Compliance & Enforcement for NHPs: What
Retailers need to Know
Presented by: Carl Carter
Director, Regulatory Affairs and Policy Development, CHFA
June 20, 2013
Key Topics
• Your store shelves
– NHPs
– Licensing of NHPs
• The Compliance and
Enforcement
transition
• Dealing with a visit
from an inspector or
government official
2
Your store shelves: NHPs
• Under the Natural Health Products Regulations, which came
into effect on January 1, 2004, natural health products (NHPs)
are defined as:
• Vitamins and minerals
• Herbal remedies
• Homeopathic medicines
• Traditional medicines such as traditional Chinese medicines
• Probiotics
• Other products like amino acids and essential fatty acids
3
Licensing of NHPs in Canada
• NHPs must be approved by the Natural Health
Products Directorate and be found as safe, effective
and of high quality
• Market authorisation is indicated with an NPN or DINHM
– Exempted Products – In February 2013, the temporary
Natural Health Products (Unprocessed Product License
Applications) Regulations was repealed – therefore no more
Exemption Numbers (ENs)
• Next step: A transition plan for Compliance &
Enforcement
4
Compliance and Enforcement
5
NHP Compliance and Enforcement – Phase 1
• March 1, 2013 – November 30, 2013 will
focus on compliance promotion:
• Health Canada will enhance awareness of
the Natural Health Products Regulations, so
that companies have what they need to
understand and comply with the
Regulations.
• Companies may use this time to plan and
prepare for phasing out of distribution of
their non-market authorized products.
6
NHP Compliance and Enforcement – Phase 2
• December 1, 2013 – August 31, 2014:
• At the retail level, the phasing out of any non-market
authorized product continues.
– Products that have an active submission number with the NHPD or
products that have undergone minor modifications which are not
reflected in the current labelling, will be considered a lower priority
for enforcement, unless a risk to health or additional noncompliances are identified
• NHPs will be expected to have market authorisation
and respect the terms of their market authorisations,
including formulation and labelling.
7
NHP Compliance and Enforcement
•
As of September 1, 2014, the
expectation is that all NHPs
(including at the retail level) will
have an NPN or DIN-HM before
coming onto the market, and
respect the terms of their market
authorisation.
•
All licensed NHPs captured on
LNHPD
EN database continues to be
available
•
8
NHP Compliance and Enforcement – Overview
• This is an 18-month transition period
• The transition period will enable companies to make
adjustments to business practices and phase-out
products that are not in compliance
• The repeal of NHP-UPLAR did not signal an
immediate change in compliance and enforcement
for NHPs
• The risk-based approach continues to be applied
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Dealing with an Inspector/Government
Official
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Dealing with an Inspector/Government
Official
• Inspector presence at retail level
expected to be minimal
– Focus is on suppliers/distributors/license holders
– More involvement after Phase 1 of Compliance and
Enforcement?
• Inspectors will likely be from the HPFBI
and/or CFIA
NHPs
Foods
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Dealing with an Inspector/Government
Official
• Retailer To Do List:
– Ask for ID: Get contact name/dept./business card
– Ask questions: Find out nature of business/length
of meeting
– Keep records/Make notes
– Keep CHFA in the loop
• Goal is consumer safety, not to “shut you
down”
12
Recent Developments
• New Director General at the Health Products
and Food Branch Inspectorate
– Ms. Robin Chiponski, replacing Ms. Diana Dowthwaite
• The Natural Health Products Directorate’s mandate
has expanded and will now cover over-the-counter
drugs
• Mr. Paul Glover has been promoted from Assistant
Deputy Minister to Associate Deputy Minister of
Health
13
CHFA’s Regulatory Team
Krista Jajko
Associate Manager, Regulatory
Affairs
Carl Carter
Director, Regulatory Affairs and
Policy Development
Sonia Salyk
Associate, Regulatory Affairs and
Policy Development
Questions?