Changes to the Non-prescription Drug Monograph Attestation Process

By |April 4th, 2016|

All non-prescription Category IV Monograph product (DINF) applications must include the new monograph attestation form.

Due to unfavorable results of the monograph attestation pilot, Health Canada has put in place processes to ensure that all DINF applications comply with the monograph.

During the review of DINF applications special attention will be given to the acceptability of medicinal and non-medicinal ingredient […]

Reminder to Generic Drug Manufacturers

By |March 7th, 2016|

Market authorization holders (MAH) of generic drug products regulated under Division 8 of the Food and Drug Regulations are required to file submissions to update their labelling to ensure consistency with that of the Canadian Reference Products (CRP) labeling.

On a monthly basis, Health Canada posts the Product Monograph Brand Safety Updates table. This table displays updates and/or new […]

Change to Ibuprofen listing on the Prescription Drug List

By |February 10th, 2016|

Health Canada has announced that certain uses of Ibuprofen will be changed to nonprescription status by amending the Prescription Drug List (PDL). This change only impacts Ibuporfen for human use; the current Veterinary listing will remain the same. The effective date of this change is six months from the date of Health Canada’s notice (February […]

Updates to DEL Applications & GMP Evidence Requirements for APIs

By |February 5th, 2016|

The Active Pharmaceutical Ingredient (API) regulations came into force on November 8, 2013. After a three year transition, November 8, 2016 will mark the full implementation of the Regulations.

Health Canada has posted several updates on changes that have been made to the way API submissions are processed and changes to the GMP evidence requirements of […]

Changes to Acetaminophen Labelling Standard

By |August 17th, 2015|

Health Canada is proposing changes to the Acetaminophen Labelling Standard to minimize the risk of liver damage and improve acetaminophen safety. The last update to the Labelling Standard was in 2009 when stronger warnings were adding to non-prescription products to reduce the risk of liver damage.

Acetaminophen is one of the most commonly used pain and […]

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Implementation of Advance Notice of Importation for Cosmetics and Drugs

By |August 10th, 2015|

The importation for sale of non-compliant cosmetics and drugs, including Natural Health Products is prohibited as per the Cosmetic Regulations and Food and Drug Regulations. However, the Regulations do allow for the importation of non-compliant cosmetics and drugs provided the following two conditions are met:

  • The importer provides advance notice to a […]
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Changes to the Drug Product Database

By |July 27th, 2015|

As of June 18, 2015 the Drug Product Database (DPD) includes approved but not yet marketed products in the online database.

The DPD is an online source of information on drugs approved for use in Canada for the public and industry by Health Canada. It includes human pharmaceutical and biological drugs, veterinary drugs, radiopharmaceutical drugs and […]

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