Registration - In-house Corporation

Subject Matters

• Consumer Issues
• Health
• Industry
• Intellectual Property
• Internal Trade
• International Relations
• International Trade
• Science and Technology
• Small Business
• Taxation and Finance

Subject Matter Details

Legislative Proposal, Bill or Resolution

• Provide input into the Government of Canada's negotiations regarding the Canada-European Union Comprehensive Economic Trade Agreement with respect to pharmaceuticals, counterfeit medicines, border measures, and intellectual property.

Policies or Program

• Innovation, Science and Economic Development Canada's Science & Technology strategy regarding the need for a balanced intellectual property regime and the important role competition plays in encouraging innovation.
• Patented Medicine Prices Review Board regarding claims of jurisdiction with respect to generic drug products associated with a patent.
• Proposals related to Health Canada's Identical Medicinal Ingredient Policy.
• Proposals to enhance transparency of the Health Canada Reconsiderations Policy for drug submissions
• Provide input into guidance with respect to the process for the approval and renewal of foreign sites for Drug Establishment License (DEL) holders.
• Provide input into policy discussions regarding the potential development of a national pharmacare program governments.
• Providing input into the development and implementation of an approval pathway for Subsequent Entry Biologics by Health Canada.
• To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat counterfeit pharmaceutical both nationally and globally.
• participation in consultations, providing comments on modernization of the Food and Drugs Act and related regulations regarding pharmaceuticals

Regulation

• The need for amendments to the Patented Medicines (Notice of Compliance) Regulations of the Patent Act and address operational concerns such as bringing finality to proceedings under the Regulations; allowing generic manufacturers to amend a Notice of Allegation; and providing meaningful damages and other disincentives to discourage abuse of the Regulatioins by brand name manufacturers.

Communication Techniques

• Written communication
• Oral communication

Government Institutions

• Canadian International Trade Tribunal (CITT)
• Finance Canada (FIN)
• Health Canada (HC)
• House of Commons
• Innovation, Science and Economic Development Canada (ISED)
• Patented Medicine Prices Review Board (PMPRB)
• Prime Minister's Office (PMO)
• Privy Council Office (PCO)
• Public Health Agency of Canada (PHAC)
• Senate of Canada
• Treasury Board Of Canada Secretariat (TBS)

Address:
85 Advance Road
Etobicoke, ON  M8Z 2S6
Canada

Telephone number: 416-236-2631
Fax number: 416-236-9022  

Parent Company Information

Mylan Pharmaceuticals ULC is not a subsidiary of any other parent companies.