Overview
What do you need to know in 2017 as the Canadian government prepares to legalize marijuana? Read our article.
Torys' practitioners are experienced in the relevant regulatory laws, guidelines and policies—both federal and provincial—and regularly advise on all of the regulatory issues affecting the research, testing, approval, post-approval compliance, pricing, advertising and correction/withdrawal/recall of drugs, food and beverage products, cosmetics, consumer products, nutritional products, and medical devices/diagnostics products in Canada.
Our team also assists clients with conducting compliance audits, privacy laws, recalls and withdrawals, non-compliant regulatory submissions, and obtaining regulatory approvals, including presubmission meetings with regulatory authorities (NHP applications, NDS, SNDS, IND, DIN and other license submissions).
Our cross-border expertise extends to advising clients on the differences in compliance in Canada and the United States, patent listings in Canada, U.S. websites and promotion and advertising of U.S.-labelled product for purchase by Canadians, compliance and cross-border issues in corrective actions, as well as privacy issues associated with collecting data from Canadians and exporting to servers located in the United States and advising on consents and website terms and conditionsOur expertise includes:
- classification and regulation of a product
- assisting product pre-approval in Canada
- advice on best practices for maintaining a product's market exclusivity
- corporate compliance codes, regulatory compliance audits, GMP compliance
- product packaging, labeling, advertising, promotions, contests, websites
- quality assurance and pharmacovigilance agreements and commercial agreements with a regulatory component
- pricing and market access of products
- the interface between regulatory submissions, patent listings and data protection
- Patented Medicines Prices Review Board (PMPRB) hearings and negotiations with PMPRB staff in Canada
- advertising complaints and disputes before PAAB, ASC and other organizations
- public and private formularies/payers and agreements with such formularies/payers
- privacy issues associated with collecting, using and sharing data, personal information and personal health information, including corrective action associated with disclosures
- planned and unplanned inspections by regulatory authorities (pre- and post-approval, and cross-border)
- compliance and cross-border issues in corrective actions, product corrections, recalls and withdrawals
- consumer, patient and physician support websites