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

CETA is a big trade deal between the EU and Canada that cuts business barriers and boosts trade in goods like medicines. The GMP Protocol inside CETA lets both sides trust each other's checks on how drugs are made safely, avoiding repeat inspections. Adding APIs—key ingredients that make medicines work—expands this trust after audits confirmed both countries' systems match up. data.consilium.europa

Impact on People Living in the EU

EU residents get steadier medicine supplies since Canadian APIs face fewer import hurdles, helping avoid shortages. Drug companies save money on double checks, which can keep medicine prices lower over time. Safety stays high because both sides agree the quality rules are equal. data.consilium.europa

Impact on People Living in Canada

Canadians gain from EU APIs entering easier, supporting reliable drug access there too. It balances trade by having Canada now trust EU checks on APIs, just as the EU trusts Canada's. canada

Key Benefits

This cuts repeat inspections, frees regulators to check riskier makers elsewhere, and smooths pharma trade. The change starts two months after both sides finish paperwork. international.gc