The EU approves the inclusion of active pharmaceutical ingredients in the trade agreement with Canada to facilitate mutual recognition of drug manufacturing standards
12 May 202678 views
Who is affected:
Pharmaceutical industry, active ingredient manufacturers and EU regulatory authorities
Summary
The EU sets its position to expand the CETA agreement with Canada by including active pharmaceutical ingredients in the mutual recognition of good manufacturing practices. This simplifies customs controls and facilitates the trade of pharmaceutical raw materials between both regions.
Detailed analysis
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The EU Council adopts the European position to modify the Protocol on mutual recognition of good manufacturing practices (GMP) of the CETA, incorporating active pharmaceutical ingredients (APIs) into the list of Annex 1. This inclusion means that inspections carried out by Canadian or European authorities on API manufa…
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CELEX:32026D1070: Decisión (UE) 2026/1070 del Consejo, de 5 de mayo de 2026, relativa a la posición que debe adoptarse, en nombre de la Unión Europea, en el Comité Mixto del CETA creado en virtud del Acuerdo Económico y Comercial Global (CETA) entre Canadá, por una parte, y la Unión Europea y sus Estados miembros, por otra, en lo que respecta a la inclusión de los ingredientes farmacéuticos activos entre los medicamentos o fármacos enumerados en el punto 2 del anexo 1 del Protocolo sobre el reconocimiento mutuo del programa de cumplimiento y control de la aplicación relativo a las normas de correcta fabricación de medicamentos
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