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03 July 2019
On 3 May 2019 two sets of proposed amendments to the Food and Drug Regulations were published:
The proposed amendments contain provisions which would streamline the process for providing access to unauthorised drugs for medical emergencies. Access to the drugs will continue to be facilitated through the Special Access Programme for human drugs and the Emergency Drug Release Programme for veterinary products. There are approximately 500 drugs with active status in the Special Access Programme and 45 in the Emergency Drug Release Programme.
The regulations are meant to facilitate access in the following circumstances:
Health Canada has released the following accompanying draft guidance documents:
Comments on the proposed regulatory amendments and the draft guidance documents may be submitted until 19 July 2019.
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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