Journal of Developing Drugs
Open Access

Navigating the Canadian drug establishment licensing system

Joint Event on 8^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR & 8^th International Conference and Exhibition on Pharma Audit, GMP, GCP & Quality Control

June 08-09, 2018 | Philadelphia, USA

Doreen Clark Steen

Therapeutic Products Inc., Canada

Posters & Accepted Abstracts: J Develop Drugs

Abstract :

An establishment license since January 1, 1998 must be holded by all Canadian drug establishments in all the processes from fabrication to testing a drug. This requirement applies to all drug establishments. It is not permit, except in accordance with an establishment license, to fabricate, package/label, distribute, import or wholesale a drug; or perform tests, including examinations, required under Part C Division 2 of the Canadian Food and Drugs Regulations. Part C, Division 2 also applies to foreign buildings that supply Canadian importers with Finished Drug Products (FP), Active Pharmaceutical Ingredients (API), (including any FP and API intermediates) for import into Canada or import into Canada for future export. US Market Authorization Holders (MAH) must ensure any US site to plan to use in support a drug submission are aligned with an importer of record and the Health Canada (HC) process for GMP Canadian GMP compliance. dclarksteen@tpireg.com