DSA Consultants

About DSA

Over 25 years in Business, with over 250 Satisfied Clients. Our team is committed to your success and work hard to obtain your regulatory approvals and help you obtain compliance ratings from Health Canada. We measure our success by your success.

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 […]

Medical Device Single Audit Program (MDSAP) Update

By |March 30th, 2016|

The Medical Device Single Audit Program (MDSAP) Pilot will conclude December 31, 2016.

MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. MDSAP will be the sole mechanism for demonstrating compliance with the quality management system (QMS) requirements of the Medical Device Regulations.

The […]

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, […]

Updated Site License (SL) Guidance Document

By |March 23rd, 2016|

The Natural and Non-prescription Health Products Directorate (NNHPD) has posted an updated SL guidance document. Along with the updated guide the Quality Assurance Report (QAR) and Summary of Net Changes (SNC) forms have also been updated.

Important changes to note to the SL review process include:

  • SL renewals will be refused for companies who have not conducted activities in […]

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 […]

Handling Medical Devices Establishment License Audit

By |February 24th, 2016|

DSA Consultants was recently hired by a local Mississauga firm to handle their Medical Devices Establishment License Audit with Health Canada. The firm is currently licensed as an Importer of Medical Devices into Canada. They were referred to DSA by one of our existing clients.

The first step of the project was to conduct an onsite assessment. We […]

DSA Travels to Mexico

By |February 18th, 2016|

Recently, one of our Senior Quality Consultants was tasked with an audit of a contract manufacturing site in Mexico.

The purpose of the audit was to help prepare the firm for an eventual audit by Health Canada. Our Senior Quality Consultant spent 5 days at the audit site reviewing master production records, stability, validation and other […]

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 […]

What to Look For When Buying a Natural Health Product

By |August 31st, 2015|

As a regulatory consultant for natural health products (NHPs), I get a lot of questions from clients, friends and family on how to differentiate between a NHP and a drug and what to look for when buying a NHP.

With the increasing popularity of healthy living, NHPs are no longer only found in health food stores. […]

Comments Off on What to Look For When Buying a Natural Health Product