Changes to the Manufacturer's name and/or Product NamePublished on September 5, 2017
Author: Pinky Mazumder
The Policy on Changes in Manufacturer’s name and/or Product Name (CMPN) applies to drug submissions to Health Canada where the manufacturer's and/or product’s name is being changed due to a merger, corporate restructuring, licensing agreement, or a buy-out. According to this Health Canada Policy, a licensing agreement is defined as “an agreement between two firms whereby one firm supplies a drug product to another firm for sale under the second firm’s name”.
According to the CMPN Policy, a Drug Identification Number (DIN) Submission must be filed to Health Canada when the name of the manufacturer and/or product changes. However, a New Drug Submission (NDS) would be submitted for new drug products instead. Moreover, with a change in the product name the sponsor has to ensure that the proposed name change does not conflict with the conditions of the issued DIN, or in the case of a new drug, the issued Notice of Compliance (NOC).
The change in the name of the manufacturer and/or product also requires all other aspects of the product to be identical to that of the approved submission, with the exception of the manufacturer's name and/or product name being filed. According to the Policy, to apply for this change manufacturers are required to submit a Certification Form to certify that the other aspects of the approved product and its labels remain unchanged. It would be understood that the product name may change in the labels and product monograph if the product name is being changed for that submission. Moreover, with the recent update of the Regulations Amending the Food and Drugs Regulations on June 13th, 2017 for Non-Prescription drug products, the CMPN policy has updated as well. For human use prescription drug products that undergo a change in the name of the manufacturer and/or product, additional certification is required to certify that the new labels are similar in size and placement of the graphics, logos, and text to that of the approved labels. Mock-ups of the new labels and packaging are required for filing this change. In addition, if the name change is due to a merger, buy-out, or a licensing agreement, there are additional requirements for filing this change. Complete and detailed information is provided in the Policy document.
The submission of the change to the Manufacturer's and/or products name will be reviewed as per the Guidance on Management of Drug Submissions. Manufacturers must also notify Health Canada within 30 days of beginning sale of the product and inform the agency when the products marketed under the former name are no longer being sold. For more information, please refer to the Changes in Manufacturer’s Name and/or Product Name Policy from Health Canada.
Thank you for reading Regulated Affairs, the CAPRA blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.
Policy - Changes in Manufacturer’s Name and/or Product Name
Artificial Intelligence – Revolutionizing the Healthcare Industry
What is Artificial Intelligence? Artificial intelligence (AI) is a broad term for a category of algorithms and models that perform tasks and exhibit behaviors such as...
Technology Continues to Transform Healthcare and the Regulatory World
Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more...
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...