Canadian Establishment Licenses: Drugs, Supplements and Medical Devices
July 7, 2015 - Online event CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
Consumer goods such as over-the-counter drugs and natural health products (dietary supplements) may not be sold in Canada without prior receipt of a Health Canada drug establishment license or site license for the buildings involved with their import, manufacture and sale. This supply chain challenge is met by a combination of efforts amongst foreign exporters and Canadian importers. All who are involved should understand the Canadian requirements in order to ship consumer products such as over-the-counter drugs and natural health products to Canadian consumers without delay or obstacles. Canadian facilities who are also interested in producing medical marijuana or importing medical marijuana to their licensed facilities would first need to understand which additional responsibilities are required under the Marijuana for Medical Purposes Regulations (MMPR) of Health Canada. Areas Covered in the Session: Drug Establishment Licenses (drug products) Who requires a drug establishment license (DEL). How to apply for a DEL and which documents are required. Health Canada definitions for license holders and supply chain participants. DEL application forms, procedures and DEL fees. DEL pre-license inspections. Significance of standard operating procedures (SOP). Quality technical agreements. DEL maintenance. Applications for DEL amendments. Foreign facility compliance requirements. Which forms are required for drug establishment licenses. Active pharmaceutical ingredients requirements for DEL. Post license - inspection cycles, renewals Site Licenses (natural health products) How to apply. Required documentation for site license applications Post license - renewal of site licenses Future changes for site license applications. Product recall and sampling procedure expectations of Health Canada. Marijuana for Medical Purposes Regulations in Canada. Benefits of Health Canada’s website for compliance management and business opportunities Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1Ec9OYo support@compliance4all.com www.compliance4all.com