How to Start a Pharmaceutical Import Business: Licences, Registration and Suppliers (2026)

By Mitul Agarwal, B.Pharm, MBA. Published October 2026.

Short answer: to start a pharmaceutical import business you need four things in place before the first shipment: a registered company with the right drug licences (usually a wholesale or import licence and a qualified pharmacist or responsible person), a storage and distribution set-up that meets Good Distribution Practice, products that are registered in your country or legally importable under an exemption, and GMP-certified suppliers with the documents your regulator asks for. Registration is usually the longest step, so choose products and suppliers early.

Step 1: Choose your business model

The licences you need, the money you tie up and the time to first sale all depend on how you plan to sell:

• Importer and distributor of registered brands: you represent a manufacturer whose products are, or will be, registered in your country. This is the most common model.
• Marketing authorisation holder (MAH): you hold the registration in your own name, often for products made for you under contract or white label. You carry more regulatory responsibility, but you own the market access. See our white-label manufacturing service.
• Tender supplier: you bid for government and hospital tenders. Product registration and supplier documents decide whether a bid is accepted. See our tender supply service.
• Named-patient or special-import supplier: you import medicines not registered locally, for specific patients or hospitals, under the country's exemption rules. Volumes are small and every order is documented. See the global guide to named-patient import programs.

Step 2: Set up the company and get the licences

Requirements differ by country, but most regulators ask for:

1. A registered company with drug trading or import as a stated activity, plus the general import registration that customs requires.
2. A drug wholesale or import licence from the national medicines regulator.
3. A named accountable person: usually a registered pharmacist who is responsible for storage, distribution and recalls. In the EU and UK, a wholesaler names a Responsible Person, and importing from outside the EEA or UK also needs an import authorisation and a Qualified Person who certifies each batch.
4. Approved premises: a warehouse inspected against Good Distribution Practice (GDP), with temperature mapping and monitoring, and cold storage if you will handle vaccines, insulin or biologics.
5. Separate licences for controlled substances, which this guide does not cover.

Example: India. An importer needs a wholesale drug licence from the state authority, an Importer Exporter Code (IEC) from DGFT, and an import licence (Form 10) from CDSCO. Before the import licence is issued, the overseas manufacturer and each product must hold a registration certificate (Form 41). A new drug needs CDSCO approval under the New Drugs and Clinical Trials Rules, 2019, before it can be imported for sale.

Our directory of drug regulators links to the licensing pages of each national authority.

Step 3: Get the products registered

In almost every country, a medicine must hold a marketing authorisation before it can be sold. This is where most of the time goes:

• Who files: the manufacturer, through a local agent, or you as the local MAH.
• What is filed: a dossier, usually in CTD or ACTD format, with the drug substance and drug product data, bioequivalence data for most oral generics, labels in the local language and certificates such as the CoPP (Certificate of a Pharmaceutical Product) and GMP certificate. See CTD vs ACTD.
• How long: from a few months under reliance or fast-track routes to several years for a full review. Many countries now fast-track products already approved by a stringent regulator or prequalified by WHO.

Our regional import guides hub compares registration routes, tender systems and special-import rules across 45 countries.

Step 4: Choose and verify suppliers

• Start with the documents. Ask for the GMP certificate, the CoPP for your destination, a sample CoA and the dossier format available. Check the GMP certificate with the authority that issued it.
• Match approvals to your market. A WHO-GMP site suits many emerging markets; some regulators and tenders require EU-GMP, US FDA or PIC/S approval.
• Check stability for your climate. Hot, humid countries (ICH zone IVb) need stability data at 30°C/75% RH.
• Agree terms in writing: a distribution or supply agreement (territory, exclusivity, minimum volumes, registration costs) and a quality agreement (complaints, recalls, change notification).

Our guides to verifying a pharmaceutical supplier and writing an RFQ that gets quoted cover this step in detail.

Step 5: Plan logistics, customs and payment

• Incoterms: agree who pays freight and insurance and where risk passes (FCA, CIP or DAP for air freight; FOB or CIF for sea freight).
• Customs: finished medicines are mostly classified under HS chapter 30. Check duty, VAT and any pre-shipment inspection or import permit for each consignment.
• Temperature control: cold-chain products need validated packaging and data loggers from factory to warehouse. See our cold-chain logistics service.
• Payment: letters of credit are common for first orders; advance payment and open account follow as trust builds.
• Shelf life: agree the minimum remaining shelf life on arrival. Tenders often set a minimum, so check it before you order.

Step 6: Run it compliantly

• Batch records and traceability: know which batch went to which customer, so you can recall quickly.
• Pharmacovigilance: report adverse events as your licence and the MAH's obligations require.
• Price rules: many countries control medicine prices or margins. Check before you quote.
• Renewals: licences, registrations and GMP certificates expire. Track the dates.

Common mistakes to avoid

1. Paying a supplier before checking its GMP certificate with the issuing authority.
2. Importing before the product is registered, or under the wrong exemption.
3. Choosing a supplier whose approvals do not match your regulator or tender rules.
4. Skipping a quality agreement, then finding nobody is responsible for a recall.
5. Underestimating registration time and cost, and running out of cash before the first sale.

How PharmaTradz can help

PharmaTradz connects importers with GMP-certified manufacturers, mainly in India, and helps with the documents that registration and tenders need: CoPP, GMP certificates, CoAs and dossiers through our dossier licensing and registration service. Tell us your country, your products and your business model: send an RFQ. Our buyer's checklist from inquiry to import covers the full process.

Frequently Asked Questions(FAQs)

What licences do I need to import medicines?

Usually a company registration and customs import code, a drug wholesale or import licence from the medicines regulator, approved storage premises and a qualified pharmacist or responsible person. The products themselves must also be registered or covered by an exemption.

Can I import medicines that are not registered in my country?

Only under a legal exemption, such as a named-patient, compassionate-use or special-import programme, and usually only against a prescription or hospital request. Regular commercial sale needs registration.

How long does it take to start a pharma import business?

Company set-up and licences often take a few months. Product registration takes longer: from a few months under fast-track or reliance routes to several years for a full review, depending on the country.

What licences does a pharma importer need in India?

A wholesale drug licence, an Importer Exporter Code and a CDSCO import licence in Form 10. The overseas manufacturer and its products need a registration certificate in Form 41 first.

Do I need to be a pharmacist to start a pharma import business?

Not always as the owner, but most countries require the business to employ a qualified pharmacist or responsible person who is accountable for storage, distribution and recalls.