Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations would expand definition of “claim for the medicinal ingredient”
By EsqSocial Corporation 27/04/21
On April 24, 2021, proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations were published (proposed PMNOC amendments). The proposed PMNOC amendments relate to the 2019 proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (proposed FDR amendments)... which would allow a generic manufacturer to file an abbreviated new drug submission for a different salt form of the medicinal ingredient in the Canadian reference product. The...
By: Smart & Biggar