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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
Author: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. Beginning July 1, 2020 , industry will be able to distribute certain non-prescription...
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 pandemic....
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
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...
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)
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
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
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
Author: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. On January 30, 2020 the World Health Organization (WHO) declared 2019-nCoV, as...
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
Author: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. The Medical Devices Regulations have been established under the authority of the Food...