Novartis Pharmaceuticals Canada Inc.
Registration:
12
of
39
(2014-11-17
to
2015-04-09)
Legislative Proposal, Bill or Resolution
- Food and Drugs Act & Regulations as it relates to Drug Export restriction and cross border trade.
- The bill, formerly known as Bill C-6, Canada Consumer Product Safety Act with respect to creating a new system to regulate consumer products that pose, or might reasonably be expected to pose, a danger to human health and safety.
Legislative Proposal, Bill or Resolution, Regulation
- Bill C-17 - monitoring the implementation of the revised Food and Drugs Act Vanessa's Law (and Regulations)
Policies or Program
- Canada's orphan drug framework as it relates to reimubursement recommendations in Canada, and also in regards to the alingment of the framework with processess that are already implemented in the US and EU.
- Common Drug Review as it relates to reimbursement recommendations for decision-making process and framework.
- Federal Public Drug Plans, with respect to the reimbursement of drug products for the Federal plan beneficiaries
- Science and Technology Strategy, advocating for the development of a Biopharma sector in support of more research & development in Canada.
Policies or Program, Regulation
- Subsequent Entry Biologics (SEBs): information regarding approval framework supported and protected by Regulations in harmonization with approaches taken by the European Union or the U.S. for instance.
Regulation
- Patented Medicine Prices Review Board (PMPRB) Regulations as related to reporting requirements and pricing guidelines.
- Patented Medicines (Notice of Compliance) Regulations as it relates to regulation of intellectual property for therapeutic products.