Expanding Canada‑EU Medicine Trade Rules to Cover Active Ingredients

Summary

• The European Commission proposes that the EU Council adopt a position in the CETA Joint Committee to include active pharmaceutical ingredients (APIs) as medicinal products in the GMP Protocol (the protocol that recognises good manufacturing practices for drugs).
• CETA (Comprehensive Economic and Trade Agreement) was signed on 30 October 2016 and has been provisionally applied since 21 September 2017.
• The GMP Protocol is part of CETA and aims to make it easier for medicines and drugs to be traded between Canada and the EU by recognising each other’s GMP certificates.
• The Joint Committee, set up under Article 26.1 of CETA, can agree on amendments to the protocol.
• In 2018 Canada asked to be recognised as a country that protects public health for active substances exported to the EU.
• The Commission reviewed Canada’s system, did an on‑site audit in June 2022, and in January 2023 amended the list of recognised third countries to include Canada.
• Health Canada also assessed EU authorities and confirmed that the two systems are equivalent.
• On 15 December 2022 the Joint Sectoral Group (a sub‑group of the Joint Committee) recommended that APIs be added to the operational scope of the GMP Protocol.
• The proposed decision will support that recommendation, making the inclusion of APIs binding under international law once Canada completes its internal procedures.
• The legal basis for the decision is Article 218(9) of the Treaty on the Functioning of the European Union (TFEU) and Article 207(4) TFEU.
• The decision will be published in the Official Journal of the European Union after it is adopted.
• The draft decision (to be adopted by the Joint Committee) will amend Annex 1 of the GMP Protocol by adding “(h) active pharmaceutical ingredients.” and will enter into force on the first day of the second month after Canada notifies the EU that it has finished its internal requirements.

Broader context

The Comprehensive Economic and Trade Agreement (CETA) is a landmark trade deal between the EU and Canada, designed to boost trade and investment by removing most tariffs and simplifying regulatory cooperation. The GMP Protocol (Good Manufacturing Practices) is a key part of CETA, ensuring that medicines and drugs traded between the EU and Canada meet high safety and quality standards. By recognizing each other’s GMP certificates, both sides avoid duplicate inspections, making it faster and cheaper to bring medicines to market.

This proposal builds on years of cooperation: Canada requested recognition for its active pharmaceutical ingredients (APIs) in 2018, and after audits and assessments, the EU confirmed Canada’s system meets its standards. The inclusion of APIs in the GMP Protocol means that the raw materials used to make medicines will now also be covered by this mutual recognition, further streamlining trade.

Impact on people living in the EU

For people in the EU, this change means faster access to medicines that rely on APIs imported from Canada. Since APIs are the key ingredients in many drugs, recognizing Canada’s standards ensures these ingredients meet EU safety requirements without extra checks. This can help prevent shortages, lower costs, and speed up the availability of new or existing treatments. It also reinforces trust in the safety and quality of medicines, as both the EU and Canada have confirmed their systems are equivalent.