Ontario’s provincial government recently announced expansions to its producer-led Blue Box recycling program. The update to Ontario’s extended producer responsibility (EPR) program will expand service to more communities and standardize the list of materials that can be recycled across the province. The expansion will also make producers fully responsible for the cost and operation of the program.
Health Canada announced that fees related to Master Files (MFs)—which provide confidential information about processes or components used in the manufacturing, processing, or packaging of a drug—will increase by 2% as of April 1, 2020. The new Master File fees are:
Health Canada has extended the deadline for mandatory filing of new Master Files (MFs) in electronic Common Technical Document (eCTD) format to January 1, 2020. A September 13, 2019 Notice from Health Canada summarizes the mandatory eCTD format requirements for regulatory activities already implemented and ones that will become effective at a future date.
In May 2018, Health Canada proposed requiring all new Canadian Drug Master Files (DMF) to be submitted in Electronic Common Technical Document (eCTD) format effective January 1, 2019. (See the PackagingLaw.com article, Health Canada Proposes Mandatory eCTD Formatted Master Files by 2019; Feedback Requested.) Comments on that proposal were due by August 10, 2018.
Health Canada has proposed requiring all new Canadian Drug Master Files (DMF) to be submitted in Electronic Common Technical Document (eCTD) format effective January 1, 2019. The deadline for commenting on this proposal is August 10, 2018.
In a May 7, 2018 Notice announcing the proposal, Health Canada outlined several requirements for eCTD formatted submissions, including:
Speaking at the 13th Biennial International Symposium on Worldwide Regulation of Food Packaging in Baltimore last month, Mr. Anastase Rulibikiye, Section Head of Health Canada’s Health Products and Food Branch, said that Canada is considering implementing a positive list system for the regulation of food-contact materials. After the meeting, he provided PackagingLaw.com with the following comments on the current status and future direction of the regulation of food-contact materials in Canada.
Letters of No Objection
Health Canada has released a final guidance document on “Master Files (MFs) – Procedures and Administrative Requirements.” The Guidance, released on April 28, 2017, replaces the 2008 Draft Guidance Document – Drug Master Files (DMFs).
Canada’s proposed regulations to implement the Safe Foods for Canadians Act (SFCA), which was adopted on June 7, 2012, include a section on packaging requirements for prepackaged food that is conveyed from one province to another or that is imported or exported. These requirements, found in Section 183 of the proposed regulations, state that the package must be:
Canada is reviewing its voluntary letter of no objection (LONO) program for food packaging materials, while continuing to process existing and new requests for assessments, said Elena Emelianova, Ph.D., Health Canada, at the Keller and Heckman Food Packaging Law Seminar, held October 19-20, 2016, in Arlington, VA. Speaking on the regulation of food-contact materials in Canada, she explained that the triggers behind the review are:
Health Canada announced that by March 31, 2016, all existing Drug Master Files (DMFs) in paper format must be replaced by electronic copies.