Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more
Pharmaceutical manufacturers in Canada often enter into Product Listing Agreements (PLA), particularly with public payors, to facilitate their drug being reimbursed. It is common for PLAs to take the form of a first dollar...more
1. PAAB’s Accelerated Review Options -
In July 2022, the Pharmaceutical Advertising Advisory Board (PAAB) will launch four Accelerated Review Options (ARO) to its standard pre-clearance pathway, covering a range of...more
As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more
4/16/2021
/ Canada ,
Coronavirus/COVID-19 ,
Deadlines ,
Health Canada ,
Intellectual Property Protection ,
Manufacturers ,
Minister of Health ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Vaccinations
On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers...more
UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more
12/18/2020
/ Advertising ,
Canada ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Food & Drug Regulations ,
Health Canada ,
Imports ,
Infectious Diseases ,
Interim Measures ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Amendments ,
Record Retention ,
Supply Chain ,
Supply Shortages ,
Vaccinations
On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more
11/9/2020
/ Canada ,
Controlled Substances ,
Final Guidance ,
Food and Drug Act ,
Health Canada ,
Health Care Providers ,
Hospitals ,
Life Sciences ,
Manufacturers ,
New Regulations ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs
Health Canada has instituted numerous measures to help address and combat COVID-19, from facilitating access to COVID-19 products to protecting the public from false or misleading advertisements claiming to prevent, treat or...more
Health Canada has recognized for many years that the current regulatory regime on drug sampling, which significantly restricts the distribution of drug samples to both consumers and health care professionals, is outdated. For...more
6/9/2020
/ Amended Regulation ,
Health Canada ,
Health Care Providers ,
Manufacturers ,
Natural Products ,
New Guidance ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs
UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more
4/22/2020
/ Canada ,
Clinical Trials ,
Controlled Substances ,
Coronavirus/COVID-19 ,
Expedited Approval Process ,
Food and Drug Act ,
Guidance Documents ,
Health Canada ,
Medical Devices ,
Personal Protective Equipment ,
Pharmacies ,
Prescribing Authority ,
Prescription Drugs ,
Public Health Emergency ,
Relief Measures ,
Temporary Regulations ,
Transparency ,
Vaccinations ,
Virus Testing
In November 2019, we highlighted the key proposed amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). The proposed amendments aim to reduce...more
2/10/2020
/ Canada ,
Drug Interchangeability and Dispensing Fee Act (DIDFA) ,
Final Rules ,
Payment Caps ,
Pharmaceutical Benefits Scheme ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Product Labels ,
Proposed Amendments ,
Public Consultations ,
Rebates ,
Regulatory Burden
On October 28, 2019, the Ontario Ministry of Health and Long-Term Care (the Ministry) published proposed changes to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee...more
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal -
As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
3/5/2019
/ Apotex ,
Appeals ,
Biologics ,
Canada ,
Costco ,
Damages ,
Dismissals ,
FDA Approval ,
Filing Deadlines ,
Fines ,
Generic Drugs ,
Health Canada ,
Health Insurance ,
Janssen Pharmaceuticals ,
Leave to Appeal ,
Marketing ,
Medical Devices ,
Minor Children ,
Mylan Pharmaceuticals ,
New Guidance ,
Novartis ,
Orders of Prohibition ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Post-Market Approval ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rebates ,
Risk Assessment ,
Supreme Court of Canada ,
Teva Pharmaceuticals
The OHIP+ program, also known as Children and Youth Pharmacare program, was implemented on January 1, 2018 by the Province of Ontario to provide free prescription drug coverage for all children and youth 24 years of age or...more
On February 1, 2019, the Ontario Ministry of Health and Long-Term Care (“Ministry”) announced that CWC Pharmacies (Ontario) Ltd. (“Costco Pharmacies”), a subsidiary of Costco, was ordered to pay an Administrative Monetary...more
In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report). This Report outlines...more
11/30/2018
/ Biosimilars ,
CADTH ,
Canada ,
Drug Pricing ,
Global Market ,
Incentives ,
International Regulatory Standards ,
Pharmacies ,
Policies and Procedures ,
Prescribing Authority ,
Prescription Drugs