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Interim Labelling of products during COVID-19: Hand sanitizers, disinfectants, soaps and cleaning products

Interim Labelling of products during COVID-19: Hand sanitizers, disinfectants, soaps and cleaning products

Author:  Preetha Prabhu According to Statistics Canada, demand for hand sanitizer increased by 735% for the week ending March 14, 2020, relative to the same period last...

Distribution of low risk DIN/NPN products as samples

Distribution of low risk DIN/NPN products as samples

Author: Teri Dickinson, Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. Beginning July 1, 2020, industry will be able to distribute certain non-prescription drugs...

Health Canada Notice: Management of clinical trials during COVID-19

Health Canada Notice: Management of clinical trials during COVID-19

Author:  Preetha Prabhu On Apr. 22, 2020, Health Canada published a notice to clinical trial sponsors regarding management of clinical trials during the COVID-19...

The Ever-Changing Hard Surface Disinfectant Landscape in COVID-19 times

The Ever-Changing Hard Surface Disinfectant Landscape in COVID-19 times

Author: Teri Dickinson, Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. These days, the world of hard surface disinfectants and pathway to registration changes...

Regulatory Enrolment Process: Mandatory effective October 1, 2020

Regulatory Enrolment Process: Mandatory effective October 1, 2020

Author:  Preetha Prabhu On Mar. 30, 2020, Health Canada published a notice that as of October 1, 2020 use of the Regulatory Enrolment Process (REP) will be mandatory for...

Health Canada’s Interim Expedited Licensing Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers

Health Canada’s Interim Expedited Licensing Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers

Author:  Joe McCarthy, Dell Tech Laboratories Ltd. To facilitate the safe and efficient production of Natural Health Product (NHP) hand sanitizers during the COVID-19...

PAAB: Update on Digitization of Advertising / Promotional Systems (APS)

PAAB: Update on Digitization of Advertising / Promotional Systems (APS)

Author:  Preetha Prabhu In the light of evolving COVID-19, some manufacturers are modifying how their drug representatives interact with healthcare professionals. PAAB has...

Clinical Trial Regulatory Activities in eCTD

Clinical Trial Regulatory Activities in eCTD

Author:  Preetha Prabhu On February 19, 2020, Health Canada announced that the pilot for Clinical Trial regulatory activities in electronic Common Technical Document...

Information on Nitrosamine Impurity

Information on Nitrosamine Impurity

Author:  Preetha Prabhu In July 2018 Health Canada first became aware of the presence of nitrosamine impurity, N-nitrosodimethylamine (NDMA) in certain “sartan”...

The Emerging Viral Pathogen 2019-nCoV (Coronavirus) and what it means for Broad Spectrum Virucide Disinfectants

The Emerging Viral Pathogen 2019-nCoV (Coronavirus) and what it means for Broad Spectrum Virucide Disinfectants

Author: Teri Dickinson, Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. On January 30, 2020 the World Health Organization (WHO) declared 2019-nCoV, as belonging...

Canadian Product Monograph– Upcoming changes & Implementation Timeline

Canadian Product Monograph– Upcoming changes & Implementation Timeline

Author:  Preetha Prabhu Health Canada is committed towards improving the accessibility and quality of drug product information for Canadians by making it more relevant and...

Software as a Medical Device (SaMD): Definition and Classification

Software as a Medical Device (SaMD): Definition and Classification

Author: Teri Dickinson, Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. The Medical Devices Regulations have been established under the authority of the Food and...