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Communication on changes to the Non-prescription Drug Monograph Attestation Process Background The Non-Prescription Drug Monograph Attestation Pilot was launched on August 11, 2014, by the Natural and Non-prescription Health Products Directorate (NNHPD), to assess the…
Notice: Guidance Document: Tamper-resistance Formulations of Opioid Drug Products March 30, 2016 Our file number: 16-103566-811 Opioid drugs are subject to the Food and Drugs Act and the Controlled Drugs and Substances Act ( CDSA ). An opioid drug may be sold in Canada following…
Notice: Limiting the Strength of Acetaminophen to 325 mg per Dosage Unit in Prescription Combination Products This Notice serves to inform sponsors that effective immediately, Health Canada is limiting the strength of acetaminophen in prescription combination drug products to 325…
Notice: Release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance November 30, 2018 Our file number: 18-109026-937 Health Canada is pleased to announce the release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance . The Post-Notice…
Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (PDF Version - 124 K) Date Adopted 2010/03/05 Revised Date 2016/11/14 Administrative Changes Date 2017-04-20 Revised Date 2022-08-26 Health Products and Food Branch Foreword Guidance…
Notice: Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) February 10, 2017 Our file number: 17-101644-531 The Therapeutic Products Directorate (TPD) of the Health Products and Food Branch (HPFB) of Health Canada is revising the…
Notice: Guidance Document - Fees for the Right to Sell Drugs The Office of Submissions and Intellectual Property has updated their contact information. March 14, 2017 Our file number: 17-103106-215 This guidance document has been updated, including its Document Change Log, to…
Notice - Upcoming Changes to the Annual Drug Notification Form March 14, 2017 Our file number: 17-103105-718 The Annual Drug Notification Form (ADNF) is intended to assist manufacturers in complying with section C.01.014.5 of the Food and Drug Regulations which requires that…
Notice - Intellectual Property Hold for Notifiable Change Submissions April 7, 2017 Our file number: 17-104009-682 This notice applies to subsequent entry manufacturers under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) and the data protection…
IGDRP/Health Canada/CAPRA Symposium Regulatory Collaboration and Emerging Issues in Generic Medicines - IGDRP and other Initiatives Responding to Today’s Demands and Future Challenges June 9, 2017 (Ottawa, Ontario) The availability of quality medicines plays an increasingly…
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