Summary
The Regulations Amending the Food and Drug Regulations
(Shortages of Drugs and Discontinuation of Sale of Drugs) were
published in the Canada Gazette, Part II on June 29, 2016, and will
come into force in the spring of 2017. These amendments will
require a manufacturer to notify Health Canada within 30 days when
a drug has not been sold for 12 consecutive months. Further, these
amendments will require a manufacturer to publicly report drug
shortages or discontinuations of a drug through a new third-party
website.
Health Canada has released two draft guidance documents pertaining
to the proposed amendments to the Regulations: (a)
"Cancellation of a Drug Identification Number (DIN) and
Notification of the Discontinuation of Sales," and (b)
"Draft – Guide to reporting drug shortages and
discontinuations." Both are open for consultation until
September 28, 2016.
The zero sales notification requirement
In the spring of 2017, section C.01.014.12 of the Food and
Drug Regulations will come into force requiring drug
manufacturers to notify Health Canada within 30 days when a product
has not been sold for 12 consecutive months. Initially, this
requirement was only anticipated to apply to select categories of
drugs. However, Health Canada recently announced its intention to
amend the Regulations to require all products with a Drug
Identification Number (DIN), including
non-prescription products, to comply with this section of the
Regulations.
The purpose of the provision is to allow Health Canada to assign a
new "dormant" category in the Drug Product Database
(DPD) to better enable users to determine which
drug products are presently available on the Canadian market.
However, this would not affect the DIN for the product. Currently,
if a manufacturer stops sales of a product without cancelling the
DIN, the drug is still listed as "marketed" on the DPD
even though it is not available on the Canadian market.
Reporting on drug shortages and discontinuations
In the case of an actual or anticipated drug shortage, the
amendments to the Regulations will require an
authorization holder to report the anticipated start and end dates
of the shortage, and the actual or anticipated reason for the
shortage within six months of the anticipated start date, if
known.
In the case of a discontinuation of a drug, a DIN holder will be
required to report the DIN, the date on which the person
discontinued the sale of the drug, the latest expiration date of
the drug sold and the lot number of the drug to the Minister of
Health within 30 days after the day on which the sale of the drug
was discontinued.
Further, a DIN holder will be required to post information related
to the discontinuation of its drug on a third-party website at
least six months before the day on which the sale of the drug will
be discontinued, if known, or within five days after the day on
which the decision to discontinue the sale of drug is made, if the
decision is made within six months or less. Previously, the
Regulations only specified that a DIN holder notify Health Canada
within 30 days of discontinuation of sale of the drug.
Consultation on proposed amendments to the Regulations
Health Canada has released two draft guidance documents
pertaining to the proposed amendments to the Regulations:
"Cancellation of a Drug Identification Number
(DIN) and Notification of the Discontinuation of
Sales" and (b) "Draft – Guide to reporting drug
shortages and discontinuations." Both
guidance documents are open for consultation until
September 28, 2016. A copy of the "Draft
– Guide to reporting drug shortages and
discontinuations" can be obtained by contacting Health
Canada.
Link to Regulations
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