By the PharmaTradz BD Team. Published November 2026.
Most pharmaceutical tenders have one condition that rules out the majority of suppliers before price is even discussed: the product must be registered in the buyer's country. Building a registration takes years, so routine national tenders tend to go to the same handful of local registration holders, round after round.
There is a second, much less crowded group of purchases where that condition is lifted or relaxed. A hospital needs a medicine that has no local registration at all. A health system is short of a product and buys an approved foreign version to bridge the gap. A UN agency or donor programme accepts any product approved by a stringent regulator or prequalified by WHO. For a manufacturer or exporter with a product approved in a well-regulated market, these purchases can be the fastest way into a new country.
This guide explains the four kinds of special-route purchase, how regulators make room for them, what buyers ask for, and how to find them. It is written for business development and regulatory teams, it is not legal advice, and every route mentioned has detailed rules that you should check with the regulator concerned.
The four kinds of special-route purchase
1. Special import of unlicensed medicines. A licensed importer or wholesaler brings in a medicine with no local marketing authorisation because a patient, or a group of patients, needs it and no registered equivalent exists. In England, regional NHS purchasing consortia run frameworks specifically for unlicensed imported medicines, including over-labelled and translated packs, and award places on them through open tenders.
2. Emergency procurement. Fast purchases after an outbreak, a natural disaster or a sudden stock-out. Timelines can be days rather than months, and the buyer weighs stock on hand and delivery speed as heavily as price.
3. Shortage purchases. Some national supply agencies publish dedicated invitations for medicines that are officially in short supply, separate from their regular tender cycle. These often accept products registered elsewhere, with conditions.
4. Tenders that accept approval elsewhere instead of local registration. Common in UN, donor-funded and humanitarian procurement, where the quality standard is WHO prequalification or approval by a stringent regulatory authority. Note that even here, products usually still have to meet the importing country's own rules, which may mean a waiver or an expedited registration rather than none at all.
How regulators make room for unregistered supply
Almost every regulator has a legal route for supplying a medicine that is not registered locally when patients need it. The names differ; the logic is the same. A licensed importer or hospital applies, the product must be approved somewhere credible, and the permission is limited in time, quantity or purpose.
| Market | Route | Who applies | Key condition |
|---|---|---|---|
| United Kingdom | Import of unlicensed medicines for special clinical needs | Licensed importer | Notification to the MHRA, which has 28 days to object (faster in clinical emergencies), with evidence of clinical need and GMP/GDP compliance |
| United States | Temporary importation during a shortage | Manufacturer or distributor, at the FDA's invitation | The foreign version is reviewed by the FDA and allowed only while the shortage lasts |
| Canada | Exceptional importation and sale | Holder of a drug establishment licence | The drug is on Health Canada's list for a critical (Tier 3) shortage; foreign labels allowed with a bilingual risk communication plan |
| Australia | Section 19A approval | Australian sponsor | The product is registered in a recognised overseas market and supplied only while the Australian product is unavailable |
| Latin America | Import of unregistered or "vital, not available" medicines | Health institution or licensed importer | Case-by-case approval by the national regulator |
| Gulf, Asia, Africa | Special import permits | Hospital or licensed importer | Usually a hospital request plus proof of registration in the country of origin |
Two points matter commercially. First, the importer of record is almost always a local licensed company, not the foreign manufacturer, so a good local partner is essential. Second, these permissions are temporary by design. Treat them as a bridge into a market, and plan the full registration in parallel if demand looks durable.
What buyers ask for
Because the usual local registration is missing, buyers lean harder on proof of quality from elsewhere. Expect to provide:
- Proof of approval in a reference market: registration in the country of manufacture, approval by a stringent regulatory authority, or WHO prequalification.
- A GMP certificate for the manufacturing site and a Certificate of a Pharmaceutical Product (CoPP).
- Batch certificates of analysis, and stability data suited to the destination's climate zone.
- Remaining shelf life at delivery, often at least 60–75%.
- Labelling in an accepted language, or over-labelling and translated patient leaflets arranged by the importer.
- Lead time and stock position. In emergency and shortage purchases, the supplier who can ship from stock usually wins.
The UK unlicensed-medicines frameworks are a good illustration. They ask bidders to hold the right licences to import and distribute unlicensed medicines and to show GMP and GDP compliance, and they score price alongside quality and social value rather than on price alone.
How to find these tenders
Special-route purchases are scattered across national portals, UN systems and hospital procurement sites, and they rarely use the same words. Search terms that help include "unlicensed", "unregistered", "special import", "shortage medicines", "emergency procurement" and "vital, not available", together with the names of the main portals: the UK Find a Tender service, the EU's TED, UNGM and national e-procurement systems.
To save you the search, PharmaTradz now collects these purchases in one place. Our special import and emergency tenders page lists open special-route tenders with the buyer, reference and closing date, each linked to the official notice. Routine tenders are in the full pharma tender calendar, and medicines in short supply are tracked on our drug shortage radar.
Is it worth pursuing?
For a company with a product approved in a well-regulated market, usually yes, with clear eyes about the trade-offs.
- Less competition: the registration barrier that filters out most bidders is gone or lower.
- Better margins are common, because buyers are paying for availability and speed.
- Smaller, irregular volumes: many orders are one-off or short-term, and permissions end when the shortage does.
- Documentation is the real work: a complete, current dossier pack (GMP, CoPP, CoA, stability, labels) wins more of these purchases than price does.
If you want to bid on a special-route tender, or need a source for a product in one, send us the product, strength, quantity and destination. We match manufacturers whose product is approved in a reference market and can supply the documents a special-import permit needs. For individual patients rather than tenders, our global guide to named-patient import programmes covers the country-by-country rules.
Frequently Asked Questions(FAQs)
What is a special import tender?
A purchase where the buyer accepts a medicine that is not registered in its own country, usually because no registered equivalent exists or the registered product is in shortage. The product must be approved somewhere credible, and a local licensed importer handles the permit.
Can a foreign manufacturer bid directly?
Sometimes, but usually the importer of record must be a locally licensed company. Most manufacturers bid through, or alongside, a local importer or wholesaler that holds the right licences.
Which documents are needed?
Typically proof of approval in a reference market or WHO prequalification, a GMP certificate, a Certificate of a Pharmaceutical Product (CoPP), batch certificates of analysis, stability data and a commitment on remaining shelf life.
Do UN and donor-funded tenders need local registration?
They usually set WHO prequalification or stringent-authority approval as the quality standard, but products must still comply with the importing country's rules, which may mean a waiver or expedited registration.
Where can I find open special import and emergency tenders?
PharmaTradz lists them on its special import and emergency tenders page, each linked to the buyer's official notice and updated weekly.
