or been withdrawn, is not legally saleable in Zambia regardless of its status in India or any other market. Check ZAMRA's published registers of valid, expired and withdrawn Marketing Authorisations before quoting a firm delivery date to a buyer.

Can M Care Exports import directly into Zambia without a local partner?

No. ZAMRA licenses the premises that are allowed to import, store and distribute medicines within Zambia, including the wholesale pharmacy category that covers this kind of commercial supply chain. An Indian exporter is not itself eligible for that licence. M Care Exports ships against the import permit and premise licence of a ZAMRA-licensed Zambian wholesaler, hospital pharmacy or equivalent, and supports that party with the manufacturer-side documentation its own application and ongoing compliance record require.

Is an import permit a one-time approval or does it apply per shipment?

ZAMRA's Import and Export section issues permits and authorisations for the movement of regulated products across Zambia's borders, and its guidance frames this at the level of the individual shipment rather than as an open-ended clearance for a product. Treat each consignment as needing its own current permit, and confirm validity periods and lead times with ZAMRA's e-Services portal or the licensed Zambian importer before finalising shipping dates, since these operational details change without much public notice.

What is the difference between ZAMRA and ZAMMSA?

ZAMRA is Zambia's medicines regulator: it registers products, licenses pharmacies and wholesalers, and issues import and export permits. ZAMMSA, the Zambia Medicines and Medical Supplies Agency, is a separate statutory body established in 2019 to procure, store and distribute medicines and medical supplies to public health institutions on the government's behalf. ZAMRA decides what can legally be sold in Zambia; ZAMMSA decides what the public sector buys, through its own tenders. A product needs ZAMRA registration before it can be offered into a ZAMMSA tender.

Does WHO prequalification remove the need for ZAMRA registration?

No, not based on what ZAMRA publishes. Its registration process is described as a national review in its own right, and we have not found published ZAMRA guidance naming a reliance route that substitutes WHO prequalification, or another regulator's approval, for its own dossier assessment. WHO prequalification remains useful for eligibility in donor-funded procurement such as UNICEF or Global Fund tenders, but it runs alongside ZAMRA registration rather than replacing it. See our note on WHO prequalification versus national registration for the general distinction.

What documents should we expect from an Indian supplier for a Zambian registration file?

A Certificate of Pharmaceutical Product in WHO format from CDSCO or the state licensing authority, the manufacturing site's current GMP certificate, a batch-specific Certificate of Analysis, a Free Sale Certificate where required, and labelling and package insert artwork for review against ZAMRA's own requirements. M Care Exports assembles this pack from the manufacturer for every Zambia-bound enquiry, alongside the commercial documents customs clearance needs on the Indian side.