EU Third-Country API Lists and Written Confirmation: What Changes on 15 November 2026

If your company makes or imports finished medicines, the active pharmaceutical ingredient is the part regulators watch most closely. In the European Union, every active substance imported from outside the bloc must be covered by a written confirmation from the exporting country's authority, unless that country sits on a short list of recognised third countries. On 15 November 2026 two separate changes to that system take effect on the same day, and both touch supply chains that Canadian manufacturers depend on.

The first change adds Singapore to the European Union's recognised list, which removes the written confirmation requirement for active substances made there. The second is a Swissmedic rule that requires active substances to be pre-registered in a European database before they can appear on Swiss establishment licences and GMP certificates. Neither change is dramatic on its own, but together they are a useful prompt to check that your active substance supply chain is documented, qualified and ready for an inspection. This guide explains what a written confirmation is, who is on the recognised list, what changes on 15 November, and what Canadian manufacturers should do.

What is a written confirmation for active substances?

A written confirmation is a document issued by the competent authority of a non-EU country that exports an active substance to the European Union. It confirms that the manufacturing site applies good manufacturing practice standards at least equivalent to those of the EU, that the site is subject to regular and transparent inspection, and that the authority will inform the EU if it withdraws that finding. The requirement comes from the Falsified Medicines Directive and is reflected in Article 46b of Directive 2001/83/EC. Why it matters: without a valid written confirmation, an active substance from a non-listed country cannot lawfully be imported into the EU. What to do: know, for every active substance you import or supply, whether its country of origin is on the recognised list or whether a written confirmation is required.

The requirement is waived for a limited set of third countries and territories that the European Commission has assessed as having a regulatory framework equivalent to the EU. For those countries, the exporting authority's oversight is accepted in place of a product-by-product written confirmation. The assessment looks at the country's GMP rules, its inspection system and its enforcement powers, and it can take many months to complete.

The EU list of recognised third countries, and who is on it

What it is: the list, established by Commission Implementing Decision 2012/715/EU, of countries whose active substance exports do not need a written confirmation. Why it matters: being on the list is a trade advantage for a country's manufacturers, and knowing who is on it tells you which of your suppliers need a written confirmation. What to do: match each active substance supplier to the current list before you rely on it.

The list is not static. Countries apply, the Commission assesses them, and the list grows. New Zealand's assessment is currently on hold pending clarification of an existing mutual recognition agreement, so it is not on the list. Every addition is made by a Commission Implementing Decision published in the Official Journal of the European Union, which is the authoritative record.

Two changes landing on 15 November 2026

Singapore joins the recognised list

On 23 October 2026 the European Commission adopted Commission Implementing Decision (EU) 2026/2347, which amends Decision 2012/715/EU to add the Republic of Singapore to the recognised list. It was published in the Official Journal on 26 October 2026, with a date of effect of 15 November 2026. From that date, active substances manufactured in Singapore can be imported into the EU without a written confirmation, provided the Singapore authority continues to supervise the site. For companies that source active substances from Singapore, this removes a recurring administrative step.

Swissmedic requires SMS pre-registration

Separately, Swissmedic has announced that, as of 15 November 2026, active substances must be registered in advance in the European Medicines Agency's Substance Management Services (SMS) database before Swissmedic can include them in establishment licences and GMP certificates. The change follows modifications to the EudraGMDP database. In practice, a manufacturer of active substances listed in section 3.8 of a Swiss establishment licence must ensure each substance is registered in SMS, with its name and SMS identifier, before Swissmedic will issue or amend the licence or certificate. The requirement applies to first-time applications and to changes made after an inspection.

What this means for Canadian manufacturers

Canada has been on the EU recognised list since early 2023, so active substances manufactured in Canada can be exported to the EU without a written confirmation. That is a genuine advantage for Canadian active substance producers. The flip side matters just as much. If your Canadian company makes or imports finished products and sources active substances from a country that is not on the list, you are responsible for ensuring a valid written confirmation is in place before those products reach the EU, and for qualifying the supplier under Canadian rules regardless of the EU position.

Health Canada's good manufacturing practices already require you to establish the identity and quality of every active ingredient you receive, and to qualify the suppliers and fabricators behind it. The EU written confirmation regime does not replace that obligation, it sits alongside it. A Canadian importer that relies on a distributor's assurance, without its own supplier qualification and testing, is exposed under both systems. If you import foreign-authorized drugs, our guide to designated drugs on a drug establishment licence explains the related Canadian expectations.

How to qualify your API supply chain

What to do: build a simple, defensible map of every active substance, its country of origin, its status against the EU recognised list, and its supplier qualification evidence. Then act on the gaps. Why it matters: most supply-chain findings are not caused by a bad supplier, they are caused by missing paperwork and an approved supplier list nobody can justify.

Map every active substance to its source country status

Start with a register that lists each active substance, its manufacturing site, the country of origin and whether that country is on the EU recognised list. For non-listed countries, record the written confirmation reference and its validity. This single register answers most inspector questions in one page and shows you where to focus.

Qualify the supplier regardless of list status

Being on the recognised list removes the written confirmation step, it does not remove your duty to qualify the supplier. You still need a signed quality agreement, evidence of GMP status, and oversight proportionate to the risk of the material. Our guide to building a supplier qualification programme sets out risk tiering, quality agreements and audit depth, and our audit services can run the supplier audits that a strong programme depends on. The same discipline protects you under FDA rules, where supplier oversight is a standing enforcement theme.

Keep your licence and database records clean

If you hold or rely on EU or Swiss establishment licences, make sure the active substances they list are correctly registered in the EMA SMS database, with the exact substance name and identifier. Data mismatches between your licence, your GMP certificate and the SMS record are an avoidable cause of delay. For a wider view of the EU GMP changes arriving through 2028, see our EU GMP guide revisions roadmap, and for API qualification lifecycle expectations, our guide to the Annex 15 revision.

A worked example: one importer, two source countries

Consider a Canadian company that imports a finished sterile injectable for the Canadian market and also exports a second product into the European Union. The injectable uses an active substance made in the United States. The export product uses an active substance made in a country that is not on the EU recognised list. On paper the company looks compliant, because both suppliers hold certificates and send a certificate of analysis with every lot. In practice, an inspector finds two gaps in an afternoon.

For the United States active substance, the company assumed that because the United States is on the EU recognised list, no further action was needed. The inspector agreed that no written confirmation was required, but asked for the company's own supplier qualification file. There was no signed quality agreement and no record of a risk-based audit decision, so the approved supplier entry could not be justified. For the non-listed active substance, the company had relied on its distributor to manage EU import. No written confirmation was on file, and the distributor could not produce one quickly, which put the next European shipment at risk.

The fix was straightforward once the gaps were visible. The company built a one-page supply-chain register that mapped each active substance to its site, its country of origin, its EU list status and its qualification evidence. It put a signed quality agreement in place for the United States supplier and scheduled a risk-based audit. For the non-listed supplier, it obtained the written confirmation from the exporting authority and recorded its validity. None of this was difficult, it was simply undone until someone was accountable for the register. That is the lesson of almost every supply-chain finding.

Common mistakes

• Assuming a written confirmation is never needed because a distributor handles import. The legal responsibility to hold it still falls on the importer.
• Treating a country's listing as permanent. The list changes, and a listing can in principle be suspended, so check the current Official Journal position.
• Confusing the EU written confirmation regime with Canadian GMP supplier qualification. You need both, and one does not satisfy the other.
• Letting licence, GMP certificate and SMS records drift out of alignment, which can delay Swiss licence actions from 15 November 2026.
• Qualifying a supplier once and never re-evaluating, so the approved supplier list cannot be justified at inspection.
• Relying on the active substance manufacturer's word without your own identity testing and documented oversight.

Compliance checklist

• Every active substance is mapped to its manufacturing site and country of origin.
• Each country of origin is checked against the current EU recognised third-country list.
• A valid written confirmation is held for every active substance imported into the EU from a non-listed country.
• Singapore-sourced active substances are treated as list-exempt from 15 November 2026.
• Active substances on any Swiss establishment licence are registered in the EMA SMS database with the correct name and identifier.
• Every active substance supplier has a signed quality agreement and current GMP evidence.
• Supplier oversight depth matches the risk of the material and is re-evaluated on a defined cycle.
• Canadian GMP supplier qualification and identity testing are in place regardless of EU list status.
• A single supply-chain register links all of the above for inspection.

Frequently asked questions

What is a written confirmation for an active substance?

It is a document from the competent authority of a non-EU exporting country stating that the active substance manufacturing site meets GMP standards at least equivalent to the EU, is regularly inspected, and will be reported to the EU if the finding is withdrawn. It is required under the Falsified Medicines Directive, reflected in Article 46b of Directive 2001/83/EC, for active substances imported into the EU from countries that are not on the recognised list.

Which countries are on the EU recognised third-country list?

As of November 2026 the list includes Switzerland, Australia, Japan, the United States, Israel, Brazil, South Korea, Canada, Taiwan and, from 15 November 2026, Singapore. New Zealand's assessment is on hold. Every addition is made by a Commission Implementing Decision published in the Official Journal, which is the authoritative source.

Does Canada being on the list help Canadian manufacturers?

Yes. Because Canada is on the list, active substances made in Canada can be exported to the EU without a written confirmation, which removes an administrative step for Canadian active substance producers. It does not change your obligation to qualify your own suppliers and to meet Health Canada GMP requirements.

What is changing at Swissmedic on 15 November 2026?

From that date, active substances must be registered in advance in the EMA Substance Management Services database before Swissmedic can list them in establishment licences and GMP certificates. The change affects manufacturers of active substances whose substances appear in section 3.8 of a Swiss establishment licence, and it applies to new applications and to changes after an inspection.

Do I still need to qualify an API supplier if its country is on the list?

Yes. The recognised list only removes the EU written confirmation step. It does not remove your own supplier qualification, quality agreement, GMP evidence and risk-based oversight duties, which apply under EU, Canadian and FDA rules alike.

Where can I confirm the current list and decisions?

The European Commission publishes the recognised list and the status of applications on its falsified medicines pages, and every listing decision appears in the Official Journal of the European Union through EUR-Lex. Always confirm the current position there before you rely on a country's status.

How MFLRC can help

MFLRC helps manufacturers and importers build active substance supply chains that hold up under inspection in Canada, the United States and Europe. We map your active substances to their country status, confirm whether a written confirmation is required, build or strengthen your supplier qualification programme, and run the supplier audits that back it up. We also help align licence, GMP certificate and database records so an administrative mismatch never delays a shipment. Explore our regulatory affairs, licensing and import and export services and audit services, or review your readiness with our Health Canada GMP self-assessment.

Conclusion

The two changes arriving on 15 November 2026 are a reminder that an active substance supply chain is only as strong as the paperwork behind it. Singapore joining the recognised list removes a step for some companies, while the Swissmedic database rule adds one for others. For Canadian manufacturers the steady message is this: Canada's place on the EU list is an advantage worth protecting, your duty to qualify suppliers never goes away, and a single, current supply-chain register is the simplest way to prove both. Get that register right and these regulatory shifts become routine rather than risk.

Sources and references

• European Commission, Importation of active substances - Listing of third countries
• European Commission, Falsified medicines
• EUR-Lex, Commission Implementing Decision (EU) 2026/2347 of 23 October 2026 (inclusion of Singapore)
• Swissmedic, Prior registration of active substances in the EMA SMS database for establishment licences and GMP certificates (1 October 2026)
• Swissmedic, SwissGMDP database