HEALTH CANADA: Natural Health PRODUCTS REGULATIONS SITE LICENSING

www.qmrs.com

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PRESENTED BY

DR. JALAL MOKHALALATI, B.SC., M.SC., PH.D.QUALITY MEDICAL REGULATIONS SERVICES (QMRS)

OTTAWA, ONTARIO, CANADA

email: [email protected]

HEALTH CANADA: Natural Health PRODUCTS REGULATIONS

SITE LICENSING

9/17/2014

www.qmrs.com

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HEALTH CANADA: NATURAL HEALTH PRODUCTS REGULATIONS

SITE LICENSING

Objective:

The objective of this presentation is to provide attendees with some essential information on HC Natural Health products regulations and site licensing process

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SITE LICENSING

Background

All NHPs sold in Canada are subject to the Natural Health Products Regulations, which came into force on January 1, 2004.

To get product and site licenses, specific labelling and packaging requirements must be met, GMPs must be followed, and proper safety and efficacy evidence must be provided.

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SITE LICENSING

What are natural health products?

Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.

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SITE LICENSING

NHPs (complementary or alternative medicines, include:

• Vitamins and minerals

• Herbal remedies

• Traditional and Homeopathic medicines

• Probiotics

• Other products like amino acids and essential fatty acids 9/17/2014

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SITE LICENSING

NHPs are used and marketed for a number of health reasons, like the prevention or treatment of an illness or condition, the reduction of health risks, or the maintenance of good health. They must be safe to be used as over-the-counter products.

Products needing a prescription are regulated as drugs.

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SITE LICENSING

Are there risks to using NHPs?

While NHPs are generally safe, they are not risk free. Risks include:

• Manufacturing problems (Such as contamination, or incorrect ingredients)

• Unproven claims, which can lead people to use the wrong products for serious conditions

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SITE LICENSING

Are there risks to using NHPs?

• Not enough information for people to make an informed choice (like incorrect instructions or no warnings that a product may not be suitable for certain groups)

• Interaction with others prescription drugs

• Unwanted side effects9/17/2014

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SITE LICENSING

NHPs Marketing authorization?

To be licensed in Canada, NHPs must be safe, effective, of high quality and carry detailed label information

People can identify products that have been licensed for sale in Canada by looking for the eight-digit Natural Product Number (NPN) on the label.

A NPN means that the product has been authorized for sale in Canada and is safe and effective 9/17/2014

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SITE LICENSING

HC Approval: NPN

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SITE LICENSING

HC Licensing Requirements:

1. Product licensing

2. Evidence requirements for safety and efficacy

3. Site licensing

4. Good Manufacturing Practices

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SITE LICENSING

Product licensing

All NHPs must have a product license before they can be sold in Canada.

To get a license, applicants must give detailed information about the product to Health Canada, including: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s).

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SITE LICENSING

Evidence requirements for safety and efficacy

The safety and efficacy of NHPs and their health claims must be supported by proper evidence so that consumers and HC know the products are safe and effective.

The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks. 9/17/2014

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SITE LICENSING

Site licensing

All Canadian manufacturers, packagers, labelers, and importers of NHPs must have site licenses.

To get a license, sites must maintain proper distribution records, have proper procedures for product recalls and for the handling, storage and delivery of their products, and demonstrate that they meet GMPs requirements.

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SITE LICENSING

What is a Site Licence?The Regulations requires a manufacturer, packager, labeler, and importer of NHPs to hold a valid site licence. A site licence issued by the NHPD gives the licensee authorization to conduct these activities.These activities must be carried out according to the GMPs outlined under the Regulations.

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SITE LICENSING

Good Manufacturing Practices (GMPs)

Good Manufacturing Practices for NHPs cover:

product specifications, premises, equipment, personnel, sanitation program, operations, quality assurance, stability, records, batch samples, and recall reporting

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HEALTH CANADA: NATURAL HEALTH PRODUCTS REGULATIONSSITE LICENSING

Purpose of the Site Licence Regulations

• To ensure that HC is aware of all sites that are manufacturing, packaging, labelling, and importing NHPs in Canada.

• To set the requirement that businesses assure HC that they are meeting the regulatory requirements related to GMP

• To ensure that all NHPs are safe, of good quality, and are produced & stored in sites that comply with the GMP Regulations.

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Who Requires a Site Licence?

A site licence is required for the physical site in Canada where any persons or businesses wish to manufacture, package, label, and/or import a NHP for sale.

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Notes on Importing NHPs: Any business or individual that brings

into Canada a NHP for the purpose of sale is considered to be an importer.

Importers that ship a product directly to the retailer without first storing the product require a site licence

Retailers selling products that they themselves have imported are considered importers

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SITE LICENSING

Applying for a Site LicenceApplicants must provide evidence of GMP compliance in the form of one of the following: Audit Report from a NHPD recognized third party Quality Assurance Report (QAR) Form Drug Establishment Licence (DEL): Certificate of Compliance (CoC) or inspection

report issued by a Regulatory Authority from a country for which HC presently has a mutual recognition agreement (MRA)

GMP Certificate from a Qualified Authority 9/17/2014

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Submission Management

Screening & Assessment of the Application• Applications meeting administrative

requirements will be assigned a file number and a submission number.

• The NHPD aims to complete a site licence application within 45 days from the date of receipt to the date of issuance of the site licence or refusal.

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Deficiencies in the ApplicationDeficiencies in the application can range from minor and easily correctable to major or critical, There are four types of deficiencies: Administrative deficiencies Minor deficiencies Major deficiencies Critical deficiencies

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Site Licence Issuance:

The NHPD will only issue or amend a site licence when the applicant has submitted a complete submission with all the required supporting information to assess whether the site is fully compliant with the Regulations.

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Refusal to Issue a Site Licence: The NHPD may refuse to issue or amend a site licence when the site is not compliant with the GMP requirements• When the application is deficient, • When the applicant does not provide

additional information on request, or • When the information submitted is

false or misleading. 9/17/2014

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SITE LICENSING

Products Manufactured, Packaged and Labelled at Foreign SitesCanadian importers must be licensed and the onus is on them to provide evidence that imported products come from sites that meet Canadian GMPs or equivalent standards. Importers may submit either an Audit Report from third party or a QAR or any of the following of for their foreign sites:

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SITE LICENSING

1. Foreign Site Reference Number (FSRN) Authorization Form: A FSRN authorization form signed and dated by the Senior Official indicated for that company. FSRN's are issued to sites that have demonstrated compliance to GMPs Regulations via the FSRN application process.

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2. Certificate of Compliance (CoC)

Or inspection report (including corrective actions taken) issued by a Regulatory Authority from a country for which the HC Inspectorate presently has a mutual recognition agreement (MRA) related to GMP.

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3. Good Manufacturing Practices Certificate or inspection report (including the corrective actions taken) from a Qualified Authority. A qualified authority is an authority member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) or the United States Food and Drug Administration (USFDA).

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Licence Expiry and Renewal

The site licence must be renewed as follows:1. Every year, for the first three years2. Every two years, when the licensee has held the licence for three years from the date of issuance but less than nine years.3. Every three years, when the licensee has held the licence for nine years from the date of issuance or more.

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Licence Amendment

An amendment is required when:• Adding a new activity.• Adding a new building• Changing from manufacturing,

packaging, labelling, or importing a non-sterile dosage form to sterile dosage form.

• Adding a new foreign site.9/17/2014

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SITE LICENSING

Licence Suspension and Cancellation

HC may suspend a site licence when:

• The licensee is found to have contravened the Regulations

• When licensee make a false or misleading statement in the application

• When HC has enough evidence to believe that it is necessary to suspend the licence to prevent consumers injury .

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SITE LICENSING

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To Conclude:A site wishing to obtain a SL must demonstrate that requirements for GMP have been met. • To demonstrate GMP compliance, the site

will need to provide evidence that its buildings, equipment, procedures and proposed practices meet the requirements

• A Canadian importer must provide satisfactory evidence that the foreign site meets the Canadian GMP requirements required by the Canadian regulations

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SITE LICENSING

For Any Questions Please Contact:

Dr. Jalal MokhalalatiEmail: [email protected]

9/17/2014

HEALTH CANADA: Natural Health PRODUCTS REGULATIONS SITE LICENSING

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