Shortage Import Routes: Section 19A and Its Equivalents Worldwide

By the PharmaTradz BD Team. Published November 2026.

When a registered medicine runs short, patients do not stop needing it. Most regulators know this, and most have a legal route that lets a licensed local company bring in the same medicine registered in another country for a limited time, until local supply recovers. Australia calls it Section 19A. Canada has a list for exceptional importation. Colombia calls the product a "vital no disponible". The names differ but the logic is the same.

This guide is for importers, distributors, hospital buyers and tender suppliers. It explains how these shortage import routes work, what each major market requires, and what documents a supplier must have ready. Imports for a single patient are a related but different route, covered in our global guide to named patient import programs.

How shortage import routes work

Almost every scheme follows the same pattern:

• A local licensed company applies. The overseas manufacturer or trader cannot apply on its own. The applicant is a sponsor, importer, wholesaler, hospital or health ministry in the destination country.
• The product must be registered abroad, usually by a regulator the destination country trusts: the EU, UK, US, Canada, Switzerland, Australia, Japan or another stringent authority.
• The approval is temporary and specific. It covers a named product, strength and pack, often from a named source, for a fixed period or until the shortage ends.
• Foreign packs are usually accepted, sometimes with a local-language leaflet, sticker or information letter for prescribers and pharmacists.
• Price and reimbursement may differ from the local product, so buyers should check this before committing to volume.

Country by country

Australia. Under Section 19A the TGA can let an Australian sponsor supply a medicine registered in a country with a comparable regulator when the Australian product is in shortage or unavailable. Approvals are time-limited and published by the TGA. In 2026 the TGA listed several estradiol patch strengths in shortage until 31 December 2026 and had already approved overseas-registered alternatives for most of them.

New Zealand. Section 29 allows supply of a medicine without New Zealand consent to a prescriber for a particular patient, with Medsafe notified of each supply. In wider shortages the national purchaser can also arrange an alternative brand.

United Kingdom. An importer must notify the MHRA before bringing in an unlicensed medicine and must not import it if the MHRA objects within 28 days of acknowledging the notification. The notification needs evidence of special clinical need, such as proof that UK-licensed products are unavailable, plus proof that the product is licensed in its country of origin and evidence of GMP and GDP compliance. The MHRA can waive the waiting period for critical medicines.

European Union. Article 5(1) of the EU medicines directive covers special clinical needs. Article 126a lets a member state allow a medicine authorised in another member state onto its market for justified public health reasons. Each country also has its own scheme, for example individual imports by pharmacies in Germany, foreign-medicine authorisations from the AEMPS in Spain, and import authorisations from the ANSM in France. Note that some EU countries restrict the export of medicines on their national shortage lists, so the source country matters.

Canada. Health Canada keeps a List of Drugs for Exceptional Importation and Sale. A drug on the list can be imported and sold during a serious shortage if it is authorised by a trusted foreign regulator and made under GMP. For individual patients there is also the Special Access Programme.

United States. The FDA can, in rare cases, use temporary flexibility to let a foreign-approved product in during a critical shortage, as it did for some cancer medicines in 2023. This is not an open application route. The FDA chooses and assesses the manufacturer itself.

Latin America. In Colombia, Decree 481 of 2004 lets INVIMA authorise the import of an essential medicine that is not available in the country, without local registration. Brazil allows exceptional imports for the public health system under RDC 203/2017 when there is a shortage and no registered substitute, with preference for WHO-prequalified products or those approved by ICH regulators. Most other Latin American ministries issue exceptional import permits case by case, usually asking for a certificate of pharmaceutical product from the reference country.

Africa, Middle East and Asia. South Africa's Section 21 lets SAHPRA authorise the sale of an unregistered medicine for a defined purpose and period. Gulf regulators allow hospitals and tender importers to bring in unregistered medicines with a permit, often linked to a specific tender or patient group. Singapore's Special Access Route and Israel's Regulation 29 work in a similar way for medicines not registered locally.

What the supplier must provide

The applicant does the paperwork with the regulator, but the approval rests on the supplier's documents. Have these ready before you quote:

• proof of registration in the reference country, ideally a certificate of pharmaceutical product (CoPP) or a public register entry;
• a current GMP certificate for the manufacturing site from a recognised authority;
• the batch certificate of analysis, expiry date and shelf life at shipment;
• pack artwork and the approved product information, with translations if requested;
• proof that the goods come from the marketing authorisation holder or a licensed wholesaler, with a documented supply chain under GDP;
• temperature and transport records where storage conditions apply.

Products bought through unclear channels fail at this stage. Regulators and hospital buyers increasingly ask for a full chain of custody back to the authorisation holder. If you are not sure about a source, check the supplier's credentials first.

Example: estradiol patches in 2026

The 2026 estradiol patch shortage shows how these routes work in practice. Demand for menopausal hormone therapy rose sharply after the FDA asked in November 2025 for boxed warnings to be removed from these products, and patch production cannot be scaled quickly. In Australia, Section 19A approvals let sponsors supply patches registered overseas while local brands were short. Buyers in other markets used the same idea through their own routes: importing packs registered in Europe through exceptional import permits, or asking a manufacturer with existing registrations to supply under a temporary approval. The practical lesson is that the buyer who can show the regulator a clean, fully documented source gets supplied first.

Common mistakes

• Treating it as a commercial shortcut. These routes exist for shortages and unmet need. They do not replace registration, and approvals end when local supply recovers.
• Quoting before checking the reference registration. A product registered only in its home market may not qualify where a stringent reference authority is required.
• Ignoring export restrictions. A shortage in one country often means tight supply in neighbouring markets too, and some authorities limit exports.
• Short expiry and storage. Approval times eat into shelf life. Agree a minimum remaining shelf life and cold-chain handling in the contract.

How PharmaTradz helps

We help licensed importers, sponsors and hospital buyers find medicines registered in Europe and other reference markets for shortage and exceptional imports, with the documents regulators ask for.

• See which medicines are short and where on our drug shortage radar.
• Looking for estradiol patches? Send your country, strength and monthly volume on the estradiol patch page.
• Supplying a public tender? Browse open pharma tenders.
• Have a requirement now? Send your RFQ and we will come back with available registered sources.

The bottom line

Shortage import routes exist in almost every regulated market. They all need a local applicant, a product registered with a trusted regulator abroad, and a supplier who can prove where the goods came from. Prepare that documentation before the next shortage and you can respond in weeks rather than months.

This article is general business information, not legal or regulatory advice. Rules and procedures change and differ by country; check the current position with the relevant authority or a qualified adviser.

Frequently Asked Questions(FAQs)

What is Section 19A?

A provision of Australia's Therapeutic Goods Act that lets the TGA approve an Australian sponsor to supply a medicine registered in another country when the Australian product is in shortage or unavailable. Approvals are temporary.

Do other countries have something similar?

Yes. Examples include New Zealand's Section 29, UK unlicensed imports notified to the MHRA, EU Article 126a and national schemes, Canada's List of Drugs for Exceptional Importation and Sale, Colombia's "vital no disponible", Brazil's exceptional importation and South Africa's Section 21.

Can an overseas supplier apply directly?

Usually not. A licensed company or institution in the destination country applies. The overseas supplier provides the registration proof, GMP certificate, batch documents and a traceable supply chain.

Which registrations are accepted as a reference?

Most schemes prefer products approved by stringent regulators such as the EU, UK, US, Canada, Switzerland, Australia or Japan, or prequalified by WHO. Each country sets its own list, so check before quoting.

How is this different from a named patient import?

A named patient import supplies one identified patient on a prescriber's request. Shortage import routes usually cover wider supply to a market for a limited period while the registered local product is unavailable.