Consultation – Proposed new regulatory activity types for transactions filed to the Marketed Health Products Directorate (MHPD)
From Health Canada
Current status: Open
Opened on January 15, 2019 and will close to new input on March 15, 2019.
Health Canada is proposing a set of new regulatory activity types to be used in lieu of the Undefined Data Post-market Vigilance regulatory activity, filed to the Marketed Health Products Directorate. Currently, the Undefined activity is used by Industry to file multiple regulatory activities and transactions to Health Canada, such as the Risk communication document, and the Issue-related summary document. With the new set of regulatory activity types, Health Canada will be able to better classify and review these activity types.
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Who is the focus of this consultation
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Goals of the consultation
The objective of this notice is to provide awareness of this proposal and obtain feedback from stakeholders if they have any concerns.
Key questions for discussion
- Are the proposed new regulatory activity types acceptable to stakeholders?
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