Notice Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs

February 26, 2018
Our file number: 17-112414-458

Health Canada is pleased to announce the publication of the Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs. The document replaces the Changes in Manufacturer's Name and/or Product Name Policy (CMPN), written in 1998 and updated in 2001, 2015 and 2017.

The Therapeutic Products Directorate, the Natural and Non-prescription Health Products Directorate, and the Biologics and Genetic Therapies Directorate jointly developed the guidance document to clarify the requirements for eligible drug submissions and applications processed under the administrative pathway. These submissions and applications do not contain scientific data, or require regulatory review. In order to provide industry with sufficient time to become familiarized with the guidance document, there will be a 3 month delay before implementation. As of March 1st, 2018, sponsors wishing to file submissions and applications under the administrative pathway will be required to do so as per the conditions set within this guidance document. Among these conditions, is the requirement to file a drug submission or application with supporting data if certain deviations are made to a cross-licensed product in terms of its labelling, chemistry and manufacturing. These changes will not be eligible for processing under the administrative pathway. In cases where deviations from the parent product are filed and authorized, the cross-licensed product would no longer be eligible for any future post-authorization filings under the administrative pathway for labelling or chemistry updates to match the licensor, as aspects of the authorization would no longer be considered identical to the licensor. Also, please note that for disinfectant drugs, the implementation date of the aforementioned guidance document is April 1, 2019.

Note: Health Canada recognizes that deviations exist for some cross-licensed products approved under the old 1998 CMNP policy. As a result, previously authorized submissions and applications under the old policy that have deviated in the past (prior to the implementation of this guidance document) will be grandfathered and will continue to be eligible for administrative processing provided there are no further deviations and/ or changes to any existing licensing agreements (i.e., change in licensor or new licensing agreements).

Stakeholder comments received on the draft guidance document during the 60 day consultation period (February 17th until April 18th, 2017) were considered in the finalization of this guidance document. A summary of comments received is available upon request to the address below.

Questions or concerns regarding this guidance document should be directed to:

Office of Submissions and Intellectual Property
Health Products and Food Branch
Therapeutic Products Directorate
Address Locator: 0201A1
Health Canada
Ottawa, Ontario
K1A 0K9

Telephone: 613-941-7281
Fax: 613-946-5610

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