Our health law practice involves advising on every aspect of a regulated business including:
- clinical trial agreements and commercial agreements with wholesalers, distributors, retail pharmacies and other third parties;
- regulatory submissions for approval to Health Canada;
- pre-Notice of Compliance materials for healthcare professionals, product launches, post-approval marketing materials (including detail aids, physician restricted websites, disease state material, and television/radio/ print advertising) and compliance with product labeling laws; responses to buying group and hospital requests for proposals (“RFPs”);
- Patented Medicine Prices Review Board (PMPRB),formulary reimbursement and product listing agreements;
- complaints relating to compliance with the Food & Drugs Act, Competition Act, Pharmaceutical Advertising Advisory Board Code of Advertising Acceptance, IMC Code of Ethical Practices and internal company codes;
- product recalls for pharmaceuticals, medical devices, cosmetics and consumer products;
- conducting healthcare and anti-corruption compliance investigations;
- privacy and health information law and compliance;
- federal and provincial access to information laws and government relations; and
- in-house training on all aspects of compliance including healthcare, anti-corruption/anti-bribery, competition law, marketing & advertising and contract risk management.
