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Release of revised Certificates of Supplementary Protection Guidance

Canada - May 30 2019 On May 15, 2019, Health Canada released the third publication of the Guidance Document: Certificates of Supplementary Protection. The changes reflect...

Release of Guidance Document: Regulatory requirements for Drug Identification Numbers

Canada - May 30 2019 On May 3, 2019, Health Canada released the new Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs). The Guidance...

Procedural decisions in actions under the PMNOC Regulations: Common invalidity issues raised by different generics to be heard concurrently; only “second persons” can be named as defendants

Canada - April 29 2019 In Bayer v Apotex; Bayer v Teva, 2019 FC 191, the Court ordered that common validity issues in actions relating to Bayer's rivaroxaban (XARELTO)...

Tierney GB Deluzio.

Biosimilar update: the Pan-Canadian Oncology Biosimilars Initiative; Health Canada announces collaboration on study of comparative effectiveness and safety of biosimilar drugs

Canada - April 29 2019 The pan-Canadian Pharmaceutical Alliance (pCPA) and Cancer Care Ontario have partnered to create a pan-Canadian Oncology Biosimilars Initiative...

Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology

Canada - April 29 2019 Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March...