Update- MI/MCI in Leave-on Cosmetics

By |April 21st, 2016|

In the December 2015 update to the Cosmetic Ingredient Hotlist, a restriction was added to the Methylisothiazolinone/Methylchloroisothiazolinone (MI/MCI) entry. MI/MCI when used in combination is a prohibited substance in leave-on cosmetic products. An implementation of six months was given from the date the change was published in the Cosmetic Ingredient Hotlist for companies […]

New Evidence Required for Light Emitting Medical Devices

By |April 4th, 2016|

Health Canada has announced that effective immediately evidence will be required to demonstrate that all hazards associated with thermal damage to the skin are eliminated or appropriately mitigated for light emitting medical devices. Affected devices include devices with laser, intense pulsed light (IPL), or light emitting diode (LED) energy sources.

The new evidence requirements impact class III and IV […]

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 […]

Conditional registrations for pesticides

By |March 28th, 2016|

As of June 1, 2016 Health Canada (HC) will no longer issue conditional registrations for pesticides.

Currently conditional registrations may be granted to pesticide products when the scientific review determines that the risks of a pesticide are acceptable, but more information is needed. In this cases, the pesticide is approved prior to the review of additional information.

In future, […]

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 […]

DSA gets timely DEL approval for a Foreign Manufacturing Site

By |August 24th, 2015|

Current Health Canada performance standards are at 250 days for approval of foreign sites.

AuditForeign site approvals require submission of one of the following types of evidence.

  • Regulatory Authority Inspection Report
  • Certificate of GMP Compliance for MRA Countries
  • Corporate or Consultant Audit Report

DSA recently filed a DEL amendment which was […]

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Our Team is Growing!

By |August 11th, 2015|

DSA Consultants is happy to announce the opening of two positions for Senior Quality Consultant. If you are interested in joining our team, please submit your resume online. If you know someone who would be a good fit, please share this message with them.

“Over 25 years in Business, with over 250 […]

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