Seek licensing through Health Canada. This involves a rigorous application process, including detailed information on your company’s structure, personnel qualifications, and proposed operations. Expect thorough facility inspections to ensure compliance with Good Distribution Practices (GDP) for pharmaceutical products.
Good Distribution Practices (GDP) Compliance
Strict adherence to GDP is mandatory. This includes maintaining accurate inventory records, employing qualified personnel, and establishing robust procedures for handling, storing, and distributing pharmaceuticals. Regular audits are common. Invest in a comprehensive quality management system to streamline compliance.
Personnel Requirements
Your team needs qualified individuals with relevant experience in pharmaceutical wholesale. Health Canada specifies minimum requirements for personnel qualifications, including education and experience. Thorough training on GDP and relevant regulations is vital for all staff.
Record Keeping and Reporting
Maintain meticulous records of all transactions, including inventory movements, shipments, and returns. Accurate record-keeping is crucial for audits and demonstrating compliance. Invest in a reliable record-keeping system that ensures data integrity and readily provides reports when required.
Ongoing Compliance
Regulations evolve. Stay informed through Health Canada’s website and industry publications. Regular internal audits and external consultations with regulatory experts are recommended to ensure long-term compliance. Proactive compliance minimizes potential risks and penalties.
Provincial Regulations
Remember that provincial regulations may add further requirements. Check with the relevant provincial health authorities for specific licensing and operational guidelines in your province of operation. Failing to comply with provincial rules can lead to sanctions.
Consequences of Non-Compliance
Non-compliance can result in significant penalties, including license suspension or revocation. Protecting your business requires constant vigilance in meeting all regulatory requirements. This includes actively seeking updated information and investing in compliance training for staff.
