Drug Products: Includes prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

Health Canada defines a drug as: "any substance or mixture of substances manufactured, sold, or represented for use in (a) the diagnosis, treatment, mitigation, or prevention of a disease, a disorder, an abnormal physical state, or the symptoms thereof, in humans or animals, (b) restoring, correcting, or modifying organic functions in humans or animals, or (c) "disinfection" in premises in which food is manufactured, prepared, or kept." (HPFBI GMPs, Glossary of Terms).

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You have a drug product you would like to sell in Canada. Where do you start?

Drugs are regulated by Health Canada under Health Canada's Health Products and Food Branch Inspectorate (HPFBI). As outlined in the Health Canada Good Manufacturing Practices (GMP) guidelines: You are required to have a Drug Identification Number (DIN) for each drug product. You must have an Establishment Licence (EL).

All fabricators/manufacturers, packagers/labelers, importers, distributors, and wholesalers of drugs must follow the Canadian GMPs. Go to GMP Solutions for Drugs for more details. All fabricators/manufacturers, packagers/labelers, importers and distributors of drugs must have a distinct, independent Quality Control department responsible for GMP activities. For details, go to QCO Services.

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Quality & Compliance Services Inc. (Q&C®) can help you with all of your human and veterinary regulatory needs. We can:

• Perform Product Evaluations to determine your product's appropriate category (drug, NHP, cosmetic, etc.)
• Complete and submit DIN applications to Health Canada:
  • Category IV DIN applications
  • Full DIN applications
  • Labeling Standard DINs
  • Administrative changes
  • Notifiable changes
  
• Complete and submit Establishment Licence applications and/or amendments
• Evaluate potential drug products from a regulatory and marketing perspective
• Transition drug products to NHP where applicable
• Submit Precursor Class A and B, controlled substances, and narcotic licence applications to Health Canada on your behalf
• Complete documentation for:
  • New Drug Submissions (NDS)
    • Module 2, Section 2.3: Quality Overall Summary
  • Abbreviated New Drug Submissions (ANDS)
  • Clinical Trial Applications (CTA)
  • Common Technical Documents (CTDs)
• Liaise with Health Canada on your behalf
• Provide post-marketed drug services:
  • Changes to marketed drug products
  • Establishment licence applications and amendments
  • Site Reference File updates and submissions
• Provide Canadian Agent Services
• Submit Medical Device Licence Applications:
  • Medical Device Licence Applications (Class II, III, IV)
  • Investigational Testing Applications (for clinical studies)
  • Combination Product (drug/device) Submissions
  • Medical Device Establishment Licences
  • ISO 13485 consulting (Quality Systems for Medical Devices)

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With care and professionalism, we can take you through the entire process, from the initial drug application through setup of your quality system to release of your finished marketed product. Quality & Compliance Services Inc. can help you establish or re-organize your Quality Control system for DIN products to meet HPFBI requirements.
Go to QCO Services for Drugs for more information.

	Natural Health Products:

Natural health products are classified as: Vitamins and minerals (including many formulations for sunscreens and antiperspirants) Herbal remedies (including many formulations for anti-acne products) Homeopathic medicines Traditional medicines such as traditional Chinese medicines Probiotics Other products like amino acids and essential fatty acids

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Health Canada defines a natural health product (NHP) as:

"a substance set out in Schedule 1 of the Natural Health Products Regulations or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for use in:

• Diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state or its symptoms in humans;
• Restoring or correcting organic functions in humans; or
• Modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

However, an NHP does not include a substance set out in Schedule 2 of the Natural Health Products Regulations or any combination of substances that includes a substance set out in Schedule 2." (NHPD GMPs, Interpretations).

NHPs must be safe for consideration as over-the-counter products, be available for self-care and self-selection and not require a prescription to be sold.

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We Can Help You:

• Perform Product Evaluations to determine your product's appropriate category (drug, NHP, cosmetic, etc.)
• Determine submission requirements (confirming type of Product Licence Application [PLA] required)
• Prepare and submit:
  • Site Licence Applications (SLAs) and associated documents for Canadian, U.S,
     and foreign manufacturing facilities, including QA report
  • PLAs and associated documents
    • Non-traditional
    • Compendial
    • Transitional (DIN to NPN, i.e. drug to NHP)
    • Amendments, notifications, and renewals
• Address NHP Directorate (NHPD) queries, such as:
  • Information Request Notifications
  • Processing Deficiency Notifications
• Respond to any queries related to NHPs, whether the questions come from a client or the NHPD
• Transition drug product DINs to NPNs where applicable
• Act as your Qualified Quality Assurance (QA) Personnel

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For a comprehensive summary of the NHP GMP regulations, SLAs, PLAs, labeling and packaging requirements, and specific requirements for clinical trial products, read our NHPD QuickNote™. The FAQ section in this document provides a full list of links to NHP resource documents.

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As per the NHP GMPs:

• You need an NPN (Natural Product Number) for natural health products in Canada. There are separate Good Manufacturing Practices (GMPs) for drug products and natural health products
• Domestic fabricators/manufacturers, packagers/labelers, and importers must have a Site Licence. Sites with a site licence must comply with the NHP GMPs
• Importers must also appoint a Quality Assurance (QA) person in Canada to disposition product and to ensure compliance

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We can take you through the entire process, from the initial site application through setup of your quality system to release of your finished marketed product. Quality & Compliance Services Inc. can help you establish or re-organize your Quality Control system for NHPs to meet NHPD requirements. Go to QCO Services for more information.

Did you know? Quality & Compliance Services Inc. has advised and consulted on NHPs for many companies - we are familiar with the nuances of these new regulations, and continue to stay up to date regarding ongoing changes as they evolve. Our GMP associates are uniquely qualified to consult on NHPs; we were assisting clients with the transition from DIN to NHP before initial guidances were fully posted on the NHPD website.

	Cosmetics:

Cosmetics are best defined by what they are not. They are not: Products that have a therapeutic claim or that contain certain ingredients not permitted in cosmetics, for example sunscreens - these are considered drugs Products containing natural therapeutic ingredients, for example many toothpastes - these are considered natural health products (NHPs) Items where ingestion is intentional and that do not have a therapeutic effect or claim - these are considered food products Insect repellent lotions and sprays - these are considered pesticides Products providing a therapeutic benefit to animals (e.g., creams, lotions, or shampoos) - these are considered veterinary drugs

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Each of these categories are regulated under the Food and Drugs Act,
which defines cosmetics as:
"any substance or mixture of substances manufactured, sold, or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes."

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Quality & Compliance Services Inc. can help you determine the requirements for your cosmetic and personal care products. We can perform a product evaluation to determine your product's appropriate category (drug, NHP, cosmetic, etc.).

For your cosmetics, we can: Complete and submit Cosmetic Notification Forms Perform regulatory activities for importing of cosmetic products