Questions and Answers on Importation and Exportation under Good Manufacturing Practices – Health Canada

Purpose of the Guidance

This Q&A document clarifies the application of Good Manufacturing Practices (GMP) requirements under Division 2 of Part C of the Food and Drug Regulations to activities involving importation and exportation of drugs (including active pharmaceutical ingredients – APIs) and medical devices. It addresses common questions from industry regarding responsibilities of Canadian importers, foreign manufacturers, quality agreements, and specific importation/exportation scenarios to promote consistent interpretation and compliance. Questions and Answers: Importation and Exportation under Good Manufacturing Practices - Canada.ca

Key Principles

• Canadian importers of drugs and APIs must hold a Drug Establishment Licence (DEL) and ensure imported products are manufactured, packaged, labelled, tested, and stored in compliance with GMP.
• Foreign sites performing GMP-regulated activities for the Canadian market must be named on the DEL and comply with equivalent GMP standards (assessed via inspection or reliance on recognized foreign authorities).
• Quality agreements between importers and foreign sites must clearly define responsibilities for GMP compliance.
• GMP applies to the point of entry into Canada; subsequent distribution must also comply.

Common Questions and Answers

Q1: Who is responsible for GMP compliance when importing drugs?

A: The Canadian importer (DEL holder) is ultimately responsible for ensuring that imported drugs meet GMP requirements at the time of importation. This includes verifying that foreign manufacturers comply with Division 2 GMP or equivalent standards.

Q2: Do foreign manufacturers need a Canadian DEL?

A: No, foreign manufacturers do not require a DEL. However, they must be listed on the importer’s DEL, and their GMP compliance must be demonstrated (e.g., through Health Canada inspection, reliance on MRA partners, or other acceptable evidence).

Q3: What is required for importing APIs?

A: APIs imported for use in drug manufacturing require the importer to hold a DEL. The foreign API manufacturer must comply with GMP (Division 2 or ICH Q7 equivalent), and a quality agreement is recommended to define responsibilities.

Q4: Are there exemptions for investigational drugs or samples?

A: Investigational drugs imported under a Clinical Trial Application are subject to specific GMP provisions (C.05.001–C.05.015). Small quantities for testing or research may qualify for exemptions under certain conditions.

Q5: What about transit or bonded warehouse storage?

A: Products in transit or stored in bonded warehouses without entering the Canadian market are generally not subject to GMP requirements until released for sale or use in Canada.

Q6: Can personal importation occur?

A: Limited personal importation of drugs for individual use is permitted under specific conditions (e.g., prescription, small quantity, not for resale), but GMP compliance is not required for such non-commercial importation.

Q7: How are medical devices handled differently?

A: Importers of Class II, III, and IV devices require an MDEL. Foreign manufacturers must demonstrate compliance with Canadian GMP (ISO 13485-based), typically through the importer’s quality system oversight.

Practical Implications

• Importers must maintain documentation demonstrating foreign site GMP compliance (e.g., inspection reports, quality agreements).
• Health Canada may inspect foreign sites or rely on recognized foreign regulatory authorities (e.g., via Mutual Recognition Agreements).
• Non-compliance can result in import refusal, product detention, licence suspension, or other enforcement actions.

This Q&A supports stakeholders in understanding and meeting GMP obligations for cross-border activities. Full questions, detailed answers, references to regulations, and related guidance links are available in the official Health Canada document. Questions and Answers: Importation and Exportation under Good Manufacturing Practices - Canada.ca