Quality Medical Regulations Services QMRS Ottawa Ontario Canada email jalalqmrscom HEALTH CANADA Natural Health PRODUCTS REGULATIONS SITE LICENSING 9172014 wwwqmrscom 1 HEALTH CANADA Natural Health PRODUCTS REGULATIONS ID: 746146
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PRESENTED BYDr. Jalal Mokhalalati, B.Sc., M.Sc., Ph.D.Quality Medical Regulations Services (QMRS)Ottawa, Ontario, Canadaemail: jalal@qmrs.com
HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGObjective: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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGBackgroundAll 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGWhat 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGNHPs (complementary or alternative medicines, include:Vitamins
and mineralsHerbal remediesTraditional and Homeopathic medicines
Probiotics
Other
products like amino acids and essential fatty acids
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGNHPs 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.9/17/2014
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGAre 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGAre 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
effects
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGNHPs 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
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGHC Approval: NPN
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGHC Licensing Requirements:
Product licensingEvidence requirements for safety and efficacy
Site
licensingGood Manufacturing Practices
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGProduct licensingAll 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGEvidence requirements for safety and efficacyThe 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.
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGSite licensingAll 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGGood 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 LICENSINGPurpose 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
Applying for a Site Licence
Applicants
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
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGSubmission ManagementScreening
& Assessment of the ApplicationApplications 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
Deficiencies in the Application
Deficiencies 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGSite 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
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.
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
Products Manufactured, Packaged and Labelled at Foreign Sites
Canadian 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING2. 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGLicence Expiry and RenewalThe 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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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGLicence 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.
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HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSINGLicence 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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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
t
he
Canadian
regulationsSlide33
HEALTH CANADA: Natural Health PRODUCTS REGULATIONSSITE LICENSING
For Any Questions Please Contact:
Dr. Jalal Mokhalalati
Email: jalal@qmrs.com
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